Timber Pharmaceuticals, Inc. (NYSE:TMBR) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TMB-001 for the treatment of X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).
The company concluded the Phase 2b CONTROL study evaluating TMB-001 in moderate to severe congenital ichthyosis (CI).
John Koconis, Chairman and Chief Executive Officer, said, “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”.
Moving forward, Timber Pharma anticipated to start the pivotal Phase 3 ASCEND clinical trial to evaluate TMB-001 within the next 60 days.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Timber Pharmaceutical is trading up 29 percent at $0.35 in the pre-market session
