First Wave BioPharma Announces Poster Presentation at the 2022 Digestive Disease Week (DDW) Conference

Poster presentation to feature research involving niclosamide as a potential treatment for mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis

Boca Raton, Florida, UNITED STATES


BOCA RATON, Fla., March 03, 2022 (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, announced today that an abstract entitled, “Niclosamide Enemas, A Safe And Effective Treatment In Mild To Moderate Ulcerative Proctitis/Proctosigmoiditis: Results From An Open Label Study,” has been accepted for a poster presentation at the 2022 Digestive Disease Week Conference (DDW 2022). The conference is taking place May 21-24, 2022, in San Diego, California.

The poster, to be presented by Giovanni Monteleone, M.D., Professor and Head, Department of Gastroenterology at the University of Rome Tor Vergata, located in Rome, Italy, will share data from a Phase 1 open label study of niclosamide as a potential treatment for patients with mild to moderate ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). UP and UPS are two anatomically restricted forms of ulcerative colitis, a chronic inflammatory bowel disease (IBD) consisting of inflammation and ulcers in the colonic mucosal lining of the large intestine.

First Wave BioPharma is currently advancing a Phase 2 clinical trial investigating FW-UP, a topical formulation of niclosamide, for patients with UP and UPS. Dr. Monteleone is the primary investigator for the trial.

“The research presented by Dr. Monteleone at DDW 2022 is intended to demonstrate the potential of niclosamide as a treatment for UP and UPS and is an important touchstone for our ongoing Phase 2 clinical trial of FW-UP,” stated James Sapirstein, President and CEO of First Wave BioPharma. “Our research has demonstrated the potential for niclosamide in UP and UPS, including durable therapeutic effect and clinical remission rates above those reported for the commonly used steroid, budesonide. We look forward to building on this data to illustrate the capabilities of FW-UP and our proprietary niclosamide formulations to provide safe, non-systemic treatments for IBDs and reduce or eliminate entirely the need for steroids and immunomodulators.”

Details on the time and location of the presentation are as follows:

Presentation Title:Niclosamide Enemas, A Safe And Effective Treatment In Mild To Moderate Ulcerative Proctitis/Proctosigmoiditis: Results From An Open Label Study

Presenter:Giovanni Monteleone, M.D., primary investigator, Professor and Head, Department of Gastroenterology at the University of Rome Tor Vergata

Session Title:IBD: Controlled Clinical Trials in Humans

Date:May 24, 2022

Time:12:30 p.m. PDT - 1:30 p.m. PDT

About Niclosamide

Niclosamide is a prescription anthelminthic small molecule drug with 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. 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 under development 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 2 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 inflammation and ulcers (sores) in the mucosal lining of the large intestine. UPS causes inflammation in the sigmoid 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, occurs in about 30-50% of patients1. Although there is a range of treatments to help ease symptoms and induce remission, there is no cure.

About Digestive Disease Week® (DDW)

Digestive Disease Week is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and virtual meeting from May 21-24, 2022. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine, and technology. More information can be found at www.ddw.org.

About First Wave BioPharma, Inc.

First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline 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 two clinical programs in Phase 2 clinical trials: FW-COV for COVID-19 gastrointestinal infections and FW-UP for ulcerative proctitis (UP) and ulcerative proctosigmoiditis. Three additional indications of niclosamide, include FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients, FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease). The Company is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. First Wave BioPharma is headquartered in Boca Raton, Florida. 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.
David Schemelia
(609) 468-9325
dschemelia@tiberend.com

__________________________________
1 Gastrointestinal Society - https://badgut.org/information-centre/a-z-digestive-topics/ulcerative-proctitis/