First Wave BioPharma Announces Dosing of First Patient in Phase 2b Clinical Trial Evaluating Topical Niclosamide in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis

Rhea-AI Summary

First Wave BioPharma has initiated a Phase 2b clinical trial for its topical formulation of niclosamide (FW-UP) targeting ulcerative proctitis and ulcerative proctosigmoiditis. This trial follows favorable results from Phase 1b, where niclosamide exhibited a clinical remission rate of 59%, outperforming the steroid budesonide's 38-44%. With over 825,000 ulcerative colitis cases in the U.S. annually, the market potential is approximately $5 billion. The trial will include up to 28 participants across clinical sites in Italy, Austria, and Germany.

Positive

• Initiation of Phase 2b trial for niclosamide targeting ulcerative proctitis and ulcerative proctosigmoiditis.
• Previous Phase 1b data showed a 59% remission rate with niclosamide, better than budesonide.
• Estimated market potential for ulcerative colitis treatments is around $5 billion annually.

Negative

• None.

Previous Phase 1b clinical data suggest niclosamide delivers favorable efficacy compared to topical corticosteroid in the treatment of ulcerative proctitis and ulcerative proctosigmoiditis

BOCA RATON, Fla., Oct. 14, 2021 (GLOBE NEWSWIRE) -- 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.”

About Niclosamide
Niclosamide is a prescription small molecule drug known for its anti-inflammatory and anti-viral properties. Listed as an essential medicine by the World Health Organization (WHO), niclosamide has been safely used on millions of patients for other clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections.

About FW-UP
FW-UP is a niclosamide-based, small molecule anti-inflammatory inhibitor therapy for the treatment of ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). A Phase 1b/2a clinical trial evaluated the safety and potential efficacy of a topical rectal formulation of FW-UP in patients with UP and UPS, and First Wave BioPharma has advanced the compound into a Phase 2b trial.

About Ulcerative Proctitis and Ulcerative Proctosigmoiditis
Ulcerative proctitis and ulcerative proctosigmoiditis 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. Symptoms include weight loss, fatigue, abdominal pain and cramps, rectal pain and bleeding, and diarrhea, although constipation can also develop as the body struggles to maintain normal bowel function. UP and UPS can occur at any point throughout life, with a high occurrence in young children and then again around 40-50 years of age. Progression of this disease to ulcerative colitis, extending farther up the bowel to involve the sigmoid colon, occurs in about 30-50% of patients. Although there is a range of treatments to help ease symptoms and induce remission, there is no cure.

About First Wave BioPharma, Inc.
First Wave BioPharma, Inc. is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. First Wave BioPharma is currently advancing a therapeutic development pipeline populated with multiple clinical stage programs built around its two proprietary technologies – niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. First Wave BioPharma’s niclosamide portfolio is led by three clinical programs: FW-COV, for COVID-19 gastrointestinal infections; FW-UP, for ulcerative proctitis (UP) and ulcerative proctosigmoiditis; and FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients. Two additional formulations of niclosamide, FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease) are expected to enter the clinic in 2022 and 2023, respectively. First Wave BioPharma is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.firstwavebio.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition and its announcement on the Company’s business, operating results and financial prospects; the integration of the First Wave Bio, Inc. business with the Company’s own business; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@firstwavebio.com

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett / David Schemelia / Ingrid Mezo
(212) 375-2665 / (609) 468-9325 / (646) 604-5150
jbennett@tiberend.com / dschemelia@tiberend.com / imezo@tiberend.com

FAQ

What is the purpose of the Phase 2b trial for FWBI?

The Phase 2b trial aims to evaluate the efficacy of the FW-UP topical formulation of niclosamide in treating ulcerative proctitis and ulcerative proctosigmoiditis.

What were the results of the previous Phase 1b trial for FW-UP?

The Phase 1b trial reported a clinical remission rate of 59% for niclosamide, which is higher than that of the commonly used steroid budesonide.

Where is the Phase 2b trial for niclosamide being conducted?

The Phase 2b trial is being conducted in Italy, with plans to begin in Austria and Germany.

What is the market size for ulcerative colitis treatments?

The market for ulcerative colitis treatments, including ulcerative proctitis and ulcerative proctosigmoiditis, is estimated to be approximately $5 billion annually.