Benzinga | Jun 22, 2021 08:01AM EDT

Histogen Amerimmune Report Top-Line Study Results From Phase 1 Study Of Emricasan In Mild Symptomatic COVID-19 Patients: Emricansan Found To Be Safe, Well Tolerated With No Serious Adverse Events

Emricasan Found to be Safe and Well Tolerated with No Serious Adverse Events

Patients Completing Treatment with Emricasan had a Complete Resolution of the Symptoms Most Commonly Associated in Mild COVID-19 At Day 7 Continuing to Day 45

SAN DIEGO, June 22, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), and its partner Amerimmune LLC, today announced top line results from its Phase 1 study of emricasan in mild symptomatic COVID-19 patients to assess safety, tolerability, and preliminary efficacy. The study demonstrated that emricasan was safe and well tolerated during the 14 days of dosing and at the day 45 follow-up, as compared to placebo with no reports of serious adverse events. Patients who completed treatment with emricasan had a complete resolution of the symptoms most commonly associated in mild COVID-19, such as cough, headache and fatigue at day 7 and continued through day 45. Patients in the placebo arm who completed the study did not experience COVID-19 symptom resolution at any time point out to day 45.

In addition, a number of very important observations were made related to clinical outcomes, laboratory findings and drug target related biomarkers. These improvements were seen in all subjects in the active drug group that showed decreases in caspase biomarkers, whereas patients in placebo group continued to have COVID-19 related symptoms and laboratory findings.

"The data from the Phase 1 study of emricasan administered in the outpatient setting underscores its safety and potential clinical benefit in the treatment of mild symptomatic patients," said Raavi Gupta, M.D. Associate Professor and the Principal Investigator at SUNY Downstate Health Sciences University.

"The study data not only showed complete and early resolution of COVID-19 related symptoms in the emricasan group compared to the placebo group, which continued to have symptoms, but also provided substantial insight into disease mechanism, which will be critical in developing therapeutic options for COVID-19. We are excited to work with Histogen to bring Amerimmune's expertise to the emricasan development program as a demonstration of how physician-owned diagnostic laboratories can be the genesis of breakthroughs in medicine and participate fully in the advancement of novel therapies," said Dr. Oral Alpan, M.D. Chief Executive Officer of Amerimmune LLC.

"These positive results further reinforce the extensive clinical safety database of emricasan and strongly suggest that emricasan can potentially be developed as a therapeutic treatment for mild to moderate COVID-19, as well as other viral inflammatory diseases," said Richard W. Pascoe, Histogen's President and Chief Executive Officer. "We look forward to working with our colleagues at Amerimmune as we chart a strategic course for emricasan and its clinical development options and partnering opportunities."