Once granted by the United States Patent and Trademark Office (USPTO), this patent will be valid until 2032.
RHB-104 is a proprietary, orally-administered antibiotic combination with potentially potent intracellular, antimycobacterial and anti-inflammatory properties. It has been patents in many countries, including the U.S., Australia, Canada, Japan and across Europe, with new patent claims presently being pursued.
The antibiotic therapy was tested in a Phase 2a, proof-of-concept clinical study (NCT01717664; CEASE MS) in combination with Rebif (interferon beta-1a) in 18 RRMS patients. The results were announced in December 2016, and safety data and clinical indications support further studies to investigate RHB-104’s potential in treating RRMS.
“Although designed as an exploratory proof-of-concept study in a very small patient population and not powered for efficacy, the study results demonstrate positive safety data and clinical signals, supporting additional studies to better investigate the therapeutic potential of RHB-104 in RRMS,” Ira Kalfus, MD, medical director of RedHill and the CEASE-MS study, said in a press release at that time.
RHB-104 is thought to have neuroprotective and anti-inflammatory properties, besides antibiotic activity. Its treatment approach was based on studies suggesting that infection caused by the intracellular bacteria Mycobacterium avium subspecies paratuberculosis (MAP) is linked to the development of MS, possibly through MAP-triggered abnormalities of the immune system.
“We are very pleased with the final results from the CEASE-MS Phase IIa proof-of-concept study with RHB-104 for relapsing-remitting multiple sclerosis (RRMS). The findings from the study, including safety, clinical and MRI, support the therapeutic potential of RHB-104 as an add-on therapy in RRMS. The final results from patients who completed the 48-week study period demonstrate marked improvement over historical self-control, suggesting the treatment effect of RHB-104 is maintained after discontinuing RHB-104,” Kalfus added.
RHB-104 is being tested in other diseases as well. It is currently in a Phase 3 study of Crohn’s disease (the MAP US study). It is also being developed as a potential treatment of nontuberculous mycobacteria (NTM) infections, and a Phase 3 study of RHB-104 in NTM infections is now at the planning stage.