OliX announced on August 4 that it has completed patient dosing in the Australian Phase 1b clinical trial for OLX104C (compound name: OLX72021), an investigational RNA interference (RNAi) therapy for male-pattern hair loss. OliX is a South Korean biotechnology company specializing in therapeutics that utilize RNAi technology to suppress disease-causing genes.
The completion of Phase 1b dosing comes approximately seven months after the first patient was dosed in the combined Phase 1b/2a trial on December 19 of last year. The company is currently conducting follow-up monitoring for the final patient, which is expected to conclude in mid-to-late August. Following data analysis, OliX plans to advance directly into Phase 2a to formally evaluate the drug's therapeutic efficacy.
The Phase 1b/2a study is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and efficacy of OLX104C in men with androgenetic alopecia. In the Phase 1b portion, researchers assessed safety across multiple ascending dose groups while monitoring potential impacts on sexual function.
Targeting the Root Cause of Hair Loss Directly in the Scalp
OLX104C works by reducing the expression of the androgen receptor (AR), a primary factor in androgenetic alopecia. In male-pattern hair loss, dihydrotestosterone (DHT) binds to AR in hair follicle cells, causing progressive hair thinning. While traditional oral hair loss medications act systemically by inhibiting DHT production throughout the body, OLX104C is administered locally to the scalp to lower AR expression directly in hair tissues. This targeted approach is designed to minimize systemic exposure side effects and reduce the dosing burden of daily medication.
Building on favorable safety and tolerability results from an earlier Australian Phase 1a single-dose study, the Phase 1b trial expanded to evaluate safety under repeated dosing. The upcoming Phase 2a trial will compare three different dosage levels against a placebo to verify human proof of concept (PoC) and measure hair-loss improvement following repeated intradermal injections.
"As soon as follow-up monitoring for the final patient concludes in mid-to-late August, we will analyze the data and transition swiftly into Phase 2a," said Lee Dong-ki, CEO of OliX. "Phase 2a will allow us to formally verify the in-human clinical efficacy of OLX104C with repeated administration."
