Appili Therapeutics begins Phase 3 clinical trial for Avigan in fight against Covid-19

Appili Therapeutics, a Canadian infectious disease biopharmaceutical company, has announced a major milestone in its fight against Covid-19: the commencement of the Phase 3 clinical trial for Avigan tablets (favipiravir). This pivotal trial, designed to assess the potential of Avigan as an oral treatment for Covid-19, marks a significant step in the ongoing battle to curb the pandemic. With dosing already underway for the first participant, Appili Therapeutics, in partnership with PRA Health Sciences, is now set to test the efficacy of Avigan across 47 outpatient sites.

Key Focus of the Phase 3 Trial

The Phase 3 PRESECO clinical trial is a randomized, double-blind, placebo-controlled study aimed at evaluating Avigan’s ability to alleviate symptoms and prevent disease progression in Covid-19 patients. Approximately 826 participants will be enrolled in the trial, which will primarily target individuals with mild-to-moderate symptoms who have tested positive for the virus. The goal is to intervene early, reducing the need for hospitalization and minimizing severe complications associated with Covid-19.

This clinical trial is particularly significant as it is the second Covid-19-related study sponsored by Appili Therapeutics to begin dosing this quarter, underscoring the company’s commitment to addressing the urgent unmet needs of patients in the early stages of infection. The company expects to disclose preliminary data from the study in the first half of 2021, marking a key moment for both the company and the global fight against Covid-19.

The Promise of Avigan in the Covid-19 Pandemic

Avigan, originally developed by FUJIFILM Toyama Chemical for the treatment of influenza, has already been approved as a countermeasure for pandemic influenza in Japan. In addition, favipiravir-based antiviral drugs, including Avigan, have received emergency use authorization for Covid-19 treatment in countries such as Russia and India. These approvals have paved the way for broader trials, with Appili Therapeutics spearheading efforts to assess the drug’s potential for Covid-19 treatment in North America.

The PRESECO trial is not only a test of Avigan’s efficacy but also a demonstration of Appili Therapeutics’ strategy to ensure the early availability of antiviral therapy to high-risk individuals. Appili’s clinical approach, which includes a multi-pronged trial design, targets individuals who are either diagnosed with Covid-19 or have been recently exposed to the virus. This includes those over the age of 50, individuals with significant co-morbidities, and frontline workers who face increased risk of severe infection.

Dr. Yoav Golan, Chief Medical Officer of Appili Therapeutics, stated that early intervention is crucial in preventing severe Covid-19 complications, a need that remains unmet in current treatment options. According to Dr. Golan, oral antivirals like Avigan may become essential tools in managing Covid-19, particularly as vaccines are rolled out globally. He emphasized that Avigan’s pill format and stability make it a viable option for treatment in a pandemic setting.

Appili Therapeutics’ Role in Global Covid-19 Treatment

Appili Therapeutics has played a key role in the development and distribution of Avigan through its collaboration with international partners. In October 2020, the company joined a consortium with FUJIFILM Toyama Chemical, Dr. Reddy’s Laboratories, and Global Response Aid. This consortium is focused on the global development and distribution of Avigan tablets for Covid-19 treatment and prevention, excluding certain countries such as Japan, China, and Russia. Appili Therapeutics has taken on the responsibility of designing and executing the clinical programs within this partnership.

Dr. Armand Balboni, CEO of Appili Therapeutics, shared that the company is fully committed to gathering robust clinical data that will demonstrate Avigan’s potential in addressing the global pandemic. Balboni emphasized that providing early antiviral access is a cornerstone of Appili’s strategy, with a focus on vulnerable populations who are at risk of advancing to more severe stages of Covid-19.

The Future of Covid-19 Treatment and Prevention

As the global medical community continues to tackle the Covid-19 crisis, antiviral drugs like Avigan may offer a crucial solution to preventing severe disease progression. With its oral form and proven shelf-life stability, Avigan represents a promising treatment option, especially for those who are diagnosed early in the course of infection. If the PRESECO trial results support its efficacy, Avigan could become an essential tool in preventing Covid-19 hospitalizations and reducing overall disease burden worldwide.

Appili Therapeutics’ continued progress in the Phase 3 PRESECO trial will be critical in determining whether Avigan can fulfill its potential as a cornerstone of Covid-19 treatment in the outpatient setting. The company is poised to reveal early data that could transform the landscape of Covid-19 therapeutics, potentially offering a vital treatment option for millions.