PYC now has all of the information required to submit a regulatory application to progress into human trials for PYC-001.So it looks like the company is on track to commence Phase 1 SAD sometime in Q3.
It really has become a neck and neck race with Stoke Therapeutics, which is similarly developing an antisense therapy for ADOA.
Stoke was seemingly about a year ahead of PYC in its ADOA program but it appears that the race will be closer than that. Last week Stoke presented its Phase 1 SAD study design and simply stated that the study would commence in 2024.
It looks like there won’t be competition for patients at this stage. Stoke is planning to run its SAD study in the UK and potentially the EU whereas PYC’s study, I believe, will be held in the US.
ARVO 2024 OSPREY (stoketherapeutics.com)
(20min delay)