[E-Daily Reporter KIM SAE-MI ] Olix Pharmaceuticals, Inc.(226950)has completed patient follow-up for the Australian Phase 1b clinical trial of its male pattern hair loss treatment “OLX104C (OLX72021).” The company is analyzing the clinical data while preparing for subsequent clinical trials, with the goal of administering the first dose to a patient in the Phase 2a trial by the end of the year.

Olix Pharmaceuticals, Inc. announced on the 24th that it had completed follow-up observations for the last patient in the Australian Phase 1b clinical trial of OLX104C on the 17th.

Olix Pharmaceuticals, Inc. began dosing the first patient in the OLX104C Phase 1b/2a clinical trial last December. Following the completion of dosing for all Phase 1b patients last month, the company has now concluded the patient follow-up process for the Phase 1b trial by completing the follow-up for the last patient.

OLX104C is a treatment for male pattern hair loss currently under development based on Olix Pharmaceuticals, Inc.’s RNA interference (RNAi) technology. The Phase 1b/2a clinical trial is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of OLX104C in men with androgenetic alopecia.

In this Phase 1b trial, safety and tolerability were evaluated through repeated administration using a multiple-dose escalation protocol across two dose groups. The potential impact of the treatment on sexual function was also assessed.

Previously, Olix Pharmaceuticals, Inc. evaluated the safety and tolerability of a single dose of OLX104C in a Phase 1a clinical trial conducted in Australia. Subsequently, the Phase 1b trial expanded the scope to multiple doses, focusing on confirming safety following repeated administration.

While analyzing the Phase 1b data, the company plans to simultaneously prepare for the subsequent Phase 2a trial, aiming to begin the trial and administer the first dose to patients within the year. In the Phase 2a trial, the company plans to evaluate the proof of concept (PoC) in humans by comparing three dose groups with a placebo group to determine whether repeated intradermal injections of OLX104C produce actual therapeutic effects in patients with male pattern hair loss.

Accordingly, this trial is expected to mark the stage in the OLX104C development process where therapeutic efficacy is formally verified in actual patients.

An Olix Pharmaceuticals, Inc. official stated, “OLX104C has completed both patient dosing and follow-up observations for the Phase 1b clinical trial in accordance with the originally planned schedule,” adding, “We are preparing to proceed with subsequent clinical trials without delay and are advancing development with the goal of entering Phase 2a and administering the first dose to a patient within this year.”