Sagent Begins NIAID-Sponsored Study Investigating Outpatient COVID-19 Treatments

Sagent Pharmaceuticals announced Camostat mesilate, is one of four therapies being added to the existing ACTIV-2 Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID), which was launched by the National Institutes of Health (NIH) and the AIDS Clinical Trials Group (ACTG) in May 2020.

ACTG was tasked with leading a Master Adaptive protocol under the Accelerating COVID-19 Therapeutic Interventions and Vaccine (ACTIV) partnership by Operation Warp Speed (OWS), the U.S. government's multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The ACTIV-2 trial will continue to evaluate monoclonal antibodies and other small molecules for outpatient COVID treatment. Camostat is the first orally administered agent to be included in the outpatient Adapt Out COVID trial.

ACTIV-2 is a public-private partnership to create a coordinated research strategy that prioritizes and speeds development of the most promising treatments. ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and also receives support from OWS.

"Studying COVID-19 related treatments and vaccines is the most important scientific research being conducted on the planet today, and we are proud to be contributing to the vital work of this NIAID study," said Dr. Peter Kaemmerer, Chief Executive Officer of Sagent. "Camostat is the only oral agent being tested in this study. With our inclusion in this trial, in addition to our ongoing Phase II study, we hope to show the efficacy of Camostat in the early treatment of outpatients with COVID."

Adapt Out COVID is a randomized, blinded, controlled adaptive platform trial that allows addition of promising investigational agents over the course of the study, in order to efficiently test a variety of new agents against placebo within the same trial infrastructure. In addition to studying the safety and efficacy of these investigational agents, the Adapt Out COVID trial also aims to determine whether they are able to decrease viral shedding, thereby potentially preventing transmission of SARS-CoV-2 (the virus that causes COVID-19). Participants will take the first oral dose of Camostat at the enrollment visit and subsequent doses at home.

In addition to the NIAID sponsored Adapt Out COVID trial, Sagent is currently conducting its CAMostat Efficacy vs. pLacebo for Outpatient Treatment of COVID-19 (CAMELOT) Trial. CAMELOT is a multicenter, randomized, double-blind, placebo-controlled Phase II trial evaluating the efficacy of Camostat to reduce the rate of hospitalization and viral shedding in ambulatory patients with COVID-19 with one or more risk factor for severe disease.

Previous in vitro studies demonstrated that Camostat inhibits transmembrane protease serine 2 (TMPRSS2) mediated activation of the SARS-CoV-2 spike (S) protein within the ACE2 receptor complex and thereby blocks entry into host cells and viral replication1. Camostat has been widely used in Japan for reflux esophagitis, dyspepsia, and chronic pancreatitis for more than 30 years, but to date there has been no published randomized control trials in humans for COVID-19 treatment. There are no concerning safety trends from post-marketing surveillance in patients who have used the drug for months to years.