First Wave BioPharma Begins Patient Screening for Phase 2b Clinical Trial Evaluating Niclosamide in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis

Preliminary data from prior Phase 1a/2a trial indicated safety of topical formulation of FW-UP and suggested possible favorable efficacy

First Proof of Principle for Treatment of Inflammatory Bowel Disease with Niclosamide

BOCA RATON, Fla., Sept. 28, 2021 (GLOBE NEWSWIRE) — First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma”, “First Wave”, 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 begun screening patients for enrollment in a Phase 2b clinical trial investigating a topical formulation of FW-UP as a potential treatment for ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). FW-UP is a proprietary topical formulation of niclosamide, a small molecule anti-inflammatory inhibitor therapy. 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.

“Advancing the clinical development of FW-UP in ulcerative proctitis and ulcerative proctosigmoiditis to a Phase 2b trial marks an important milestone in our niclosamide pipeline and our overarching mission to bring relief to patients living daily with gastrointestinal disease,” stated James Sapirstein, President and CEO of First Wave BioPharma. “Our recently completed acquisition of First Wave Bio added new growth opportunities in the inflammatory bowel disease space where we are exploring the use of niclosamide and its anti-inflammatory properties in several indications. Ulcerative proctitis and ulcerative proctosigmoiditis are two of several IBD indications where we believe our proprietary formulations of niclosamide could address the significant underserved needs of this very large and growing patient population.”

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.

The Phase 2b trial builds on preliminary data from a previous Phase 1a/2a trial evaluating a low-dose (150 mg/twice daily) and 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 from 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.

James Pennington, M.D., Chief Medical Officer for First Wave BioPharma, stated, “There is a great deal to be excited about with the clinical data collected thus far investigating niclosamide’s use in UP and UPS. The drug was well tolerated at both low and high doses, and the data suggest that niclosamide could be more effective than the standard of care corticosteroid. This marks the first proof of principle for niclosamide as a treatment for an IBD. Our plan with the Phase 2b study is to determine whether higher doses of niclosamide have the potential to deliver even better results for patients.”

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 is evaluating the safety and potential efficacy of a topical rectal formulation of FW-UP in patients with UP and UPS, and a Phase 2b trial has begun screening patients for enrollment.

About Ulcerative Proctitis and Ulcerative Proctosigmoiditis
Ulcerative proctitis and ulcerative proctosigmoiditis are two types of ulcerative colitis, a chronic inflammatory bowel disease 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 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’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 (UPS); and FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis (ICI-AC) and diarrhea in advanced oncology patients. Two additional formulations of niclosamide, FW-UC (for ulcerative colitis) and FW-CD (for Crohn’s disease) are expected to enter the clinic in 2022 and 2023, respectively. First Wave 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