IND submitted for opaganib, potential COVID-19 treatment
Posted: 20 April 2020 | Victoria Rees (European Pharmaceutical Review) | 2 comments
RedHill Biopharma has submitted its Investigational New Drug application for its drug opaganib, for the treatment of COVID-19, to the FDA.
RedHill Biopharma has announced it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to study its investigational drug, opaganib (Yeliva®, ABC294640), for the treatment of SARS-CoV-2, the virus causing the COVID-19 pandemic. The IND submission follows preliminary discussions with the FDA on the study design.
The proposed randomised, double-blind, placebo-controlled Phase IIa study is intended to evaluate the safety and efficacy of opaganib in up to 60 adult patients hospitalised with positive SARS-CoV-2 and pneumonia in the US.
Opaganib is a new chemical entity and is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-viral and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, the drug blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signalling molecule that promotes cancer growth and pathological inflammation.
Several pre-clinical studies support the potential role of SK2 in the replication-transcription complex of positive-strand single-stranded RNA viruses, similar to coronavirus. By inhibiting SK2, the drug potentially blocks viral replication and pathological inflammation.
“We are moving quickly to advance the clinical development of opaganib for COVID-19 and in parallel to expand access to opaganib for patients under compassionate use to help address the global pandemic caused by SARS-CoV-2,” said Dr Mark Levitt, Medical Director at RedHill. “We are encouraged by the preliminary findings from the first patients treated with opaganib under compassionate use indicating objective clinical improvement and look forward to collaborating closely with FDA to validate the effectiveness of opaganib in treating COVID-19 in a controlled clinical setting.”
According to the company, a compassionate use programme with opaganib is ongoing in Israel, with five patients treated to date in a leading hospital. Preliminary findings from all five patients have shown an improved C-Reactive Protein (CRP), an inflammatory biomarker, with four of the five patients also demonstrating measurable clinical improvement, including reduced supplemental oxygenation and higher lymphocyte counts within days following treatment initiation with the drug.
In order to facilitate access to opaganib, various programmes are currently under discussion in other countries, says the company. In line with the current global shift from compassionate use programmes with COVID-19 therapeutic candidates to more rigorously-controlled studies, the compassionate use programme in Italy is planned to be converted to a clinical study in order to generate more robust clinical data in a controlled setting for regulatory purposes.
A total of 131 subjects have been dosed with opaganib to date in ongoing and completed Phase I and Phase II clinical studies in oncology indications in the US.
Related topics
Clinical Development, Clinical Trials, Drug Development, Research & Development (R&D), Therapeutics, Viruses
I also want to know why more news channels and more people are not talking about this; it seems to me that the CDC under Dr. Fauci may be trying to keep the lid on good therapies which might present a miracle cure for this awful disease,—opaganib has anti-cancer, anti-inflammatory and anti-viral properties which make it well-tolerated, and able to avert the “cytokine storm” of an overreaction in the immune system, if we are fortunate, and also prevent viral replication! Is that Foundation on the Board of which he sits looking to patent another vaccine, months and maybe a year or more down the road while people die? The vaccines from the Gates Foundation were a failure in India, and anyway, corona viruses mutate quickly, and in fact Chinese studies indicate this one has already done so into 30 strains, some much more virulent than the others, which makes the development of any vaccine, especially one with recombinant features of several viruses, difficult. Opaganib appears to be one of the more promising drug therapies for Covid-19!
why is this not front page news, talked about on all new channels, all around the world?