Regulatory support from the German Paul Ehrlich Institute and the USA NIH-ACTIV
Paul Ehrlich Institute
The PEI evaluated our IBDV program for the second time in 2020 and agreed that the data presented is adequate to support an oral delivery Phase I COVID-19 clinical trial. An excerpt from the advisory meeting with the experts of Paul Ehrlich Institute is copied below (the full briefing document and the minutes of the meeting are available upon request).
Text Box: Question 4:
Does PEI agree that the GLP non-clinical toxicology studies conducted to date and reviewed in the briefing document are adequate to support the proposed Phase I trial of R903/78 for COVID-19?
PEI Response:
PEI agreed that the data presented is adequate to support a delivery Phase I clinical trial.
USA NIH-ACTIV
The ACTIV Agent Prioritization Team has thoroughly reviewed and evaluated Birnavirus/IBDV strain R903/78 against a set of pre-defined criteria, including rationale of use for treating COVID-19 or its resulting symptoms, mechanism of action, safety, and relevant preclinical and clinical data. Upon careful deliberation, the team felt that Birnavirus/IBDV strain R903/78 shows merit as a potential treatment for COVID-19. Quoted from the email of Joseph P. Menetski, PhD Associate Vice President Research Partnerships Foundation for the National Institutes of Health, Inc. Bethesda, MD 20852.
