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WO2025150048A1 - Traitement et prévention du carcinome basocellulaire avec une composition topique comprenant du patidegib - Google Patents

Traitement et prévention du carcinome basocellulaire avec une composition topique comprenant du patidegib

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Publication number
WO2025150048A1
WO2025150048A1 PCT/IL2025/050029 IL2025050029W WO2025150048A1 WO 2025150048 A1 WO2025150048 A1 WO 2025150048A1 IL 2025050029 W IL2025050029 W IL 2025050029W WO 2025150048 A1 WO2025150048 A1 WO 2025150048A1
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WO
WIPO (PCT)
Prior art keywords
subject
months
bcc
patidegib
another embodiment
Prior art date
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Pending
Application number
PCT/IL2025/050029
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English (en)
Inventor
Ofra Levy-Hacham
Ervin Epstein
Jean Tang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sol Gel Technologies Ltd
Original Assignee
Sol Gel Technologies Ltd
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Filing date
Publication date
Application filed by Sol Gel Technologies Ltd filed Critical Sol Gel Technologies Ltd
Publication of WO2025150048A1 publication Critical patent/WO2025150048A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4355—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having oxygen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Definitions

  • the present invention is directed to a method of treatment and/or prevention of basal cell carcinoma, and a method of delaying the formation of new basal cell carcinoma in a subject comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof.
  • Basal cell carcinoma is a common form of skin cancer, a subtype of Non Melanoma Skin Cancer (NMSC). BCC arises from abnormal, uncontrolled growth of basal cells, and is driven by the hedgehog (HH) signaling pathway which is considered to be a major signal transduction pathway during embryonic development, but it usually shuts down after birth.
  • HH hedgehog
  • Activated Hedgehog (HH) signaling driven by mutations in the tumor-suppressor gene Patched (PTCH) and/or the G-protein-coupled receptor Smoothened (SMO) is known to promote oncogenic signaling and drives the growth of BCC. Mutations of the human patched gene such as PTCHI and PTCH2 are associated with migraine basal cell carcinoma syndrome and basal cell carcinoma.f i]
  • Nonsurgical therapies include radiation therapy, chemotherapy, and immunotherapy. These therapies can be useful for definitive treatment of primary tumors and some recurrent BCC tumors and for relieving symptoms associated with inoperable tumors. However, some of these therapies also can have significant unpleasant side effects. Side effects of radiation therapy and certain chemotherapies are well documented.
  • One form of immunotherapy involves intralesional injections of interferon. While interferon therapy can be effective against BCC, the multiple intralesional injections can require several clinic visits per week for many weeks and are painful.
  • NBCCS Nevoid basal cell carcinoma syndrome
  • SUFU SUFU negative regulator of hedgehog signaling
  • Affected patients have both developmental anomalies and postnatal tumors, including multiple BCCs, at an average age of 20 to 21 years, odontogenic keratocysts, and medulloblastoma [3],
  • Gorlin syndrome affects individuals which develop multiple (dozens to thousands) of microscopic and macroscopic BCCs, various benign hair follicle hamartomas, palmar, and plantar pits in addition to skeletal defects (bifid ribs and syndactyly), central nervous system abnormalities (calcification of the falx cerebri and agenesis of the corpus callosum), craniofacial features (enlarged skull, hypertelorism, and frontal bossing), and benign odontogenic keratocysts of the jaw.
  • Rombo syndrome Rombo syndrome was first described in a family with vermiculate atrophoderma and peripheral vasodilation with cyanosis in childhood, milia, trichoepitheliomas, hypotrichosis in adulthood, and BCCs developing in the third and fourth decade [4], Rombo syndrome appears to be transmitted in a dominant pattern; however, a causative mutation had not been identified.
  • Bazex-Dupre-Christol syndrome is an X-linked dominant disorder characterized by congenital hypotrichosis, follicular atrophoderma, milia, and multiple BCCs [5],
  • Muir-Torre syndrome is a rare, autosomal dominant condition caused by mutations in DNA mismatch repair genes MLH 1 , MSH2, and MSH6.
  • Oculocutaneous albinism - Oculocutaneous albinism is a group of autosomal recessive disorders of melanin biosynthesis presenting with a spectrum of visual disturbances and hypopigmentation of the skin and hair.
  • OCA Oculocutaneous albinism
  • SCC is the most common type of cancer occurring in patients with OCA, but BCC and melanoma also occur [7] .
