Inovio Gets Authorization For Phase 3 Trial Of INO-4800 COVID -19 Vaccine Candidate In India

(RTTNews) - Inovio Pharmaceuticals, Inc. (INO) Wednesday said it has received authorization from India's Central Drugs Standard Control Organization to proceed with the Phase 3 segment of the global Phase 2/3 trial, INNOVATE, in India for INO-4800. The trial will evaluate the efficacy of INO-4800 in a two-dose regimen of 2.0 mg per dose.

Earlier, the company has received regulatory authorization in Brazil, the Philippines, Mexico, and Colombia.

The study in India plans to one month apart administration, in 2-to-1 randomization in men and non-pregnant women 18 years of age and older. The primary endpoint of this case-driven Phase 3 trial is virologically confirmed symptomatic COVID-19.

The biotechnology company that designs DNA medicines said it will be partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. or Advaccine to conduct the INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa.