Cellceutix recently began screening participants and administering therapy for its Phase 2 trial assessing the drug candidate Brilacidin for the treatment of ulcerative proctitis, a mild form of ulcerative colitis.
The causes for the development of ulcerative proctitis and ulcerative proctosigmoiditis are not yet known, but the conditions are often initially treated with oral or rectal 5-aminosalicyclic acid or corticosteroids. However, using rectal corticosteroids for a long period of time is not recommended, since it is known to provoke potentially serious side effects.
Therefore, Cellceutix aims to provide a non-corticosteroid therapeutic option that offers not only anti-inflammatory effects, but also other benefits for the patients.
Brilacidin is the first of a completely new class of antibiotics called defensin-mimetics, a non-corticosteroid alternative to traditional treatments. The defensin-mimetic antibiotics are modeled after host defense proteins, which are considered the front-line of defense in the human immune system.
Brilacidin kills bacteria the same way as the human immune system, and so can can significantly reduce the risk of bacterial resistance.
The Phase 2 clinical trial, designed to primarily assess the remission of the condition (its primary endpoint), is expected to enroll 18 adult patients with ulcerative proctitis. Patients will be given Brilacidin through retention enema at three different concentrations once daily at bedtime for six weeks.
At the beginning and end of treatment, all patients will be submitted to an endoscopic assessment of the rectum and mucosa, up to 40 cm from the anal verge.
All endoscopic evaluations will be photographed and videotaped for eventual adjudication by an independent gastroenterologist.
The potential success of this Proof of Concept ulcerative proctitis trial would advance Brilacidin’s franchise into other inflammatory bowel diseases (IBD). Brilacidin will be administered with water in an enema, but a foam formulation of the drug to be used in additional studies is under development.
Cellceutix is enthusiastic about the beginning of this study, according to a press release.
“We are hopeful that Brilacidin can prove itself to be a new treatment for patients with ulcerative proctitis and look forward to Brilacidin possibly emerging as a novel therapy for the millions of patients suffering from this and other difficult-to-treat inflammation-based gastrointestinal conditions,” the release says. “Should this trial deliver encouraging results, Brilacidin’s treatment of ulcerative colitis and Crohn’s disease likely would be warranted.”