Appili Therapeutics, a biopharma company focused on anti-infective drug development, announced that it has signed a collaboration, development and supply agreement with Dr Reddy’s Laboratories and Global Response Aid (GRA). This agreement follows on and is harmonised with the previously announced global licensing transaction (excluding Japan, Russia, and China) between DRL, GRA and FUJIFILM Toyama Chemical (FFTC), the originator of Avigan tablets. The agreements work together to coordinate and accelerate the worldwide development, commercialisation, and distribution of Avigan tablets (favipiravir) for the potential treatment and prevention of COVID-19.

In joining the global consortium to advance Avigan, Appili will assume key responsibilities for the design and implementation of the consortium’s global clinical programs and related work, including, but not limited to, the design and implementation of multiple pivotal Phase 3 trials to enable regulatory submission, review, and, if supported by data, approvals for the use of Avigan tablets in the treatment or prevention of COVID-19 in the US, Canada and internationally. The clinical development strategy will focus on evaluating Avigan tablets for early treatment and post-exposure prophylaxis in the community setting.

Dr Reddy’s and GRA will continue to be responsible for the research and development, manufacturing, commercialisation, and distribution of Avigan. FFTC is the innovator that originally developed Avigan for use in pandemic influenza and is supplying its knowledge base, including clinical data and intellectual property, in support of the consortium’s operations. In collaboration with its partners, Appili will design and oversee Phase 3 clinical trials to support regulatory submissions worldwide. Appili will be responsible for the US and Canadian clinical trials conducted on behalf of the consortium and will receive a profit share on all US and Canadian sales for a specified term. Appili is also eligible to receive royalties on sales in Europe and Latin America for a specified term.

“To address the ongoing threat of COVID-19 we must not only identify effective agents through rigorous clinical evaluation, we must also ensure they are widely available, which is a particular challenge in COVID-19, where billions of people from every corner of the globe are at risk from this threat,” said Dr Armand Balboni, Chief Executive Officer at Appili Therapeutics.

“This consortium is designed to do just that, with world-class expertise not only in drug development but also in manufacturing and commercialization to support access. We are thrilled to join this group of industry leaders in their global effort, contributing our drug development expertise and extensive experience with Avigan to accelerate its development on a globally coordinated basis. We look forward to the timely outcomes of our ongoing and soon-to-be initiated late-stage clinical trials to evaluate Avigan as the first orally available anti-viral treatment option for COVID-19,” he said.

Appili has previously announced a Phase 2 trial evaluating the use of favipiravir to control outbreaks of COVID-19 in long-term care facilities and a Phase 3 trial in the United States evaluating the use of Avigan for the early treatment of patients with mild-to-moderate COVID-19 symptoms. Working with the consortium, Appili expects to expand its favipiravir clinical programs internationally.