Timber Pharmaceuticals (TMBR) Announces FDA Grant of CARC Waiver for TMB-001
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Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced the U.S. Food and Drug Administration (FDA) has granted a dermal carcinogenicity (CARC) waiver for TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system. The positive opinion is based on results of a 39-week repeat dose dermal toxicity study that demonstrated no evidence of skin or organ carcinogenicity from chronic applications of TMB-001 in rodents and allows the Company to forgo a 2-year dermal rodent carcinogenicity study.
“Many dermatologists are familiar with oral isotretinoin, but high-dose and chronic oral therapy cannot be tolerated by most patients due to systemic toxicity,” said John Koconis, Chairman and Chief Executive Officer of Timber. “We are committed to delivering a new topical treatment option for people living with moderate to severe congenital ichthyosis (CI). The CARC waiver is important because we can avoid a costly and lengthy non-clinical study, which we believe will allow us to push ahead with our TMB-001 program as quickly and efficiently as possible. We have reached 70% enrollment in our pivotal Phase 3 ASCEND study and are working to open the final sites in Italy this month.”
CI is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin. TMB-001 is currently being investigated in the Phase 3 ASCEND study for the treatment of moderate to severe subtypes of CI including lamellar ichthyosis and X-linked ichthyosis that affect about 80,000 people in the U.S. In 2018, the FDA awarded an Orphan Products Grant to support clinical trials evaluating TMB-001, including the Phase 3 ASCEND study. Timber has also received both Breakthrough Therapy Designation and Fast Track Status from the FDA for TMB-001.
About Timber Pharmaceuticals, Inc.
Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. The Company is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.
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