  • the present invention provides a method of treatment and/or prevention of basal cell carcinoma, comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the pharmaceutical composition is administered for a period of about 12 months, about 18 months, about 24 months, about 36 months, chronic or for a lifetime.
  • the pharmaceutical composition is administered for a period of about 12 months.
  • the pharmaceutical composition is administered for a period of about 18 months.
  • the pharmaceutical composition is administered for a period of about 24 months.
  • the pharmaceutical composition is administered for a period of about 36 months.
  • the pharmaceutical composition is administered chronically.
  • the pharmaceutical composition is administered for lifetime.
  • the present invention provides a method of treatment and/or prevention of basal cell carcinoma, comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the pharmaceutical composition is administered for a period of about 12 months - 10 years, about 12 months - about 5 years, about 18 months - about 10 years, about 18 months - about 5 years, about 12 months- about 24 months, about 18 months - about 24 months, about 18 months - about 36 months, chronic or for a lifetime.
  • the present invention provides a method of treatment and/or prevention of basal cell carcinoma, comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the pharmaceutical composition is administered for a period of at least 12 months, at least 18 months, at least 24 months, at least 36 months, chronic or for a lifetime.
  • the period of administration is at least 12 months.
  • the period of administration is at least 18 months.
  • the period of administration is at least 24 months.
  • the period of administration is at least 36 months.
  • the period of administration is chronic.
  • the period of administration is for a lifetime.
  • the subject has less than 6 facial BCC lesions and suffers from a disorder comprising non-melanoma skin cancer, Rombo syndrome, Bazex-Dupre-Christol syndrome, Xeroderma pigmentosum, Muir-Torre syndrome, Oculocutaneous albinism, Gorlin syndrome, or any combination thereof.
  • the subject suffers from Gorlin syndrome.
  • a method of treatment and/or prevention of basal cell carcinoma comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the pharmaceutical composition is administered for a period of more than 12 months; wherein the subject has at least one of (i) less than 6 BCC lesions; (ii) the subject does not have a genetic mutation PTCH; (iii) the subject has SMO, SUFU or any combination thereof; (iv) the subject suffers from a disorder comprising non-melanoma skin cancer, Rombo syndrome, Bazex-Dupre-Christol syndrome, Xeroderma pigmentosum, Muir-Torre syndrome, Oculocutaneous albinism, Gorlin syndrome, or any combination thereof.
  • a method of treatment and/or prevention of basal cell carcinoma comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need.
  • the methods provided herein are directed to treatment of BCC referring to reduction of BCC lesion size or in clinically resolved BCC over time. In another embodiment, the methods provided herein are directed to the treatment of BCC, which results in a reduction of BCC lesion size.
  • the BCC lesion size is reduced by about 1-100%. In another embodiment, the lesion size is reduced by about 5%. In another embodiment, the BCC lesion size is reduced by about 10%. In another embodiment, the BCC lesion size is reduced by about 20%. In another embodiment, the lesion size is reduced by about 30%. In another embodiment, the lesion size is reduced by about 40%. In another embodiment, the lesion size is reduced by about 50%.
  • the BCC lesion size is reduced by about 60%. In another embodiment, the BCC lesion size is reduced by about 70%. In another embodiment, the lesion size is reduced by about 75%. In another embodiment, the BCC lesion size is reduced by about 80%. In another embodiment, the BCC lesion size is reduced by about 85%. In another embodiment, the BCC lesion size is reduced by about 90%. In another embodiment, the BCC lesion size is reduced by about 95%. In another embodiment, the BCC lesion size is reduced by about 100%.
  • the methods provided herein are directed to the treatment of BCC which results in clinically resolved BCC, particularly the BCC disappeared completely.
  • the treatment of BCC lesion results in clinically resolved BCC, wherein the lesion is no longer suspected as BCC.
  • the methods provided herein comprise reduction of the number of nSEBs (new surgically eligible BCCs).
  • the methods provided herein comprise prevention of formation of new BCC.
  • the methods provided herein comprise prevention of formation of new surgically eligible BCCs (nSEBs).
  • a method for preventing formation of new BCCs comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need.
  • a method of preventing formation of new BCCs wherein the pharmaceutical composition is administered for a period of more than 12 months, and wherein the subject eligible for the treatment and/or prevention is selected according to any one of the following criteria (i) the subject must have less than 6 BCC lesions; or (ii) the subject does not have a genetic mutation PTCH; or (iii) the subject must have at least 6 BCC lesions and a genetic mutation PTCH. In another embodiment, the subject must have at least 6 facial BCC lesions. In another embodiment, the subject must have at least 6 facial BCC lesions and a genetic mutation PTCH.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein the formation of new BCC is delayed/inhibited in comparison to the time to first formation of new BCC with vehicle administration.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein the delay/inhibition time is compared to vehicle.
