• PYC's drug candidate VP-001 demonstrated improvements in visual acuity and retinal sensitivity in RP11 patients
• FDA confirmed key aspects of PYC's proposed registrational trial design, including sham control arm and endpoints
• FDA requires minimum 24-months of data to support NDA for VP-001

PYC Therapeutics, a clinical-stage biotechnology company, has announced that it has obtained alignment with the US Food and Drug Administration (FDA) on the registrational trial design for its drug candidate VP-001 to treat the blinding eye disease Retinitis Pigmentosa type 11 (RP11). RP11 is a genetic disease with no treatment options currently available. PYC's VP-001 has demonstrated improvements in both visual acuity and retinal sensitivity in patients enrolled in the ongoing Phase 1/2 studies. PYC is planning to progress VP-001 into a registrational Phase 2/3 study and recently engaged the FDA on the path to a New Drug Application (NDA) for the product. Key outcomes of the meeting included confirmation by the FDA that PYC's proposal to include a sham control arm within the registrational trial is acceptable, the proposed inclusion and exclusion criteria for the study are acceptable, and either of the two endpoints PYC is tracking in the ongoing Phase 1/2 studies (Low Luminance Visual Acuity or Microperimetry) can be nominated as the primary endpoint in the registrational study. The FDA also set an expectation that the NDA will require a minimum of 24-months of data in support of VP-001. PYC will use this guidance to finalize the registrational study design before seeking endorsement of the protocol by the FDA in the second half of 2025 and initiating the trial.

PYC will use the guidance obtained from the FDA to finalize the registrational study design for VP-001 before seeking endorsement of the protocol by the FDA in H2 2025 and initiating the trial.