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Highlights
- PYC Therapeutics advances its treatment study for Retinitis Pigmentosa 11.
- Higher doses of VP-001 approved for testing in second patient group.
- Company aims to seek fast-track status from U.S. FDA for this research.
PYC Therapeutics (ASX:PYC) has reached a pivotal stage in its research on Retinitis Pigmentosa 11, a genetic eye disease affecting children. The ASX healthcare stock has gained approval to escalate the dose of its experimental drug VP-001, moving from the initial dose to 75 micrograms (mcg) in its second patient cohort. This advancement marks an important step in PYC’s Multiple Ascending Dose (MAD) study, conducted alongside a Single Ascending Dose (SAD) study in the ongoing Phase 1/2 trials.
The increase in dosage follows a review by a safety committee, which gave the green light for the MAD group to proceed with higher doses. Initial findings from both the MAD and SAD cohorts indicate promising effects. According to PYC, patients who have received VP-001 treatment so far have shown a halt in disease progression, with some even experiencing vision improvement. These early results are a positive indication for the drug’s potential efficacy.
Participants in the SAD cohort, who have already received the 75 mcg dose, reported no adverse effects, adding to the confidence in the safety profile of VP-001. For the MAD cohort, higher doses will allow PYC to collect comprehensive data on VP-001’s impact over time, which the company plans to present to regulatory bodies.
PYC Therapeutics is also preparing to seek fast-track designation from the U.S. Food and Drug Administration (FDA) once it completes the current studies, expected by the first quarter of next year. Fast-track designation, if granted, would facilitate a quicker regulatory review process, potentially speeding up the drug’s availability for patients in need.
Retinitis Pigmentosa type 11, the focus of PYC’s study, is a genetic disorder that leads to a thickening of the retina. This condition results from an abnormal accumulation of fluid in the eye after birth, affecting mainly children. Left untreated, it generally progresses to cause blindness by middle age. According to the Lions Eye Institute, this disorder remains a significant cause of inherited blindness, making effective treatments critical for affected individuals.
PYC Therapeutics, which recently traded at AUD 0.19 per share, is advancing in a field with few treatment options, working toward a breakthrough for patients with this rare, progressive disease.
