Histogen Announces Completion of Dosing Milestone in its 1b/2a Trial for Androgenic Alopecia in Men

Top Line Results Remain on Track for Q4’2020

SAN DIEGO, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO),  a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today announced completion of patient dosing for the week 6 treatment timepoint 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 the second of three treatment timepoints in our HST-001 trial and we remain on track to announce top line data results in the fourth quarter of this year,” said Richard W. Pascoe, Histogen’s President and CEO.  “HST-001, if approved, could be a first-in-class product given its 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 timepoint (Weeks 0, 6 and 12), subjects will receive a total of 20 injections, 10 in the temporal recession region and 5 in each vertex scalp region, the most common areas of hair loss in men with androgenic alopecia.  Primary and secondary endpoints will be assessed at Week 18.  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 signaling stem cells in the body and have been shown to be important in hair formation and the stimulation of resting hair follicles.