PYC Therapeutics Agrees on Framework for Registrational Study Design for Blinding Eye Disease Drug Candidate New Drug Application
MT Newswires Live
Mar 16
PYC Therapeutics (ASX:PYC) agreed with the US Food and Drug Administration (FDA) on a framework for the design of a registrational study intended to support a new drug application for drug candidate VP-001 in retinitis pigmentosa type 11 (RP11), according to a Monday filing with the Australian bourse.
The company and the US FDA agreed on the nomination of the primary endpoint, the nomination and ranking of key secondary endpoints, as well as the nomination of other secondary endpoints, the filing said.
The FDA also confirmed that the company can incorporate natural history data from its study on RP11 patients with the randomized sham control arm data from the proposed registrational trial as part of the new drug application submission, per the filing.
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