Fast track granted for Timber’s congenital ichthyosis candidate

The FDA has granted a fast track designation to Timber Pharmaceuticals’ topical isotretinoin for the treatment of the two most severe forms of congenital ichthyosis, the company announced in a press release.

The fast track designation for TMB-001, a topical formulation of isotretinoin that uses the Timber’s IPEG delivery system, will allow the company expedited reviews and FDA meetings to discuss the drug’s development in treating two types of congenital ichthyosis (CI) — X-linked recessive ichthyosis and autosomal recessive CI lamella ichthyosis.

“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 CI who currently have no FDA-approved treatments and limited standard of care options,” John Koconis, Timber Chairman and CEO, said in the 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.”

In a phase 2b trial, patients treated with TMB-001 had a clinically meaningful reduction in CI severity. The company will initiate a phase 3 trial within the next 60 days, the release said.