Oncotelic Therapeutics has reported that its lead drug candidate, OT-101, met the safety and efficacy goals of Phase II C001 clinical trial in individuals with severe Covid-19 who are admitted to the hospital.
An anti-TGF-β ribonucleic acid therapy, OT-101 demonstrated single-agent activity in individuals with relapsed/refractory cancer in various trials.
As part of the immune evasion mechanisms, tumour cells and the SARS-CoV-2 virus produce TGF- β.
As a result, suppressing TGF- β using OT-101 could have an effect on both cancer and Covid-19.
As compared to standard antiviral therapies and vaccines, OT-101 potentially works against several respiratory viruses by acting on the host protein.
The randomised, placebo-controlled, double-blind, multicentre trial evaluated OT-101 in combination with the standard of care (SOC) as against placebo plus SOC in a total of 32 subjects.
SOC comprises dexamethasone, a drug claimed to boost outcomes in individuals with severe Covid-19.
Findings showed that OT-101 met the safety goals of the trial, indicating that the TGF-β inhibitor therapy was safe to use in people with Covid-19, including those with severe/critical disease.
Furthermore, the mortality was 4.5% in the subjects treated with OT-101 compared to 20% in the placebo arm on day seven, meeting the efficacy signals.
On day seven, 89% of the subjects who received OT-101 had more than 96% reduction in viral load as against 67% in the placebo group.
Overall survival rose by three times for critical patients treated with OT-101, reported at 14 days for OT-101 versus four for those who received placebo.
Oncotelic CEO and chairman Dr Vuong Trieu said: “It is gratifying that the TGF-β concept that we put forward has now been validated.
“The data form the basis for further development of OT-101 as a viable treatment for severe respiratory viral infections, including flu and Covid-19.”
In August 2019, Mateon, which formed due to a reverse merger with Oncotelic, took over the computer and artificial intelligence company PointR Data.