PYC Therapeutics progresses RP11 drug candidate to mid-stage human trials

PYC Therapeutics Limited (ASX: $PYC) has announced the approval of the Safety Review Committee (SRC) for the progression of its Single Ascending Dose (SAD) study in patients with Retinitis Pigmentosa type 11 (RP11) to a fourth patient cohort. The investigational drug candidate, VP-001, has been deemed safe and well tolerated, leading to the initiation of a Multiple Ascending Dose (MAD) study and an amendment to the SAD protocol to allow for higher dosing. PYC expects to commence the MAD study in Q2 2024 and aims to initiate a registrational trial in 2025, with the potential for a New Drug Application by 2027.

Executive Commentary on Progression of RP11 Drug Candidate

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. 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.

Summary of PYC Therapeutics Announcement

PYC Therapeutics has successfully progressed its RP11 drug candidate, VP-001, to mid-stage human trials after receiving approval from the Safety Review Committee (SRC). The drug candidate has been found to be safe and well tolerated, allowing for the initiation of a Multiple Ascending Dose (MAD) study and an amendment to the Single Ascending Dose (SAD) protocol to allow for higher dosing. The Company aims to commence the MAD study in Q2 2024 and anticipates initiating a registrational trial in 2025, with the potential for a New Drug Application by 2027. PYC's Chief of Research and Development, Dr. Sri Mudumba, expressed confidence in the activity and safety profile of the drug candidate, highlighting the potential for extended exposure window and higher dosing. The Company's drug development programs target monogenic diseases, with a focus on genetic diseases, and it is set to progress additional drug programs targeting blinding eye diseases and Polycystic Kidney Disease in the near future.