Mateon Pharma submits IND to the FDA to approve new phase II study of OT 101 for the treatment of COVID-19 pandemic.

Mateon Therapeutics Inc.announced it has submitted an Investigational New Drug (IND) application to the FDA)to study its investigational drug, OT-101, for the treatment of COVID-19 pandemic.The proposed randomized, double-blind, placebo-controlled Phase II study is intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with COVID-19 and pneumonia in the US.

OT-101 is a potent inhibitor of SAR-CoV2 replication with efficacy and safety index on par or superior to Remdesivir- a Gilead’s drug. Unlike Remdesivir- OT-101 targets not only the virus replication but also the often lethal clinical sequelae of COVID-19, including pneumonia and fibrosis. OT-101 is a proprietary, first-in-class, TGF-beta antisense with broad efficacy against solid tumors including pancreatic cancer, glioblastoma, and melanoma across multiple phase II oncology trials.

“We are advancing quickly the clinical development of OT-101 as multimodal drug against COVID-19. It is imperative to look at a basket of drug candidates to insure finding the cure for COVID-19. Additionally, an effective treatment for COVID-19 is more likely a cocktail of drugs,” said Dr Vuong Trieu, CEO of Mateon Therapeutics. “We look forward to collaborating closely with leading clinical investigators and the FDA to validate the effectiveness of OT-101 in treating COVID-19 in a controlled clinical setting.”