Histogen has announced the 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.
HST-001, or Hair Stimulating Complex (HSC), is an injectable formulation of naturally secreted 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. The HST-001 Phase 1a/2b trial is a blind, randomized, placebo-controlled, single site study of 36 subjects with male pattern hair loss using a 2:1 randomization of HST-001 to placebo. The study was designed to evaluate the safety and efficacy of HST-001 including total hair count, non-vellus hair count and hair density, measured by Canfield macrophotography. At each treatment timepoint (weeks 0, 6 and 12 weeks), subjects receive 10 injections in the temporal recession region and five in each vortex scalp region.
Histogen is a clinical-stage therapeutics company that focuses on developing potential restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function.
“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, president and CEO of Histogen. “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.”