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.
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