Rebiotix said today it is expanding the Phase 1 study of its investigative RBX7455 drug designed to prevent recurrent Clostridium difficile infections after initial success in its two introductory cohorts in the trial.
The Roseville, Minn.-based company’s RBX7455 is a lyophilized, non-frozen oral capsule formation of its Microbiota Resoration Therapy which it says is designed to “rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patients intestinal tract.”
“Expansion of the Phase 1 study is a key advancement in the development of RBX7455 as it provides an opportunity to explore the potential efficacy of reduced dosing regimens of our oral capsule product in the prevention of recurrent C. diff. infection. RBX7455 is a ground-breaking product in that its oral capsule design is the first in the microbiome industry not requiring storage in frozen conditions. As such, patients are able to administer RBX7455 at home as they would a typical oral capsule medication, which potentially makes RBX7455 ideally suited for diseases where chronic or repeat dosing is required,” CEO Lee Jones said in a press release.
In the investigator sponsored, prospective, proof of concept dosing Phase 1 study, Rebiotix enrolled 10 patients in 2 arms looking to explore the use of the drug to prevent recurrent C. diff. The company is now looking to expand into two additional arms with 10 patients per arm and reduced dosing regimens from the first 2 arms.
Rebiotix said it is hopeful to see data from the first two cohorts of the study released by mid-2018.
“We look forward to the continued progress of the RBX7455 Phase 1 study as well as our Phase 3 study of RBX2660, our lead microbiome drug candidate. Importantly, since both drugs were developed with our MRT platform, we can leverage knowledge from the extensive RBX2660 clinical program, as well as research into the drug’s rehabilitative impact on the gut microbiome, to inform and expedite the development of RBX7455,” Jones said in a prepared statement.
In September, Rebiotix reported raising $8.5 million in a $10 million offering, according to an SEC filing.