Histogen Stops HST 001 Development After Trial Failure, Shifts Focus On Programs For Orthopedic Indications

Histogen Inc HSTO has decided to suspend the development of the HST 001 program after taking into consideration the results from the Phase 1b/2a trial in androgenic alopecia (male pattern baldness).
It said while HST 001 demonstrated a favorable safety and tolerability profile, the development resources required to potentially achieve an acceptable efficacy threshold are substantial in terms of cost and time.
In February, HST-001 did not achieve statistical significance at week 26 compared to the placebo on change from baseline in total hairs in the target area.
The company said it is on track to initiate Phase 1/2 trial for HST 003 this month for cartilage regeneration in the knee.
The company also initiated an investigational new drug application (IND) enabling activities for HST 004, a CCM solution intended to be administered through an intradiscal injection for spinal disc repair. The filing of an IND is expected in the second half of 2022.
Last month, the company and its partner Amerimmune completed enrollment of the Phase 1 study of emricasan to treat mild-symptomatic COVID-19 patients.
13 patients have been enrolled versus the initially targeted 40 patients.
To date, there have been no reports of serious adverse events, and top-line safety, biomarker, and patient-reported outcomes data are expected to be available in June.
Price Action: HSTO shares down 2.9% at $0.99 during the market session on the last check Thursday.