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Innovation Readies Next Clinical Phase for Investigational IBD Therapy Brilacidin

Innovation Pharmaceuticals, a clinical-stage biopharmaceutical company, issued an update on its research program for Brilacidin, an investigational non-corticosteroid and anti-inflammatory therapy for inflammatory bowel disease (IBD).

The company is planning the next steps of Brilacidin’s clinical development after a successful Phase 2 proof-of-concept trial testing Brilacidin in patients with two localized forms of ulcerative colitis: ulcerative proctitis and ulcerative proctosigmoiditis.

The Phase 2 study showed that out of 12 patients treated with three doses of Brilacidin for six-weeks, half reached disease remission by day 42, as shown by changes in the Modified Mayo Disease Activity Index (MMDAI). Two other patients achieved partial remission. The treatment was safe and well-tolerated, with no reports of serious adverse events.

Now, Innovation plans to develop oral formulations of Brilacidin so that the therapy can reach the entire gastrointestinal tract. This will enhance Brilacidin’s ability to work as a therapy for more extended forms of IBD.

The company requested a meeting with the U.S. Food and Drug Administration to discuss several parameters for the next clinical trials to test the Brilacidin-IBD program.

Finally, research will continue to unveil the mechanisms underlying Brilacidin’s method of action, including its anti-inflammatory, immunomodulatory, and wound-healing properties. One of the targets of Brilacidin’s action is the phosphodiesterase 4 (PDE4) enzyme, which was previously shown to promote IBD.

“On the heels of a successful Proof-of-Concept study of Brilacidin in IBD, we look forward to continuing the Company’s momentum in this area,” Arthur P. Bertolino, MD, PhD, MBA, president and chief medical officer at Innovation Pharmaceuticals, said in a press release.

“Given IBD’s complex pathogenesis and variability in patient response to any one drug, new treatments are needed. More broadly, discussions remain ongoing with numerous global pharmaceutical companies, which, like us, see the considerable potential of Brilacidin as a multi-faceted drug candidate, with possible application across multiple therapeutic areas. The beauty of Brilacidin is that it was designed not only to mimic but actually to improve the body’s innate immune response—and that’s exactly what we’re now seeing translate into the clinic in the form of favorable patient outcomes,” Bertolini added.

“The results of the Brilacidin distal colitis study are exciting,” said Francis A. Farraye, MD, MSc, clinical director, Section of Gastroenterology at Boston Medical Center, professor of Medicine at Boston University School of Medicine, and scientific adviser to Innovation Pharmaceuticals.

“Brilacidin—particularly once formulated for oral delivery, offering broader coverage for more extensive forms of IBD and possibly an even greater therapeutic effect—has the potential to offer GI practitioners a novel, easily-administered therapeutic option for chronic, hard-to-treat Inflammatory Bowel Disease. I am pleased to continue my involvement with the Company as we look to advance Brilacidin into future IBD trials,” Farraye added.

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