Healthcare solutions provider Global Response Aid (GRA) announced that a Phase 3 US-Canada clinical trial of anti-viral Avigan (Reeqonus) will continue amid signs the drug could be effective in the treatment of patients with mild to moderate cases of COVID-19.
An independent Data and Safety Monitoring Board (DSMB) recognized by the US Food and Drug Administration has recommended continuation without modification of an ongoing Phase 3 PRESECO (PREventing SEvere COvid-19) trial that is evaluating Avigan as a potential outpatient oral therapy for patients with mild-to-moderate COVID-19.
Interim results indicate that Avigan, the brand name for generic Favipiravir, could shorten recovery times and prevent progression in COVID-19 patients in the early stage of infection. The conclusion of the midterm analysis is that, if current trends continue, the required statistically measured threshold for efficacy can be met at the completion of the study. GRA and study co-sponsors Appili Therapeutics will continue the current PRESECO trial, which is expected to enroll its last patient on June 30.
The US-Canada PRESECO trial is investigating whether Avigan can safely and effectively shorten recovery times in early-onset COVID-19 cases and shorten the duration of patient viral loads, lowering the propensity of the virus to spread.
Together with Indian life sciences leader Dr Reddy’s, Dubai-based GRA owns the rights to manufacture, market and distribute Avigan outside of Japan, China and Russia. GRA sponsored the trial in collaboration with Appili Therapeutics, a Canadian biopharmaceutical company specializing in development of drugs for infectious diseases.
Dr Richard Kaszynski, one of the leading experts on Favipiravir, said, “The efficacy signals and safety profile observed thus far appear encouraging. The implications of this study are global and it would be prudent to steadfastly maintain the current momentum through full enrollment in order to rapidly reach statistically significant endpoints. The establishment of an early outpatient treatment that could concomitantly serve as a novel strategy to prevent onward viral transmission is an exciting and noteworthy endeavor.”
Mitch Wilson, CEO of GRA, said, “We are confident we are on track for delivering a home treatment for COVID-19 by summer this year, subject to regulatory approvals. The global rollout of COVID-19 vaccines, while welcome, won’t eliminate the need for effective treatment of infected patients. We know that we will need more in our COVID-fighting arsenal. We know we will need the ability to treat people who get the virus because they haven’t been vaccinated or who become infected despite having received vaccines. Avigan could be a powerful tool because it is a relatively inexpensive, oral medication that comes in tablet form and can be prescribed early to prevent hospitalization.”
Favipiravir was developed by FujiFilm Toyama Chemical as an anti-viral for novel or re-emerging influenzas. In 2020, GRA and Dr Reddy’s signed an agreement with FujiFilm Toyama Chemical for global commercialization of the drug outside Japan, China and Russia.
In its branded and generic forms, it has been used to treat more than 400,000 patients. The drug is available in tablet form for outpatient and inpatient use, and is stable and easy to transport without need for refrigeration. It has a shelf life of ten years.