Trial for Androgenic Alopecia

Histogen Announces Completion of Patient Enrollment for its HST 001 Phase 1b/2a Trial for Androgenic Alopecia

Histogen a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, today announced the completion of patient enrollment ahead of schedule in its Phase 1b/2a clinical trial of HST 001, designed to assess the safety, tolerability and indicators of efficacy of HST 001 for the treatment of androgenic alopecia in men.

“We are pleased to have accomplished this clinical milestone with HST 001 and we look forward to completing the treatment phase of the study and releasing top-line data in the fourth quarter of this year,” said Richard W. Pascoe, Histogen’s President and CEO. “The on-time achievement of this milestone demonstrates our ability to execute on the clinical development plans for HST 001, which has the potential to stimulate new long-lasting hair growth in contrast to existing therapies that focus on reducing hair loss.”

About the HST 001 Phase 1a/2b Trial
This blinded, randomized, placebo-controlled, single-site study has enrolled 36 subjects with male pattern hair loss using a 2:1 randomization of 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.

At each treatment time point (Weeks 0, 6, and 12), subjects will receive a total of 20 injections divided between the temporal recession and vertex scalp areas, the most common regions of hair loss in men with androgenic alopecia.

Primary endpoints will be assessed at Week 18 and secondary endpoints at both Week 18 and Week 26. 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. We expect HSC to be a relatively safe, minimally invasive treatment that promotes new hair growth where existing treatments only reduce hair loss.

HSC is designed 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 Completion of Patient Enrollment for its HST 001 Phase 1b/2a Trial for Androgenic Alopecia in MenTop Line Results Expected Q4’2020

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