The Phase I clinical trial of PIONEER PHARMACEUTICAL'S AR-PROTAC (GT20029) completed the enrollment of subjects for dosing

Pioneer Pharmaceutical (stock code: 9939.
HK), a biopharmaceutical company focused on the development and industrialization of potential first-in-class and best-in-class innovative drugs, announced on October 27 that its self-developed novel protein-degrading chimera (PROTAC) compound GT20029 targeting androgen receptors (AR) in the US phase I clinical trial for the treatment of androgenetic alopecia and acne has completed the enrollment and administration
of all 120 subjects on October 25, 2022.
GT20029 is based on PROTAC technology and is the world's first topical PROTAC compound
to enter the clinical stage.

The Phase I clinical trial is a randomized, double-blind, placebo-controlled, parallel-design, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of GT20029 in single-dose escalation and multiple dose escalation in healthy subjects and in subjects with androgenetic alopecia or acne
.

Preclinical studies have shown that GT20029 can effectively block the atrophy and miniaturization of hair follicles caused by the activation of AR signaling pathway by degrading androgen receptor proteins, and inhibit hair thinning, softening and shedding
.
At the same time, GT20029 only produces local efficacy, reducing systemic drug exposure by limiting skin penetration for better safety
.

Dr.
Youzhi Tong, Founder, Chairman and CEO of Pioneer Pharmaceutical, said: "We are very pleased to see the enrollment and administration of GT20029 Phase I clinical trial in the United States, as the first company in the world to develop topical PROTAC, we have been actively exploring innovative drug strategies
to apply PROTAC to clinical topical therapy.
GT20029, as a PROTAC compound, is optimized compared with Frithane in terms of frequency and efficacy to meet the needs
of patients with different types of hair loss and acne.
Hair loss afflicts about 1.
6 billion people around the world, acne affects about 720 million people worldwide, in the face of the huge unmet clinical needs of hair loss and acne, we will accelerate the clinical process of GT20029 and Foritaen, and look forward to providing safe and effective innovative therapies
for the global androgenetic alopecia and acne patient population as soon as possible.
”

About GT20029

GT20029 is a topical compound
developed by Pioneer Pharmaceuticals based on PROTAC technology.
In April 2021, China's National Medical Products Administration (NMPA) approved GT20029 for clinical trials
.
In August 2022, the GT20029 China Phase I clinical trial completed the enrollment of subjects
.
In July 2021, GT20029 received Phase I clinical trial approval
from the U.
S.
Food and Drug Administration (FDA).
In February 2022, the first subject was dosed
in the GT20029 US phase I clinical trial.