RedHill Awaits US Patent for Antibiotic Combo, RHB-104, as Potential RRMS Therapy

RedHill Awaits US Patent for Antibiotic Combo, RHB-104, as Potential RRMS Therapy

RedHill Biopharma has received a Notice of Allowance for a new patent on RHB-104 its potential therapy for patients with relapsing-remitting multiple sclerosis (RRMS).

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.

One comment

  1. Lisa Hopps says:

    I was told by several doctors that my ongoing cases of undiagnosed Lyme disease in the summer of 1983 were the triggers for my ms which was diagnosed in November of that year. I was finally diagnosed with late stage Lyme disease five years later in 1988! It was my former boss ( entomologist) who contacted me in 1988 and told me I should check into Lyme disease as we had done mosquito research the summer of 1983 at Ft. Eustis Va. I was covered with ticks the whole summer but continued to work even though I was quite sick and covered with many ECM (Lyme ) rashes. By the time I was treated for Lyme it was too late and the neurological damage was done. Today I accept that I have ms and Lyme. I have been taking Betaseron and Extavia since 1993. It seems to keep me the same– numb legs and arms, no balance,extreme fatigue, bladder and bowel problems, walking with crutches, cognitive problems……! I would love to take a pill after all these years of shots. I wonder if this new combination pill would help someone like me???

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