  • the delay/inhibition is between at least 5-60%, 5-50%, 5-35%, 5-30%, 10-40%, 10-30%, 15-40%, of time compared to vehicle.
  • the delay/inhibition is at least about 5% of time compared to vehicle.
  • the delay/inhibition is at least about 10% of time compared to vehicle.
  • the delay/inhibition is at least about 15% of time compared to vehicle. In another embodiment, the delay/inhibition is at least about 20% of time compared to vehicle. In another embodiment, the delay/inhibition is at least about 25% of time compared to vehicle. In another embodiment, the delay/inhibition is at least about 30% of time compared to vehicle. In another embodiment, the delay/inhibition is at least about 35% of time compared to vehicle. In another embodiment, the delay/inhibition is at least about 40% of time compared to vehicle. In another embodiment, the delay/inhibition is at least about 45% of time compared to vehicle. In another embodiment, the delay/inhibition is at least about 50% of time compared to vehicle.
  • a method of delaying/inhibiting the formation of first new basal cell carcinoma in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein the formation of new BCC is delayed in comparison to the time to first formation of new BCC with vehicle administration.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is administered for a period of about 3 months, about 6 months, about 9 months, about 12 months, about 18 months, about 24 months, about 36 months, chronic, or for a lifetime.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is administered for a period of at least 3 months, at least 6 months, at least 9 months, at least 12 months, at least 18 months, at least 24 months, at least 36 months, chronic, or for a lifetime.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is administered for a period of about 1 months -10 years, about 3 months -10 years, about 6 months -10 years, about 9 months -10 years, about 12 months - 10 years, about 12 months - about 5 years, about 18 months - about 10 years, about 18 months - about 5 years, about 1 months- about 24 months, about 3 months- about 24 months, about 6 months- about 24 months, about 9 months- about 24 months, about 12 months- about 24 months, about 3 months- about 36 months, about 6 months- about 36 months, about 9 months- about 36 months, about 12 months- about 36 months, about 18 months - about 24 months, about 18 months - about 36 months, chronic or for a lifetime.
  • the methods provided herein comprise topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the subject has at least one of (i) at least 6 facial BCC lesions; (ii) a genetic mutation PTCH; or (iii) at least 6 facial BCC lesions and a genetic mutation PTCH.
  • the methods provided herein comprise topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the subject has at least one of (i) at least 6 BCC lesions; (ii) a genetic mutation PTCH; or (iii) at least 6 facial BCC lesions and a genetic mutation PTCH.
  • the methods provided herein comprise topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the subject has at least one of (i) at least 1 BCC lesion and (ii) the subject have a genetic mutation PTCH (iii) at least one disorder comprising non-melanoma skin cancer, Rombo syndrome, Bazex-Dupre-Christol syndrome, Xeroderma pigmentosum, Muir- Torre syndrome, Oculocutaneous albinism, or Gorlin syndrome; and (iv) the subject suffers from immunosuppression; (v) the subject was exposed to radiation, asbestos, sun, or tanning salons.
  • a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof
  • the composition comprises patidegib in an amount of about 0.1-2% w/w, 0.1-3% w/w, 0.1-4% w/w, 0.1-5 %w/w, 1-2% w/w, 1.5-3% w/w, 1-3% w/w, 1-4% w/w, 1-5% w/w, 2-4% w/w, 2-5% w/w, 2-6% w/w, or 0.1-6% w/w.
  • the composition comprises patidegib in an amount of about 1% w/w, 2% w/w, 3% w/w, 4% w/w, 5% w/w, or 6% w/w.
  • the composition comprises patidegib in an amount of about 2% w/w, 3% w/w, or 4% w/w.
  • the composition comprises patidegib in an amount of about 2%.
  • a method of treatment and/or prevention of basal cell carcinoma comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the pharmaceutical composition is administered for a period of more than 12 months; and wherein the composition comprises patidegib in an amount of about 2% w/w.
  • a method of treatment and/or prevention of basal cell carcinoma comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the pharmaceutical composition is administered for a period of more than 12 months; wherein the composition comprises patidegib in an amount of about 0.1% w/w to about 6% w/w, wherein the subject eligible for the treatment and/or prevention has at least one of (i) less than 6 BCC lesions, and (ii) the subject does not have a genetic mutation PTCH.
