- RHB-107 included in the U.S. Department of Defense-supported ACESO PROTECT multinational platform trial for early COVID-19 outpatient treatment. The 300-patient Phase 2 study received FDA clearance and is estimated to be completed by the end of 2024.
- Opaganib awarded a further $1.7 million in U.S. government medical countermeasure (MCM) development funding – additional to the multimillion dollar-valued NIH Radiation and Nuclear Countermeasures Program (RNCP) product development contract for gastrointestinal acute radiation syndrome (GI-ARS).
RedHill Biopharma Ltd., a specialty biopharmaceutical company, today provided first half, 2023, financial results and operational highlights.
Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “RedHill has delivered significant achievements in the first half of 2023. We are now debt-free with a significantly reduced cost-base. Our two lead R&D candidates, RHB-107 and opaganib, are progressing their development in outpatient COVID-19 and Acute Radiation Syndrome, respectively, both supported extensively by U.S. government funding. Additionally, we are in active discussions with multiple parties regarding potential divestment of certain RedHill assets, in order to further strengthen our balance sheet and enhance our focus.”
R&D Highlights
Opaganib (ABC294640) – A novel broad-acting, host-directed oral small molecule capsule targeting radioprotection, COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications.
Nuclear Medical Countermeasures (Acute Radiation Syndrome):
- On July 21, 2023, the Company announced that opaganib had been awarded a further $1.7 million in U.S. government funding, via a SBIR grant to the Company’s development partner, Apogee. This SBIR grant will support research to further the development of opaganib as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). This grant is in addition and complementary to the multimillion dollar-valued RNCP product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development, announced on February 28, 2023.
- On February 28, 2023, the Company announced that the RNCP, of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has selected opaganib for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). As part of this collaboration, contractors directed and supported by the RNCP will undertake studies, designed in collaboration with RedHill, to test opaganib in established ARS models. This announcement followed the February 15, 2023, announcement that the FDA provided guidance on the use of the Animal Rule for opaganib’s developmental pathway for Acute Radiation Syndrome (ARS), utilizing pivotal animal model efficacy studies instead of human clinical trials. Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher. These announcements followed publication of data from eight U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with:
– Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
– Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival. - Additional collaboration discussions with the U.S. and other governments are ongoing.
Pandemic preparedness and oncology:
- Preclinical development of opaganib, in collaboration with the U.S. Army and NIAID, for various antiviral indications is ongoing.
- On May 1, 2023, the Company announced that the U.S. Patent and Trademark Office (USPTO) had granted a new patent for opaganib in respect to combination compositions for treatment of cancer, extending protection to October 2036.
RHB-107 (upamostat) – A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications.
Outpatient treatment of COVID-19:
- On July 31, 2023, the Company announced that RHB-107 (upamostat) had been accepted for inclusion in the U.S. Department of Defense-supported Austere environments Consortium for Enhanced Sepsis Outcomes’ (ACESO) PROTECT multinational platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand, Ivory Coast and South Africa. The 300-patient Phase 2 study has received FDA clearance to start and is estimated to be completed by the end of 2024.
- On January 3, 2023, the Company announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International Journal of Infectious Diseases11. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.
- Discussions are ongoing for external non-dilutive funding for additional late-stage COVID-19 clinical development.
Pandemic preparedness / additional viral indications:
- RHB-107 is also the subject of several cooperative research projects with government and non-government bodies, evaluating RHB-107 against multiple viral targets, including influenza and Ebola (amongst others).
View the full readout: RedHill Biopharma Provides H1/23 Financial Results and Operational Highlights