Benzinga | Oct 14, 2021 09:06AM EDT

First Wave BioPharma Announces Dosing Of First Patient In Phase 2b Clinical Trial Evaluating Topical Niclosamide In Patients With Ulcerative Proctitis And Ulcerative Proctosigmoiditis

First Wave BioPharma, Inc., (NASDAQ:FWBI), ("First Wave BioPharma" or the "Company"), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has dosed the first patient in a Phase 2b clinical trial investigating a topical formulation of niclosamide (FW-UP) as a potential treatment for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). The trial formally launches the expansion of the company's clinical development program for niclosamide into indications for inflammatory bowel diseases.



UP and UPS are two types of ulcerative colitis, a chronic inflammatory bowel disease (IBD) consisting of fine ulcerations in the inner mucosal lining of the large intestine that do not penetrate the bowel muscle wall. UPS causes inflammation in the colon and rectum, while UP is confined only to the rectum.

"With the first patient now dosed in our Phase 2b clinical trial of FW-UP, we are a step closer to bringing forth a potentially new therapeutic option for people suffering from UP and UPS, debilitating GI diseases that often impact young children and the elderly and for which there is no cure," stated James Sapirstein, President and CEO of First Wave BioPharma. "Following our recent acquisition of First Wave Bio, our development program for niclosamide has expanded to multiple ulcerative colitis indications, which represent a significant and growing patient population. In the U.S. last year, it is estimated that there were more than 825,000 ulcerative colitis diagnoses, with the market for ulcerative colitis, UP and UPS estimated at approximately $5 billion annually. These are just a few of the IBD indications where we believe our proprietary formulations of niclosamide could provide potentially attractive treatment options given that they have a known safety profile, are non-systemic, and could reduce or eliminate entirely the need of steroids and immunomodulators."

The Phase 2b trial is a placebo-controlled study that will enroll up to 28 patients to compare FW-UP, administered as an enema twice daily at a dose of 450 mg, to placebo enemas twice daily. Patient screening is underway at clinical trial sites in Italy and will start soon in Austria and Germany. First Wave BioPharma is also planning a separate clinical trial to investigate an oral formulation of niclosamide as a potential treatment for pancolitis.

The Phase 2b trial builds on preliminary data from a previous Phase 1b trial evaluating a low-dose (150 mg/twice daily) and a Phase 2a high-dose (450 mg/twice daily) of FW-UP in patients with UP and UPS. Data from the first 17 patients treated in the low-dose cohort demonstrated niclosamide to be well tolerated, with a durable therapeutic effect and a clinical remission rate of 59%. Although these initial trial results are based upon early stage data, this rate of remission compares favorably to the rates of 38% to 44% reported for the commonly used steroid, budesonide. In data collected from the first four patients in the high-dose cohort, niclosamide was also shown to be well tolerated.

Giovanni Monteleone, M.D., primary investigator for the trial and a gastroenterologist at the University of Rome Tor Vergata, stated, "Small molecule drugs, and in particular niclosamide, represent one of the most interesting potential advances in the treatment of IBDs. Niclosamide can be administered without the use of needles and can be formulated to target the area of GI tract where disease-causing inflammation occurs. Moreover, niclosamide offers the potential to avoid the systemic complications sometimes caused by steroids and other immunosuppressants. The data from the previous clinical trial provided the first proof of principle for niclosamide as a treatment for IBD, and now with this new Phase 2b trial underway, we hope to determine whether patients will achieve better results from higher doses of the drug."