PYC Therapeutics Limited (ASX:PYC) has received approval from the Safety Review Committee (SRC) for escalation in dosing to a fourth patient cohort.
This fourth patient cohort will receive the investigational drug candidate known as VP-001 at a dose of 75 micrograms per eye. The approval comes following review of the safety and tolerability data for patients in:
- cohort 1 (3 micrograms per eye);
- cohort 2 (10 micrograms per eye); and - cohort 3 (30 micrograms per eye).
“We have reached a dose at which we expect to see activity of the drug candidate in patients with RP11. This has triggered us to commence the repeat dose study in order to gain greater insight on the efficacy profile of this drug candidate following an extended exposure window in the retina of RP11 patients,” PYC’s Chief of Research and Development, Dr. Sri Mudumba, said.
“At the same time, the safety and tolerability profile of the drug candidate observed to date allows for higher dosing. We have therefore amended the SAD study protocol to escalate dosing further and we will convert these doses into the MAD study following confirmation that VP-001 is safe and well-tolerated at these higher doses too.”
Patients are expected to receive the 75 microgram dose of VP-001 in the updated SAD study before the end of May. A Multiple Ascending Dose (MAD) study is expected to commence in May and PYC will provide a detailed overview of the study design prior to initiation of this clinical trial.
Both studies are expected to have concluded in early 2025, at which time the Company will evaluate the safety/tolerability and efficacy profile of VP-001 before progressing into a registrational trial in the event of successful outcomes.
