PYC Therapeutics has concluded the first cohort dosing of healthy volunteers in the Phase Ia single ascending dose (SAD) trial of its drug candidate PYC-003, which targets the underlying cause of polycystic kidney disease (PKD).

The Safety Review Committee (SRC) has reviewed the initial four-week safety data and authorised an increase in dosage for the second cohort.

It approved a dosage escalation from 0.4mg/kg to 1.2mg/kg for the second cohort. The committee is scheduled to meet again in July to review the data from this cohort.

A positive outcome will trigger further dose escalation to 2.4mg/kg in healthy volunteers and initiate dosing at 0.4mg/kg in PKD subjects.

The company has begun dosing the second cohort in the SAD trial's part A and expects to begin part B in the third quarter, pending SRC approval of the safety and tolerability data from the second cohort.

Following parts A and B, the company plans an open-label extension (OLE) trial and a Phase Ib multiple ascending dose (MAD) randomised controlled trial to further assess the drug's optimal dosing regimen, tolerability, efficacy, and safety.

The completion of the Phase Ia/Ib trial is expected to pave the way for a registrational combined Phase II/III trial, which will support a new drug application for the drug.

The primary goal of the Phase Ia SAD trial is to assess the tolerability and safety profile of PYC-003, with a secondary aim to assess its efficacy when the trial extends to PKD subjects in the second half of this year.

PYC Therapeutics leverages its drug delivery platform to improve the precision medicine potency within the RNA therapeutic class. Its drug development programmes focus on monogenic conditions.

"PYC concludes first cohort dosing in trial for kidney disease treatment" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.