Experimental MS Oral Antibiotic Combination Therapy Showing Promise in Phase 2a Study, RedHill Biopharma Reports

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RedHill Biopharma, Ltd. recently announced promising interim results from its ongoing CEASE-MS Phase 2a clinical trial evaluating the safety and efficacy of a fixed dose of RHB-104 as an add-on therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS).

RHB-104 consists of an oral capsule formulation of an antibiotic combination therapy — 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine — with strong intracellular, anti-mycobacterial, and anti-inflammatory properties. Originally developed for the treatment of Crohn’s disease, this drug is now being pursued as a complementary therapy for RRMS due to its potential anti-inflammatory and neuroprotective activity.

The CEASE-MS study, “Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis,” is a proof-of-concept clinical trial also exploring the efficacy of RHB-104 as an adjuvant therapy to interferon beta-1a in 18 patients with RRMS. The recently announced results refer to safety and clinical evidence after 24 weeks of treatment.

Annualized relapse rate (ARR) at 24 weeks was 0.288 in the modified intent-to-treat (mITT) population (all study participants), and 0.0 in the per-protocol (PP) population (the cohort analyzed). These results compare favorably with previously reported data of interferon beta-1a therapies Avonex and Rebif, RedHill announced in a company press release.

Also at 24 weeks, 88 percent of the mITT patient population and 100 percent of the PP group were relapse free, compared with Rebif (75%) and with Avonex (63%) as standalone therapies. Moreover, no patients in the CEASE-MS study relapsed after week eight of treatment, and no increase in total Expanded Disability Status Scale (EDSS), a measure of disability in MS, was observed in any patient during the treatment period.

Results also indicated a reduction in MRI T2 lesion volume, a definition of burden of disease and indicator of response and progression in RRMS, at 24 weeks of treatment with RHB-104 as compared to baseline. Such results again compared favorably to previous data for Avonex and Rebif treatment. Importantly, RHB-104 was found to be safe and well-tolerated, and no drug-related serious side-effects were observed.

“We are very pleased with the interim results from the ongoing CEASE-MS Phase IIa proof-of-concept study with RHB-104 for relapsing-remitting multiple sclerosis (RRMS). The initial findings from the study, including safety, clinical and MRI, support the therapeutic potential of RHB-104 as add-on therapy in RRMS,” said Dr. Ira Kalfus, MD, medical director of RedHill and for the CEASE-MS study. “Although designed as an exploratory proof-of-concept study in a very small patient population and not powered for efficacy, the study interim results demonstrate positive safety data and clinical signals, supporting additional studies to better investigate the therapeutic potential of RHB-104 in RRMS.”

Dr. Radi Shahien, MD, principal investigator of the CEASE-MS study, added: “RRMS is a devastating disease with no known cure, limited treatment options and unknown cause, hence the importance of the development of RHB-104, an intracellularly acting, anti-mycobacterial, anti-inflammatory and orally administered drug candidate. CEASE-MS is … intended to investigate the groundbreaking hypothesis that a bacterial induced dysregulated immune system plays a critical role in the pathogenesis of MS. RedHill’s CEASE-MS study with RHB-104 is the first clinical study to evaluate the therapeutic potential of a triple antibiotic combination therapy, and specifically these intracellularly acting antibiotics, as add-on therapy in RRMS. The initial analysis of the study’s interim results provides encouraging clinical signals as well as important and reassuring safety data. In particular, the reduction of total T2 lesion burden over baseline, a key MS disease burden measurement, as well as relapse-free and stable EDSS data, are positive and meaningful signals, particularly given the small patient population in the study and the early time point of the data generated to date. I find the interim results very promising and am encouraged by the potential efficacy of RHB-104 in treating MS. I look forward to the completion of the study, further analyses and presentation of the final data at the appropriate international medical and academic forums.”

RedHill Biopharma, Ltd. is an Israeli company focused on the development and commercialization of oral-administered small-molecule medicines for inflammatory and gastrointestinal diseases.

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Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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  1. Michael howells says:

    Please help me i am loosing mobility on my right hand side of my body and its moving over to my left shoulder i have a full lesion on my left brain and another one on the front right hand side.

    • john Smith says:

      Stewed blueberries without water added seem to help me kill poisons in the body. High Alkaline low acidity diet, wet cell battery from iodinesource.com owned by phil thomas and based on the edgar cayce readings. Salad for lunch of just green vegetables without dressing sprinkled with gelatin.

  2. This is very gratifying affirmation of the triple antibiotic treatment that I’ve been on for two years. I am following the Combined Antibiotic Protocol as laid out by Dr David Wheldon in his treatment for MS. I have never taken any other MS drugs and my condition is 95% resolved. I probably have another 2 years on the antibiotics to make sure the cryptic phase are totally exterminated. The initial research was done by Dr Chuck Stratton at Vanderbilt.

  3. Shasha says:

    If antibiotics help the MS person may also have Lyme. Antibiotics hurt my gut lining/hurt my mitochondria and lowered my immune system. Mitochondria are the engines of the cell…burn food/oxygen and make ATP energy. Hurting them may make MS worse. Herbals are safer to kill Lyme.

    • tyler says:

      Autoimmune system is regulated by interleukin cytokines. There is heavy correlation between interleukin-17, Mycobacterium Avium complex bacteria, and autoimmune diseases of all type. Doesn’t mean it will eventually pan out but that’s the theory. Inflammation from this bacterial infection causes a flood of the cytokines which control the targeting of the immune system… And from there s#it happens.

      • Shasha says:

        Hi, Yes…I agree. I currently have Lyme, but MS started 30 years ago when I had two babies in a row that drained vitamins/good oils out of me and I didn’t know I was Celiac which also lowers nutrients absorbed. Gluten made antibodies to my thyroid and then my MS started due to low oxygen in my brain. Trying to kill Lyme/coinfections is hard since it mitochondria may get hurt. They said mitochondria maybe ancient bacteria that are helping the cells. Any swelling/inflammation in the brain cuts off oxygen. Fixing the Celiac helps the immune system work right. LDN helps block hidden gluten. To me killing Lyme and keeping the good bacteria in the body going strong is hard. Herbals help, but a person needs to rebuild the cells more than hurt the cells with medicine.

  4. I am the wife of the Dr David Wheldon mentioned above by Irene MacDonald. I started his treatment for my secondary progressive MS in 2003 and I took it all in all for four years. It is now 2016 and I have not had a single MS episode in all this time. I do still have a few MS relics: for instance though I can walk unaided, I can’t run. The best thing for me though, is that I have totally recovered the use of my right arm, which had become virtually paralysed, so I am now able to work again as a fine-artist.

    I did not have Lyme disease but I tested positive for chlamydia pneumonia.

    I think Redhill should be applauded for this work because if their combination off abx works as well for the people in the trial as my very similar combination did for me, MS might soon loose its label of being a disease for which there is no known cure.

  5. beniaiche ammar says:

    i have a serieus form of ms for that i have takene a combinaition of antibiotics still i feel better , welhdon s protocl

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