Presentation of Clinical Proof of Concept in Lead Program

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Stock PYC Therapeutics Ltd (PYC.ASX)
Release Time 28 Apr 2025, 9:02 a.m.
Price Sensitive Yes
 PYC Therapeutics Presents Clinical Proof of Concept in Lead Program
Key Points
  • VP-001 demonstrates statistically significant improvements in vision on a registrational endpoint
  • Clinically meaningful gains in visual acuity and improved quality of life reported by patients
  • VP-001 is safe and well-tolerated with no serious adverse events
Full Summary

PYC Therapeutics today announces that data from ongoing Phase 1/2 clinical trials of its drug candidate VP-001 for the treatment of Retinitis Pigmentosa type 11 (RP11) will be presented at international scientific conferences in May 2025. The data shows that treatment with VP-001 is associated with statistically significant improvements in vision on a registrational endpoint, clinically meaningful gains in visual acuity and improved quality of life as reported by patients. Importantly, VP-001 has been shown to be safe and well-tolerated with no treatment or procedure-related serious adverse events reported in any patient to date. The differentiation of this data set across both safety and efficacy dimensions highlights the utility of PYC's proprietary platform technology in the treatment of blinding eye diseases. PYC will meet with the US FDA on June 6, 2025 to align on the pathway to a New Drug Application for VP-001, which if successful, will mark the first approved treatment option for patients with this blinding eye disease of childhood.

Guidance

PYC Therapeutics has not provided any high-importance, price-sensitive forward-looking financial metrics in the announcement.

Outlook

PYC Therapeutics plans to meet with the US FDA on June 6, 2025 to align on the pathway to a New Drug Application for VP-001, which if successful, will mark the first approved treatment option for patients with Retinitis Pigmentosa type 11, a blinding eye disease of childhood.