  • the composition comprises patidegib in an amount of about 2% w/w, 3% w/w, or 4% w/w. In another embodiment, the composition comprises patidegib in an amount of about 2% w/w.
  • the subject eligible for the treatment and/or prevention has less than 6 BCC lesions. In another embodiment, the subject eligible for the treatment and/or prevention has less than 6 facial BCC lesions. In another embodiment, the subject eligible for the treatment and/or prevention has less than 6 BCC lesions and (ii) the subject does not have a genetic mutation PTCH.
  • the composition comprises patidegib in an amount of about 0.1-2% w/w, 0.1-3% w/w, 0.1-4% w/w, 0.1-5% w/w, 1-2% w/w, 1.5-3% w/w, 1-3% w/w, 1-4% w/w, 1-5% w/w, 2-4% w/w, 2-5% w/w, 2-6% w/w, or 0.1-6% w/w.
  • the composition comprises patidegib in an amount of about 1% w/w, 2% w/w, 3% w/w, 4% w/w, 5% w/w, or 6% w/w.
  • the composition comprises patidegib in an amount of about 2% w/w, 3% w/w, or 4% w/w. In another embodiment, the composition comprises patidegib in an amount of about 2% w/w.
  • the subject treated by the methods provided herein does not develop drug resistance. In another embodiment, the subject treated by the methods provided herein does not develop drug resistance even following a discontinuation period of administration, during the treatment.
  • the present invention provides a method of treatment and/or prevention of basal cell carcinoma, comprising topically administering a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, to a subject in need, wherein the pharmaceutical composition is administered for a period of more than 12 months, wherein the subject does not develop drug resistance.
  • the subject does not develop drug resistance following a discontinuation period of administration during the treatment.
  • a method of treatment and/or prevention of BCC comprising topically administered a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, to a subject in need thereof, wherein the composition is administered for a period of more than 12 months, more than 18 months, more than 24 months, more than 36 months, at least 1-10 years, more than 1 year, more than 2 years, more than 3 years, more than 4 years, more than 5 years, more than 6 years, more than 7 years, more than 8 years, more than 9 years, more than 10 years, or chronically, or for a lifetime; and wherein the subject does not develop drug resistance.
  • a method of treatment and/or prevention of BCC comprising topically administered a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, to a subject in need thereof, wherein the composition is administered for a period of more than 12 months, more than 18 months, more than 24 months, more than 36 months, at least 1-10 years, more than 1 year, more than 2 years, more than 3 years, more than 4 years, more than 5 years, more than 6 years, more than 7 years, more than 8 years, more than 9 years, more than 10 years, or chronically, or for a lifetime; and wherein subject does not develop drug resistance following a discontinuation period of administration during the treatment.
  • a method of treatment and/or prevention of BCC comprising topically administered a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, to a subject in need thereof, wherein the composition is administered for a period of more than 12 months, wherein the period of administration comprises (i) consecutive 12 months of administration (ii) followed by a discontinuation period (iii) followed by continuation of administration, wherein the subject does not develop drug resistance .
  • the discontinuation period is of 1, 2, 3, 4, 5, 6, 7, 8 months or between 1-3 months, 1-24 months, between 2-12 months, between 3-12 months, between 3-8 months, between 3-10 months.
  • the continuation of administration is at least 1 month, at least 3 months, at least 6 months, at least 9 months, at least 12 months, at least 18 months, at least 24 months, at least 36 months, chronically, or for a lifetime.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma lesions in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein the subject does not develop drug resistance.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma lesions in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein subject does not develop drug resistance following a discontinuation period of administration during the treatment.
  • a method of delaying/inhibiting the formation of new basal cell carcinoma lesions in a subject comprising topically administering to a subject a pharmaceutical composition comprising patidegib or a pharmaceutically acceptable salt thereof, wherein the period of administration comprises (i) consecutive 12 months of administration (ii) followed by a discontinuation period (iii) followed by continuation of administration, wherein the subject does not develop drug resistance.
  • the discontinuation period is of 1, 2, 3, 4, 5, 6, 7, 8 months or between 1-3 months, 1-24 months, between 2-12 months, between 3-12 months, between 3-8 months, between 3-10 months.
  • the period of administration of the methods of this invention does not affect the drug efficacy.
  • the drug efficacy is not affected.
