PYC to Finalize Registrational Study for RP11 After Positive FDA Feedback

PYC Therapeutics, a clinical-stage biotechnology company, has announced progress toward finalizing its registrational study for VP-001 following productive discussions with the US Food and Drug Administration (FDA). The company recently held a type B meeting with the FDA to address requirements for a new drug application (NDA) for VP-001, its investigational drug candidate targeting retinitis pigmentosa type 11 (RP11).

VP-001: Investigational Therapy for Retinitis Pigmentosa Type 11

VP-001 is currently under investigation for the treatment of RP11, a genetic retinal disorder that leads to progressive vision loss. Combined phase 1/2 studies of VP-001 are underway, with encouraging early outcomes. Patients treated with VP-001 have demonstrated improvements in visual acuity, measured by low luminance visual acuity (LLVA), and in retinal sensitivity, assessed through microperimetry.

Study Design Gains FDA Support

During the type B meeting, PYC proposed a registrational trial design that includes a sham control arm, along with specific inclusion and exclusion criteria. The FDA confirmed that these elements were acceptable, providing a clear pathway for advancing the study.

Next Steps Toward Registration

Leveraging the guidance received from the FDA, PYC will now finalize the registrational study design. The company plans to seek further FDA endorsement through a type D meeting, anticipated in the second half of 2025. Following alignment with the agency, PYC intends to initiate the registration trial for VP-001 in patients with RP11.