PYC Therapeutics (ASX:PYC) has has been approved to escalate doses of its drug candidate VP-001, treating Retinitis Pigmentosa 11, in a second patient cohort. Dosages will be lifted to 75 micrograms (mcg).
The second cohort comprises patients part of the company’s Multiple Ascending Dose (MAD) study which runs alongside a Single Ascending Dose (SAD) study. Both Phase 1/2 studies are ongoing.
A safety review body ticked off on higher doses for the MAD group on Tuesday.
PYC reports that patients already doses with VP-001 in either stage of studies so far have shown “disease progression arrested and improved vision.”
Members of the SAD cohort have already taken 75mcg doses with no adverse effects, PYC reported on Tuesday. Higher doses in the MAD group will ultimately allow PYC to collect more data to present to regulators.
To that end, the company will approach the US FDA in an attempt to win research fast-track status for its drug once data from the ongoing studies is back with the company which is set for Q1 of next year.
Retinitis Pigmentosa type 11 is a genetic condition which can be simply described as a thickening of the retina.
Fluid abnormally collects in the eye after birth, the condition mainly affects children and generally causes blindness around middle age if left unchecked, according to the Lions Eye Institute.
PYC last traded at
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