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- Phase III trial to enroll 420 men across up to 10 clinical sites in Canada
- First patient has now been dosed in the Company’s Phase III trial evaluating TH07
- TH07 is a patented prescription triple-combination topical therapy targeting multiple pathways involved in hair loss
- Androgenic alopecia affects hundreds of millions of men worldwide
Triple Hair Group Inc. (“Triple Hair” or the “Company”), a company specializing in the development of innovative treatments for androgenic alopecia (pattern baldness), today announced that the first patient has been dosed in its Phase III clinical trial in Canada evaluating TH07, the Company’s patented prescription topical treatment for male pattern hair loss.
The Phase III clinical trial (NCT07435012) is designed to evaluate the safety and efficacy of TH07 in men with androgenic alopecia. TH07 is a patented prescription topical spray formulation that combines three active ingredients, minoxidil, finasteride, and latanoprost, each of which has demonstrated relevance to hair-growth biology through approved use and published scientific literature.
This 24-week, randomized, double-blind, placebo-controlled, multicentre study is expected to enroll 420 male participants with moderate to moderately advanced androgenic alopecia across up to 10 clinical sites in Canada. Additional information regarding the trial and enrollment criteria is available at: https://triplehair.ca/clinical-trials.
“The dosing of the first patient in our Phase III trial marks an important milestone for Triple Hair and the continued advancement of TH07,” said Jean-Philippe Gravel, President and CEO of Triple Hair. ” Androgenic alopecia affects hundreds of millions of men globally and remains an area of significant unmet need, with limited effective treatment options available. We believe TH07’s differentiated multi-mechanism approach has the potential to offer a meaningful new prescription treatment option in a large and underserved market, and we look forward to advancing the program and generating robust clinical data through this pivotal study.”
“Male pattern baldness remains one of the most common dermatological conditions affecting men,” added Dr. Martin Braun, Principal Medical Investigator of Triple Hair’s Phase III trial. “This study is expected to provide important data on whether a multi-mechanism topical therapy such as TH07 can improve treatment outcomes for patients.”
About TH07
TH07 is a patented prescription triple-combination topical therapy that combines minoxidil, finasteride and latanoprost, three pharmacologically active agents that target distinct biological pathways involved in androgenic alopecia.
The therapy is designed to address multiple mechanisms associated with hair loss by:
- stimulating hair follicle activity,
- reducing androgen-mediated follicle miniaturization, and
- supporting prolonged hair growth cycles.
By integrating these complementary mechanisms in a single topical formulation, TH07 is designed to simultaneously target several key drivers of hair loss.
TH07 has previously demonstrated encouraging results in earlier clinical studies, where 82% of participants experienced positive outcomes ranging from moderate to dense hair regrowth, supporting its continued development in Phase III evaluation.
About Triple Hair
Triple Hair Group Inc. is a Canadian biotechnology company focused on the development of innovative therapies for androgenic alopecia, a condition affecting hundreds of millions of men and women worldwide.
The global hair-loss treatment market was valued at approximately US$8.8 billion in 2023 and is projected to reach over US$16 billion by 2030, reflecting the significant demand for safe and effective treatment options.
Triple Hair’s lead product candidate, TH07, is a patented prescription topical therapy currently in Phase III clinical development.
For more information, visit the Company’s website, at www.triplehair.ca/investors.
Contact:
Triple Hair Group
Jean-Philippe Gravel
President and CEO