Kintor Announces New Advanced Androgen Receptor Drug GT20029
China Trial Enrolls 180 Patients To Complete Enrollment (8/22/23)
On August 22, 2023, Kintor Pharmaceutical announced the completion of patient enrollment in a phase 2 trial in China for GT20029. This means all of the patients needed to complete the study have been enrolled, and will undergo their dosing schedule over the next 12 weeks. The trial of GT20029, which is an androgen receptor degrader drug, is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of GT20029 in treating male AGA, and to determine the recommended dosage for the phase 3 clinical trial.
Dr. Youzhi Tong, CEO of Kintor Pharmaceutical, said “We expect to release the top-line data of the Phase II clinical trial in the first quarter of 2024, and look forward to collecting more efficacy and safety data of GT20029 in this trial.”
US GT20029 Trial Begins: Update (2/3/22)
Steady and exciting progress continues for Kintor Pharmaceutical. Early this morning, apress releasewas issued by Kintor announcing the dosing of the first subject in a phase 1 clinical trial for its innovative drug GT20029. See below for description of GT20029. The drug will be delivered in a topical gel form and is being trialed against androgenetic alopecia and acne vulgaris. Dr. Youzhi Tong, CEO of Kintor Pharma, shared these words in the release: “The start of this US clinical trial represents a significant milestone for Kintor, as it demonstrates the beginning of the international development of the company’s fourth innovative drug. In preclinical studies, we found that GT20029 can effectively block the androgen receptor pathway and its physiological function by degrading the AR protein. By limiting skin penetration, GT20029 inhibits local androgenic effects in peripheral skin tissues and so achieve good safety.“
Bonus news: AClinicalTrials.govpage for a US phase 2 trial of Kintor’s other drug pyrilutamide has just been published. It appears that the trial is set to begin immediately. Three cohorts will test a 2.5 dose, a 5mg once and twice daily.
FDA Grants IND For Advanced GT20029 PROTAC Drug: Update (7/13/21)
Kintor is on a roll. Just days after we received the update that the FDA approved a phase 2 study of pyrilutamide in the US, we now get news that Kintor has also received an IND for their new potential breakthrough drug GT20029. Even better, thepress releasestates that Kintor received approval for a phase 1 trial of GT20029 in China back in April 2021 and the first patient dosing is expected in July 2021! To review the many theorized advantages of GT20029, which is a PROTAC drug, see the article below.
There is no set date for the US trial of GT20029 at this time, but according to today’s release,Kintor has plans to complete “a randomised, double-blind, vehicle-controlled, parallel-group, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of GT20029 following topical single and multiple ascending dose administration.“
中国Kintor制药宣布a press release today that the company is bringing yet another androgen receptor-based drug into clinical trials for the treatment of androgenic alopecia.
Androgen Receptor Degrader GT20029
Those who have been following along over the past year must be familiar withpyrilutamide, a topical androgen receptor-antagonist drug which is being trialed by Kintor in China and the USA for pattern hair loss. Pyrilutamide entered into a phase 2 trial in China at the end of 2020 and completed a phase 1 trial in USA last year for androgenic alopecia. The program is quite ambitious as Kintor has formally announced their plans to enter a phase 3 trial for pyrilutamide for AGA by the end of 2021, but it appears they’re not done yet either.
On February 2, 2021, Kintor announced that an investigational new drug application (IND) for the drug GT20029 has been approved by the NMPA of China (equivalent to the FDA) for the indications of androgenic alopecia and acne vulgaris. GT20029 is a new advanced form of an anti-androgen called a PROTAC which stands for proteolysis targeting chimera. It will be developed alongside pyrilutamide in the company’s pipeline.
A simpledefinitionof a PROTAC: “a heterobifunctional small molecule composed of two active domains and a linker capable of removing specific unwanted proteins.” Kintor states that GT20029 was developed through the company’s in-house PROTAC platform. Here are some explanatory statements by Kintor in their latestpress release:
“GT20029 is an AR degrader that degrades the AR protein. The mechanism of action of GT20029is to recruit the AR protein to the E3 ubiquitin ligase for degradation. It acts on the local tissues ofthe peripheral skin and local hair follicle sebaceous glands, which reduces the sensitivity of AR toandrogens without systemic exposure to the drug.
“As each PROTAC molecule can degrade multiple AR proteins, drugs based on PROTAC can achieve efficacy with a low dosage. In addition, as long as there are a small amount of PROTAC molecules in the cells, the efficacy of the drugs can be maintained, which can significantly reduce the dosing frequency as compared to other small molecule drugs.”
“According to animal experiments, the efficacy of GT20029 is superior to other small molecule AR inhibitors. In addition, GT20029 will not cause excessive drug accumulation and notable side effects. While achieving efficacy, GT20029 can effectively avoid systemic exposure to mitigate or avoid the side effects of the oral androgen signaling pathway inhibitors.”
Sounds good, yeah? This is the kind of drug evolution that most of us have been hoping for since finasteride became mainstream decades ago. It sounds like Kintor is getting closer to the ideal anti-androgen for hair regrowth and hair loss prevention (if all goes well). Kintor also states that they believe GT20029 is the first topical PROTAC drug which has entered the clinical trial stage anywhere in the world. An IND is expected to be filed soon in the USA for GT20029 as well.
What does everyone think of Kintor’s progress and efforts to create new innovative drugs for preserving hair growth? Comment below.