The initial three doses for AMD are monthly but after that many patients can extend to 8 or 12 week intervals. That’s certainly something that has been chased in recent drug development in AMD – to extend the dosing interval.
I’m not sure what dosing interval will be chosen for PYC’s clinical trial. Hopefully, it will be at least 3 months.
ProQR’s sepofarsen demonstrated a half-life of 58 days in preclinical.
In the Phase 1/2 trial of sepofarsen in LCA10, administration was every 3 months, over 1 year. That trial was a success.
In their Phase 2/3 trial, they trialled a second injection after 3 months and then at 6 monthly intervals, over 2 years. That trial was a failure. But I don't think that was because of dosing interval. Another current Phase 2/3 trial of QR-401 in Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene is also using the 3 month, followed by 6 month dosing schedule.
PYC Price at posting:
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