PYC Therapeutics Expands Clinical Study for RP11 Drug Candidate
PYC (PYC) Share Update July 2024 Monday 22nd
PYC Therapeutics Expands RP11 Drug Study to Multiple Doses
PYC Therapeutics (ASX: PYC) has announced a significant advancement in its clinical trials for Retinitis Pigmentosa type 11 (RP11), a blinding eye disease. The company has received Institutional Review Board (IRB) approval to extend its ongoing Single Ascending Dose (SAD) study into an open-label 'Part B' where patients will receive multiple doses of its investigational drug candidate.
Instant Summary:
- IRB approval received to extend SAD study into multiple doses.
- Patients will receive either 30 or 75 micrograms of the drug candidate.
- Second dose scheduled approximately 12 weeks after the original dose.
- Third dose scheduled around 8 weeks after the second dose.
- Safety and efficacy data expected before the end of the year.
- Data will inform the design of a registrational trial set to commence in 2025.
Study Extension Details
PYC Therapeutics, a clinical-stage biotechnology company, is developing a first-in-class drug candidate for patients with Retinitis Pigmentosa type 11 (RP11). The company has received IRB approval to extend its ongoing Single Ascending Dose (SAD) study into an open-label 'Part B' where patients will receive multiple doses of the drug candidate.
The extension will allow patients who have received a single dose in the existing SAD study to rollover into Part B, where they will receive either 30 micrograms or 75 micrograms of the drug candidate in the previously treated eye. The second dose is scheduled to be administered approximately 12 weeks after the original dose, followed by a third dose around 8 weeks after the second dose.
Expected Outcomes
Patients will be assessed on both safety and efficacy endpoints throughout the study. The data from Part B of the SAD, along with data from the ongoing Multiple Ascending Dose (MAD) study, is expected to be available before the end of the year. This data will be crucial in informing the design of a registrational trial required to support a New Drug Application (NDA) for the drug candidate, which is anticipated to commence in 2025.
About RP11 and VP-001
Retinitis Pigmentosa type 11 (RP11) is a genetic blinding disease affecting 1 in every 100,000 people. It is caused by a mutation in one copy of the PRPF31 gene, leading to a protein insufficiency in photoreceptor and Retinal Pigment Epithelial (RPE) cells. PYC's drug candidate, VP-001, aims to increase the expression of PRPF31 back to wild-type levels in RP11 patient-derived retinal organoids and iPSC-RPE.
VP-001 is the first drug candidate to progress into human trials for RP11 and has been granted fast track status by the FDA. The addressable market for RP11 is estimated to be over $1 billion annually.
Pre-Clinical Data
Pre-clinical data has shown that VP-001 achieves high concentration in the Non-Human Primate (NHP) retina and is safe and well-tolerated. The drug candidate has also shown effectiveness in patient-derived models, further supporting its potential as a treatment for RP11.
The extension of the SAD study to include multiple doses is a significant step forward for PYC Therapeutics. This will likely have a positive impact on the company's stock as it demonstrates progress in the clinical development of VP-001. The anticipated data read-outs before the end of the year will be crucial in maintaining investor confidence and could potentially lead to an increase in stock value if the results are favorable.
Investor Reaction:
Analysts have noted that the IRB approval is a positive development for PYC Therapeutics. Investors are optimistic about the potential of VP-001 to address the unmet need in RP11 treatment. The upcoming data read-outs are highly anticipated and could significantly influence investor sentiment.
Conclusion:
Investors should keep a close eye on the upcoming data read-outs from the SAD and MAD studies. These results will be pivotal in determining the future direction of PYC Therapeutics' clinical development program for VP-001. The company's strategic advancements in extending the study to multiple doses highlight its commitment to addressing the unmet needs of patients with RP11.