BRIEF—US government sees potential in RedHill's opaganib for acute radiation syndrome

28 February 2023

The Radiation and Nuclear Countermeasures Program (RNCP) of the National Institute of Allergy and Infectious Diseases, part of the USA’s National Institutes of Health, has selected RedHill Biopharma’s opaganib for the nuclear medical countermeasures product development pipeline.

The small molecule pill is seen as a potential treatment for acute radiation syndrome (ARS) and its use in this setting will now be tested in studies designed in collaboration with RedHill.

Dror Ben-Asher, the company’s chief executive, said: “The selection of opaganib by the RNCP for studies in its product development pipeline for ARS provides an important validation of opaganib’s potential for that indication. The RNCP collaboration is expected to significantly accelerate and enhance the opaganib development program, allowing access to key research models and the resources required to undertake such testing.

“This exciting development follows last week’s news regarding the applicability of the Animal Rule development pathway to opaganib for ARS, emanating from our recent Food and Drug Administration (FDA) Type-B meeting.

“RedHill is looking forward to working with both the RNCP and FDA on the development and approval of opaganib as a potential radiation medical countermeasure. In addition, we are continuing our collaboration discussions with other US government agencies and other governments regarding opaganib for ARS, COVID-19 and other indications.”

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