Phase 1 trial of OLX72021of Treatment of Androgenic Alopecia has been approved for initiation in Australia

27 March 2023 | Monday | News

OliX Pharmaceuticals Receives Regulatory Approval to Commence Phase 1 Clinical Trial of Treatment of Androgenic Alopecia
Image Source : Public Domain

Image Source : Public Domain

  • OliX will evaluate the safety and tolerability of OLX72021 in Phase 1 clinical trial
  • Excellent hair growth effect is observed when used as external solutions
  • OliX also plans to develop OLX72021 as a cosmeceutical for hair loss

OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, announced today that it has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 clinical trial of OLX72021, a treatment for androgenic alopecia, also known as male-pattern baldness.

The trial is a multi-center, randomized, double-blind, placebo-controlled, and single ascending dose Phase 1 study. The primary objective of the study is to evaluate the safety and tolerability of OLX72021 in healthy males with androgenic alopecia.

OLX72021 acts to suppress the hormone activity that causes androgenic alopecia by reducing the expression of the androgen receptor (AR). Since the candidate is rapidly degraded once it is exposed to blood after maintaining high concentration only in subcutaneous hair loss areas, it minimizes side effects of existing hair loss treatments, such as sexual dysfunction or depression. Pre-clinical studies of OLX72021 confirm that the drug effects persist beyond three weeks, which is expected to improve patient compliance.

Chang-Hun Huh, professor of Dermatology at Seoul National University Bundang Hospital, said “This development of OLX72021 in this Phase 1 clinical trial and subsequent trials of OLX72021 have the potential to change the paradigm of hair loss treatment. The existing hair loss treatments are chemically formulated oral medications or topical solutions. There have been many difficulties in the long-term use with these agents for alopecia because of side effects and the inconvenience of daily administration. It is very encouraging that a more targeted treatment like OLX72021 is being developed acting on the stage of siRNA with reduced side effects compared with existing hair loss treatments. I think it is a revolutionary new treatment option for androgenetic alopecia”

The Company has determined that it will develop OLX72021 not only as an RNAi technology-based new drug, but also as a cosmeceutical, which offers consumers accessibility and convenience of use. This is based on excellent hair growth effects observed through application to the skin in addition to injection administration recently observed in rodent hair loss models.

Dong Ki Lee, Ph.D., Founder and Chief Executive Officer of OliX Pharmaceuticals, commented, "With the approval of the clinical trial plan of OLX72021, we now have three RNAi therapeutics programs in the clinical stage. Because the worldwide demand for an effective and safe hair loss treatment is high, we expect high interest in this development program from patients and clinicians. We are also planning to launch hair loss cosmeceuticals in due time for the safety of OLX72021 to be confirmed in this clinical trial. We intend to develop and commercialize an excellent cosmeceutical that will appeal to consumers with satisfying hair loss relief effects.”

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