FDA Grants PYC Fast Track Designation for Lead Candidate for Treatment of Retinitis Pigmentosa

Rare Daily Staff

The U.S. Food and Drug Administration granted PYC Therapeutics Fast Track designation for its VP-001 program, the first experimental drug designed to address retinitis pigmentosa type 11.

The Fast Track process is designed to facilitate the development, and the review of drugs to treat serious conditions and fill an unmet medical need with Fast Track status that often leads to earlier drug approval and access by patients. Benefits of the Fast Track designation include

increased frequency of meetings with the FDA to discuss the drug’s development plan,

eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and

the potential for a Rolling Review in support of a New Drug Application.

PYC will utilize the Fast Track designation to work with the FDA on advancing this important drug program towards patients on an accelerated timeline.

VP-001 is the first potential treatment for Retinitis Pigmentosa Type 11 (RP11), a blinding eye disease that begins in childhood and ultimately leads to legal blindness in middle age. The disease affects approximately 1 in every 100,000 people and is caused by insufficient expression of the PRPF31 gene in the retina.

There are currently no treatment options available for patients with RP11 nor are there any in clinical development.

VP-001 is a precision therapy that aims to restore the expression of the PRPF31 gene back to levels required for the normal function of the retina. VP-001 utilizes PYC’s proprietary drug delivery technology to overcome the major challenge for RNA drugs by ensuring that sufficient drug reaches its target inside the cells affected by RP11.