Cedars-Sinai Medical Center began enrolling the first of a targeted 150 patients suffering from IBS with constipation (IBS-C) in the Phase II clinical trial around the turn of the year. The trial is assessing the safety and efficacy of SYN-010, a modified release, oral formulation of the blood cholesterol drug lovastatin.
In August, Synthetic Biologics revealed Cedars-Sinai had contacted almost 600 IBS-C patients and prescreened almost 350 potential participants.
However, while Cedars-Sinai prescreened more than enough patients to fully enroll the study, the use of laxatives among potential participants meant many people were unable to join the trial. The barrier to enrollment forced Synthetic Biologics to delay data from the study from the fourth quarter of 2019 to first half of 2020.
Talking to investors on a recent quarterly results conference call, Vince Wacher, head of product and corporate development at Synthetic Biologics, sketched out the actions the study team is taking to ensure it hits the revised target.
Wacher said, “We have initiated a program now through another vendor that could triple that outreach and expand the area of the outreach so that we can get more patients in from more distant sites and reimburse them for travel. By doing that, we hope to rapidly accelerate the enrollment but also diversify the population beyond just the area around Greater Los Angeles.”
Synthetic Biologics has enlisted the service provider to support the expanded enrollment initiative underway at Cedars-Sinai, which has now contacted almost 1,000 potential participants in the trial.
The need to expand the outreach activities reflects the problems encountered by the researchers. Specifically, the screen failure rate has been higher than expected, in part because ongoing laxative use by potential participants is distorting IBS-C symptoms and other baseline measures.
Potential participants are told to stop taking laxatives. However, the length of the screening period — two weeks — and concerns among potential participants about foregoing their current treatments means that some continue to take medications.
Cedars-Sinai stepped up its education and interactions with patients about the topic earlier in the year, leading Synthetic Biologics to express the hope that the screen failure rate will fall over time. However, Synthetic Biologics has nonetheless decided it also needs to increase the number of people screened by the trial, leading it to enlist the support of the vendor.