RDHL News & Events

RedHill Biopharma is actively discussing potential collaborations for advancement of its investigational oral drug, opaganib, to combat Ebola virus disease or EVD, which can be fatal in approximately half of all cases, including the WHO's SOLIDARITY CORE clinical trial platform and pharma collaborations. Opaganib is an orally administered, host-directed, small molecule SPHK2 inhibitor with demonstrated antiviral properties in advanced clinical stage. Peer-reviewed published data shows opaganib's host-direction action stems from its ability to inhibit replication of viruses like SARS-CoV-2 and Ebola. In EVD specifically, opaganib offers a potential dual mechanism of action; blocking the PI3K/Akt pathway critical for filovirus entry and suppressing NLRP3 inflammasome and reducing IL-6/TNFalpha and S1P-mediated vascular permeability. The company has provided information to relevant government, industry and other organizations, regarding supply readiness and all available clinical and preclinical safety and efficacy data to aid rapid clinical and regulatory discussions. Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications. Opaganib is an investigational new drug. It has not been approved by any regulatory authority and is not available for commercial distribution. Inclusion in the WHO CORE platform cannot be guaranteed.

RedHill Biopharma announced new in vitro testing results demonstrating RHB-204's comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis, or MAP, killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill's RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs MAP-targeted therapeutic approach to the treatment of Crohn's disease, or CD. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects. A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population. RedHill is actively pursuing partnerships and collaborations for this program, in addition to non-dilutive external funding sources. The development of RHB-204 is supported by published clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints. The Phase 3 study also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy.