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FDA Grants Fast Track Designation to TMB-001
The designation is for the treatment of X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).
Timber Pharmaceuticals announced the FDA’s decision to grant a Fast Track designation to TMB-001, a topical isotretinoin formulated using the company’s patented IPEG delivery system, for the treatment of (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).1
“Based on the clinical success that TMB-001 has shown to date, we believe we have an important opportunity to dramatically improve the lives of people living with congenital ichthyosis (CI) who currently have no FDA-approved treatments and limited standard of care options,” said John Koconis, chairman and CEO of Timber, in the press release. “The designation of Fast Track status is a significant achievement that speaks to the unmet need in CI. Now we can communicate frequently with the FDA throughout our pivotal Phase 3 ASCEND clinical trial with the goal of earlier drug approval and access by patients.”
CI is a group of rare genetic keratinization disorders that leads to dry, thickened, and scaling skin, the release explained. Patients with moderate to severe subtypes of CI, like X-linked ichthyosis (XLRI) and autosomal recessive congenital ichthyosis (ARCI), which includes lamellar ichthyosis (LI), often have considerable hyperkeratosis and skin scaling. There are currently no approved FDA treatments for these conditions.2
The phase 2b CONTROL study (NCT04154293) evaluating TMB-001 in moderate-to-severe CI was completed in September of 2021. The company in the release state that it plans to start the phase 3 ASCEND clinical trial in the next 60 days based on the feedback from the FDA.
For full results from the CONTROL study, click here.
References:
1. Timber Pharmaceuticals announces fast track designation granted by FDA for TMB-001 in severe subtypes of congenital ichthyosis. April 28, 2021. Accessed April 28, 2022. https://finance.yahoo.com/news/timber-pharmaceuticals-announces-fast-track-120000223.html
2. Timber pharmaceuticals announces positive end-of-phase 2 meeting with FDA for tmb-001 in moderate to severe congenital ichthyosis. GlobeNewswire News Room. Published March 2, 2022. Accessed April 28, 2022. https://www.globenewswire.com/news-release/2022/02/03/2378451/0/en/Timber-Pharmaceuticals-Announces-Positive-End-of-Phase-2-Meeting-with-FDA-for-TMB-001-in-Moderate-to-Severe-Congenital-Ichthyosis.html
