PYC Therapeutics is set to begin Part B in its single ascending dose (SAD) study of the drug candidate, PYC-003, for polycystic kidney disease (PKD) patients.
The Safety Review Committee (SRC) has reviewed the four-week safety data from the first two cohorts of Part A and granted approval to escalate to cohort 3 dosing carried out in healthy volunteers.
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PYC Therapeutics is on track to move into repeat-dose trials in PKD subjects in the fourth quarter of this year.
It has three clinical-stage drug development programmes underway, including PYC-003.
The dosing of patients with PKD is set to begin this month.
The SAD study’s parts A and B will pave the way for an open-label multiple ascending dose (MAD) trial, which will determine the optimal dosing regimen of the drug candidate.
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By GlobalDataThis trial will run concurrently with a Phase Ib randomised controlled trial to assess the tolerability, efficacy, and safety of the candidate.
The completion of the Phase Ia/Ib trial is expected to pave the way to a registrational combined Phase II/III trial.
This trial aims to support a new drug application for the candidate. The primary objective of the ongoing Phase Ia SAD trial will evaluate the tolerability and safety profile of the candidate, with a secondary objective assessing its efficacy in PKD patients.
PYC Therapeutics CEO Dr Rohan Hockings said: “The dose administered in cohort 2 is expected to be at the upper end of the efficacy range in humans based on the pre-clinical data.
“Establishing safety/tolerability at a dose that we are happy to progress into pivotal studies is an important milestone.”
The company develops a new generation of RNA therapies to help individuals with genetic conditions.
It leverages its drug delivery platform to improve the precision medicines within the RNA therapeutic class. Its drug development programmes focus on monogenic diseases.
