Hoth Therapeutics (HOTH) announced that its product, HT-003, has yielded positive results in an in vivo acne therapeutic model. The model showed that HT-003 reduces the expression of toll-like receptor 2 (TLR2), which happens to be considered one of the most critical pathways for the acne pathophysiology.
The study demonstrated that HT-003 reduces the expression of numerous cytokines critical for acne pathophysiology that are relevant therapeutic markers for other inflammatory-driven skin diseases.
Hoth Therapeutics HT-003
HT-003 is a group of retinoic acid metabolism blocking agents (RAMBA). This group prevents the breakdown of retinoic acid, which acts as an anti-inflammatory agent.
In the study, mouse skin was topically pre-treated with RAMBA or a non-clinical vehicle for two days. Then, the skin was intradermally injected with peptidoglycan (PGN), which causes acne-like inflammation.
The models demonstrated that PGN-induction of TLR2 and a broad list of inflammatory cytokines were inhibited in the skin that was pre-treated with RAMBA.
Dr. Jonathan Zippin, M.D., Ph.D., FAAD, Associate Professor of Dermatology at Weill Cornell Medicine and Hoth Therapeutics Senior Scientific Advisor, said, “The results of this study are extremely promising and suggest that this drug could both treat acne and may actually help prevent it. “The data also suggest that the HT-003 compounds have the potential for the treatment of numerous inflammatory skin diseases.”
In addition to the dermatologic application, Hoth Therapeutics is exploring the potential application of HT-003 assets in inflammatory bowel disorders (IBDs).
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage company focused on helping patients suffering from conditions including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell-derived cancers & anaphylaxis and pneumonia. Hoth entered into two different agreements to further the development of two therapeutic prospects to prevent or treat COVID-19.
HOTH Therapeutics Stock
|Market Cap.||$33.79 million|
Kintor Pharmaceutical Ltd Treating Androgenetic Alopecia and Acne
Kintor Pharmaceutical Limited (9939:HK) announced that the U.S. FDA has cleared an Investigational New Drug (IND) application for its novel drug GT20029 for treating androgenetic alopecia (AGA) and acne subjects.
GT20029 is the first topical Proteolysis Targeting Chimera (PROTAC) compound to enter clinical stage. Following the China Center for Drug Evaluation (CDE) IND approval for GT20029’s clinical study in April 2021, the clinical study in the US is about to start.
From Kintor Pharmaceutical Ltd
Dr. Tong Youzhi, the founder, Chairman, and CEO of Kintor Pharmaceutical commented, “Kintor started to build up PROTAC platform in 2018, based on which Kintor developed AR-PROTAC (GT20029), an innovative topical drug. This clearance is another international clinical trial clearance obtained by the company after FDA has just greenlighted pyrilutamide (KX-826)’s phase II clinical trial for the treatment of AGA, further expanding the international distribution of Kintor’s innovative drug pipelines. Both indications of androgenetic alopecia and acne have huge unmet clinical needs, and we hope to accelerate the clinical progress to provide safe and effective treatments for people who suffer from androgenetic alopecia and acne.”
The trial is a randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study in subjects to evaluate the safety, tolerability and pharmacokinetics of GT20029 following topical single and multiple ascending dose administration.
- The excessive activation of systemic and local androgen receptor pathways is an important link in the pathogenesis of androgenetic alopecia and acne.
- GT20029 can effectively block the androgen receptor pathway and physiological function by degrading the AR protein.
- The preclinical studies demonstrate that the efficacy of GT20029 appears superior to other small molecule AR inhibitors.
- Topical GT20029 has also been shown to avoid systemic exposure and many of the side effects of oral androgen signaling pathway inhibitors.
- In China, the CDE accepted GT20029’s phase I clinical trial in April 2021. The first patient dosing in China is expected this month.
The FDA Greenlighted Phase II Trial for Pyrilutamide for Androgenetic Alopecia
Kintor Pharmaceutical Ltd has also announced that the U.S. FDA has greenlighted pyrilutamide (KX-826)’s phase II clinical trial for the treatment of androgenetic alopecia (AGA).
The primary endpoint for the trial is the change from baseline in non-vellus Target Area Hair Counts (TAHC) at Week 24 in comparison to vehicle.
Commenting on the news, Dr. Tong Youzhi, said, “We are delighted to receive the green light from the FDA for this trial, as Kintor’s strategy is to conduct trials in both China and the US. Patient dosing of pyrilutamide’s phase II clinical trial in China for AGA has been completed, the data of which is expected to read out in the third quarter of 2021. Androgenetic alopecia affects hundreds of millions of men and women around the world, accounting for approximately 90% of patients with hair loss. We hope to demonstrate pyrilutamide can become a treatment for patients with this condition. ”
Pyrilutamide – a topical androgen receptor antagonist with a specific target, can inhibit the combination of androgen receptor and androgen in hair follicle sebaceous glands, thereby treating androgenetic alopecia and acne.
Kintor Pharmaceutical Ltd is developing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast, and liver cancer, alopecia, and acne.
Kintor Pharmaceutical Ltd
|Market Cap.||$22 million|
With the current biological revolutionary information, one can expect that the biotechnology firms’ researchers to come up with treatments for acne and alopecia, among other complex inflammatory diseases. The encouraging news about promising acne treatments brings hope to millions of children and teenagers who live with the nightmare of acne, in addition to the millions of men and women who have lost their hair and have yet to find safe and effective treatments.
We hope that Hoth Therapeutics’ trials confirm its successful early preclinical results in treating acne. We also hope that Kintor Pharmaceutical Ltd’s new FDA greenlit trials would prove the firm’s early clinical trials. If that happens, it will be extremely rewarding for both firms and millions of sufferers.
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