OliX Pharmaceuticals Administers First Patient in Phase 1 Clinical Study of RNAi Therapeutic OLX72021 for Androgenic Alopecia

SUWON, South Korea, Jun. 13, 2023 - OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, announced today that the first patient has been administered on June 5, in a Phase 1 clinical trial, evaluating OLX72021, an investigational RNAi therapeutic intended for the treatment of androgenic alopecia, also known as male-pattern baldness.

In March, OliX received approval for the Phase 1 clinical study of OLX72021 from Bellberry Human Research Ethics Committee (Bellberry HREC) in Australia and began enrolling patients. Administration of the treatment to the first patient was conducted at a designated clinical study organization in Australia.

The primary objective of the clinical study is to evaluate the safety, tolerability, and pharmacokinetics of OLX72021 in single intradermal injection. Dividing up to 30 healthy males with androgenic alopecia into 5 cohorts, the clinical study is conducted in the way of follow-up monitoring for 8 weeks after intradermal injection of OLX72021 in different dosages or placebo in 6 areas of alopecia near the crown area of the patients.

OLX72021 acts to suppress the hormone activity that causes androgenic alopecia by reducing the expression of the androgen receptor (AR). As the Company identified long-term efficacy of OLX72021 in pre-clinical studies, OLX72021 is expected to minimize the inconvenience of existing hair loss treatments that require frequent injection or administration. In addition, since OLX72021 is to be topically injected into the scalp and rapidly degraded upon exposure to the blood after maintaining high concentration only in subcutaneous hair loss areas, it could overcome side effects by their systemic exposure, such as sexual dysfunction or depression.

In 2021, OliX acquired a patent for OLX72021in the U.S. and published a pre-clinical study paper in an international journal “Molecular Pharmaceutics”, in 2022. Apart from the new drug development track, the Company announced its plan to launch hair loss cosmeceuticals in due time when the safety of OLX72021in human bodies is confirmed in Phase 1 clinical trial in Australia.

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