RBX2660: Ph IIb data

Data from the blinded portion of the North American Phase IIb PUNCH CD2 trial in 127 patients with recurrent CDI showed that 1 or 2 enema administrations of RBX2660 led to treatment success in 63.9% of patients vs. 45.5% of patients treated with 2 doses of placebo (p=0.046). A single dose of RBX2660 (n=42) led to treatment success in 66.7% of patients, and 2 doses of RBX2660 (n=41) led to treatment success in 61% of patients.

Treatment success was defined as the absence of CDI-associated diarrhea without the need for retreatment with a CDI anti-infective therapy or fecal transplant through 8 weeks post-treatment. In the study’s blinded portion, patients were randomized to receive 2 doses of placebo, 2 doses of RBX2660, or 1 dose of RBX2660 followed by 1 dose of placebo with each dose separated by 7 days. Treatment failures could enter the trial’s open-label portion to receive either up to 2 doses of RBX2660, or another CDI anti-infective. No patients elected to receive another CDI anti-infective, according to the company...