- The FDA has granted dermal carcinogenicity (CARC) waiver for Timber Pharmaceuticals Inc’s (NYSE:TMBR) TMB-001, a topical isotretinoin formulated using the company’s patented IPEG delivery system.
- The positive opinion is based on the 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.
- The move allows the company to forgo a 2-year dermal rodent carcinogenicity study.
- “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.”
- TMB-001 is currently being investigated in the Phase 3 ASCEND study for moderate to severe subtypes of congenital ichthyosis, 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.
- Price Action: TMBR shares are up 87.90% at $2.80 during the premarket session on the last check Monday.
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