PYC Therapeutics (ASX:PYC) Aligns with FDA on Registrational Trial Design for RP11 Treatment
Clinical Progress
PYC Therapeutics (ASX: PYC) has reported that its drug candidate, VP-001, has demonstrated improvements in visual acuity and retinal sensitivity in patients with Retinitis Pigmentosa type 11 (RP11) during ongoing Phase 1/2 studies.
FDA Alignment
The company engaged with the US Food and Drug Administration (FDA) to discuss the path to a New Drug Application (NDA) for VP-001. The FDA confirmed that including a sham control arm and using either Low Luminance Visual Acuity (LLVA) or microperimetry as primary endpoints are acceptable for the registrational Phase 2/3 trial. Additionally, the FDA requires a minimum of 24 months of data to support the NDA.
Future Plans
PYC Therapeutics will finalise its registrational study design based on the FDA’s guidance and seek protocol endorsement in the second half of 2025. Following FDA approval, the company plans to initiate the registrational trial for VP-001.
Motley Fool contributor Lauren Surplice has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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