Non-Frozen Oral Capsules Could be Next Step in C. difficile Treatment

In the first case of its kind, researchers used lyophilized non-frozen oral capsule RBX7455 (Rebiotix) to treat a patient with recurrent Clostridium difficile (C. difficile) infection.

RBX7455 is a part of Rebiotix’s Microbiota Restoration Therapy (MRT) program, a standardized and stabilized drug technology designed to rehabilitate the gut — the enterprise aims to “harness the power of the human microbiome to treat challenging diseases”. This method delivers varied, live microbes into a patient’s intestinal tract through a ready-to-use and easy-to-administer format.

“RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home,” study leader Dr. Sahil Khanna Assistant Professor of Medicine, Department of Gastroenterology and Hepatology at the Mayo Clinic said in a press release. Dr. Khanna also stressed that new therapies for recurrent C. difficile infection are urgently needed, as it is a debilitating, costly and potentially even a life threatening condition. Recurrent cases of C. difficile can be especially challenging to treat, because the standard of care can sometimes lead to recurrence, the statement explained.

The Mayo Clinic treated the first patient this way as part of a larger prospective, single center, two-arm, proof of concept study that is expected to enroll 20 patients. This is the first clinical study of an oral microbiota therapy where the patients would be able to self-administer their medications at home, the press release continued.

“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota based drug development,” Lee Jones, president and CEO of Rebiotix, added in the statement.

According to Jones, RBX7455 holds promise as a groundbreaking product for the company and for the microbiome industry as a whole, because these lyophilized oral capsules don’t need to be refrigerated or frozen. This lack of special handling allows the capsules to be easily stocked in a pharmacy and makes it moreavailable for treatments in numerous cases where chronic or repeat dosing is required.

Another product from Rebiotix, RBX2660, recently completed a Phase IIb trial to examine its safety and efficacy. The product is another in Rebiotix’s arsenal designed to restore microbiota as a prevention method for C. difficile infection for use failed use of antibiotics. The US Food and Drug Administration (FDA) has already granted Orphan Drug Status, Fast Track status and Breakthrough Therapy Designation for RBX2660.

The statement, titled in full “Rebiotix Treats First Patient in Phase 1 Study of RBX7455, an Orally Delivered Broad-Spectrum Non-Frozen Microbiota Capsule for Recurrent Clostridium difficile Infection,” was released by the company.

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