HST 001 – Hair Stimulating Complex (HSC)

Histogen’s lead product application is a Hair Stimulating Complex (HSC), intended to be a physician-administered therapeutic for alopecia (hair loss). HSC is anticipated to be a 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. Follistatin in particular has been linked to hair follicle stem cell proliferation.

Clinical Development

Histogen is advancing its HSC program into a Phase 1b/2a Clinical Trial (US IND 108935) to evaluate the safety and efficacy of HSC in male pattern hair loss. Three previous Company-sponsored proof-of-concept clinical trials have been completed in male pattern and female diffuse hair loss. In one trial, 84.6% of men treated showed new terminal hair growth and treatment was well tolerated.

In the second clinical trial, statistically significant and cosmetically relevant improvements were observed in total hair count, terminal hairs and hair thickness at 12 weeks, with hair growth parameters remaining substantially above baseline one year post-treatment.

Market

The hair loss market is both large and underserved. Histogen believes this is largely due to the ineffectiveness of currently available options, and the hesitation of many affected to seek invasive surgical treatments.

Patients seek a safe, minimally-invasive treatment to achieve cosmetically relevant new hair growth. The development of HSC has the potential to expand the hair restoration market by offering a successful option to those that currently have none, and a more effective option to anyone presently using or considering Rogaine or Propecia.