PYC to finalize registrational study for RP11 after positive FDA feedback

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Clinical-stage biotechnology company PYC Therapeutics recently held a type B meeting with the US Food and Drug Administration (FDA) to discuss requirements for a new drug application (NDA) for the company’s investigational drug candidate, VP-011. VP-001 is an investigational drug candidate for the treatment of retinitis pigmentosa type 11 (RP11).¹

Combined phase 1/2 studies for VP-001 are currently in progress. Improvements in visual acuity, assessed by low luminance visual acuity (LLVA), and retinal sensitivity, assessed by microperimetry, have both been observed in patients who have received VP-001.¹ PYC plans to progress VP-001 into a regional study in RP11.

PYC proposed the inclusion of a sham control arm within the study, as well as proposed inclusion and exclusion criteria for the registrational trial. The FDA confirmed that these were acceptable to the regulator.

Using the guidance obtained from the meeting with the FDA, PYC will finalize the registrational study design before seeking FDA endorsement through a type D meeting. That meeting is expected to occur in the second half of 2025. PYC will then initiate the registration trial for VP-001 once final alignment with the FDA is complete.

Reference:

1. FDA Alignment on Registrational Trial Design RP11 Program - PYC Therapeutics Limited (ASX:PYC). Listcorp.com. Published June 22, 2025. Accessed June 25, 2025. https://www.listcorp.com/asx/pyc/pyc-therapeutics-limited/news/fda-alignment-on-registrational-trial-design-rp11-program-3204265.html

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