ASX:PYC

3 stories mentioning ASX:PYCUpdated 40d ago

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PYC Therapeutics Starts Phase 1b Multiple Ascending Dose Study in Polycystic Kidney Disease; Shares Up Nearly 5%

PYC Therapeutics (ASX:PYC) started a phase 1b multiple ascending dose study in patients with polycystic kidney disease, with the dosing of the first patient with its drug candidate, PYC-003, completed, according to a Thursday Australian bourse filing.The study will seek to determine the safety/tolerability profile and optimal repeat dosing regimen of PYC-003 before a proposed transition to a registrational combined phase 2/3 trial.It will also measure other endpoints, including urinary PC1 protein levels, total kidney volume on magnetic resonance imaging, and the estimated glomerular filtration rate, per the filing.The company's shares gained nearly 5% in recent Thursday trade.

ASX:PYC

Asia54d ago

PYC Therapeutics' Blinding Eye Disease Treatment Candidate Gets Orphan Drug Designation in Europe

PYC Therapeutics (ASX:PYC) said its VP-001 drug candidate for blinding eye disease Retinitis Pigmentosa type 11 received orphan drug designation from the European Medicines Agency, according to a Monday filing with the Australian bourse.The benefits of the designation include scientific advice and other assistance from the European regulator, lower regulatory fees for the drug candidate's review, and 10 years of exclusivity in the European market once approved.VP-001 previously obtained orphan drug designation and fast track status from the US Food and Drug Administration, PYC Therapeutics said.

ASX:PYC

Asia66d ago

PYC Therapeutics Advances Optic Atrophy Drug to Multiple-Dose Study After Safety Clearance; Shares Up 7%

PYC Therapeutics (ASX:PYC) has been cleared by the safety review committee to advance PYC-001 candidate into a multiple ascending dose study in patients with autosomal dominant optic atrophy (ADOA), following positive four-week safety and tolerability results from the 60 microgram single ascending dose trial, according to a Wednesday filing with the Australian bourse.The company is currently assessing repeat dosing in ADOA patients to evaluate safety and preliminary efficacy, aiming to establish clinical proof of concept before initiating a global registrational trial to support a new drug application, the filing said.The results from the ongoing phase one and two multiple ascending dose study will be presented throughout 2026 and 2027, the filing added.The company's shares rose 7% in recent Wednesday trade.

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