  • DGME diethylene glycol monoethyl ether
  • EP European Pharmacopoeia
  • NF National Formulary
  • HPC hydroxypropyl cellulose
  • USP United States Pharmacopeia
  • - not applicable a free-base patidegib equivalent, excluding the bound hydrochloride salt, 2-propanol solvate, and water.
  • b reported concentration is inclusive of the bound hydrochloride salt, 2-propanol solvate, and water associated with the drug substance.
  • Placebo Comparator Patidegib Topical Gel, Vehicle
  • the participant must be age at least 18 years of age at the Screening Visit.
  • the participant must meet diagnostic criteria for the basal cell nevus (Gorlin) syndrome including major criterion #3a plus 1 additional major criterion or plus 2 additional minor criteria listed below.
  • Medulloblastoma (Modification of criteria of V Kimonis et al Am J Med Genet 69: 299-308, 1997).
  • the participant must have 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter ⁇ 5 mm present on the face prior to Randomization (Baseline/Day 1).
  • the participant is willing to have blood collected to measure circulating drug levels.
  • the participant is willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator. Moisturizers and emollients are allowed.
  • the participant is willing for all facial BCCs to be evaluated and treatment recommendations made only by the Investigator.
  • the participant is willing to forego treatment of facial BCCs with anything other than the study IP except when the Investigator believes that delay of treatment of a facial BCC potentially might compromise the health of the subject.
  • the only allowed form of treatment is surgical.
  • Non-facial BCCs may be removed at the discretion of the Investigator or Primary Skin Care Physician (PSCP).
  • PSCP Primary Skin Care Physician
  • the subject has previously participated in a clinical trial evaluating patidegib topical gel.
  • the participant has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
  • topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
  • these are use of the following: a. 5 -fluorouracil, imiquimod, diclofenac, or Ingenol mebutate (except as topical treatment to discrete non-facial BCCs) systemically or topically to the skin within the 2 months prior to the Screening Visit.
  • b Systemic chemotherapy within 1 year prior to the Screening Visit.
  • Known inhibitors of the Hedgehog signaling pathway such as vismodegib, sonidegib, itraconazole
  • Photodynamic therapy (PDT) except to localized non-facial, individual BCCs within 2 months prior to the Screening Visit.
  • the participant is known to have a hypersensitivity to any of the ingredients in the study medication formulation.
  • the participant has uncontrolled systemic disease.
  • the participant has been treated for invasive cancer within the past 5 years excluding nonmelanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.
  • nonmelanoma skin cancer Stage I cervical cancer
  • ductal carcinoma in situ of the breast or chronic lymphocytic leukemia (CLL) Stage 0.
  • CLL chronic lymphocytic leukemia
  • the participant has current, recent (within five half-lives of the experimental drug or if half-life not known, within the past 6 months prior to the Screening Visit), or planned participation in an experimental drug study while enrolled in this study.
  • the participant is a WOCBP who is unwilling or unable to comply with pregnancy prevention measures.
  • the participant is pregnant or breastfeeding.

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Abstract

L'invention concerne une méthode de traitement et/ou de prévention du carcinome basocellulaire, et une méthode pour retarder la formation d'un nouveau carcinome basocellulaire chez un sujet, comprenant l'administration par voie topique d'une composition pharmaceutique comprenant du patidégib ou un sel pharmaceutiquement acceptable de celui-ci.
PCT/IL2025/050029 2024-01-11 2025-01-09 Traitement et prévention du carcinome basocellulaire avec une composition topique comprenant du patidegib Pending WO2025150048A1 (fr)

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COSIO TERENZIO, DI PRETE MONIA, DI RAIMONDO COSIMO, GAROFALO VIRGINIA, LOZZI FLAVIA, LANNA CATERINA, DIKA EMI, ORLANDI AUGUSTO, RA: "Patidegib in Dermatology: A Current Review", INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, MOLECULAR DIVERSITY PRESERVATION INTERNATIONAL (MDPI), BASEL, CH, vol. 22, no. 19, 3 October 2021 (2021-10-03), Basel, CH , pages 10725, XP093193978, ISSN: 1422-0067, DOI: 10.3390/ijms221910725 *
SOL-GEL TECHNOLOGIES, LTD.: "Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults with Gorlin Syndrome - NCT06050122", CLINICAL TRIALS, CLINICALTRIALS.GOV, 21 November 2023 (2023-11-21), XP093335011, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT06050122?term=NCT06050122&rank=1&a=2> *

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