Trial of HST 001 for Androgenic Alopecia

Histogen Announces First Patient Dosed in Phase 1b/2a Trial of HST 001 for Androgenic Alopecia

Histogen Inc, a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today the enrollment of the first patient in its Phase 1b/2a clinical trial of HST 001, the Company’s lead therapeutic candidate for the treatment of androgenic alopecia in men.

This blinded, randomized, placebo-controlled, single-site study will enrol 36 subjects with male pattern hair loss using a 2:1 randomization HST 001 to placebo. It is designed to assess the safety and tolerability of HST 001, as well as indicators of efficacy including non-vellus hair count, total hair count, and hair thickness density as measured by Canfield macrophotography.

“The initiation of this clinical trial is a critical milestone for Histogen following the completion of our merger and listing on the Nasdaq Capital Market last week,” said Richard Pascoe, Chief Executive Officer of Histogen. “HST 001 is a potentially transformative approach to treating androgenic alopecia given that existing therapies focus on reducing hair loss, while HST 001 has the potential to stimulate new long-lasting hair growth.”

Building on prior clinical experience with HST 001, the Phase 1b/2a study will be the first company-sponsored trial to include a third dosing time point, with dosing taking place at week 0, week 6 and week 12.

At each treatment timepoint, subjects will receive 20 injections focused on temporal recession and vertex scalp areas, the most common regions of hair loss in men with androgenic alopecia.

Top-line data is anticipated to be available in the fourth quarter of 2020.

About HST 001

HST 001, or Hair Stimulating Complex (HSC), is intended to be a physician-administered therapeutic for hair loss. HSC is anticipated to be a relatively safe, minimally invasive treatment that promotes new hair growth where existing treatments only reduce hair loss.

HSC is manufactured to enrich for growth factors including KGF, VEGF, and follistatin, which are involved in signalling stem cells in the body and have been shown to be important in hair formation and the stimulation of resting hair follicles.

About Histogen

Histogen is a regenerative medicine company developing patented technologies that replace and regenerates tissues in the body. The company’s innovative technology platform utilizes cell-conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells, developing therapeutic products that address underserved, multi-billion US dollar global markets. For more information, please visit www.histogen.com.

Histogen Announces First Patient Dosed in Phase 1b/2a Trial of HST 001 for Androgenic Alopecia

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