First Wave BioPharma Files U.S. and PCT Patent Applications for Niclosamide in Long-Haul COVID-19

Rhea-AI Summary

First Wave BioPharma (FWBI) announced the enhancement of its intellectual property for niclosamide to treat COVID-19-related gastrointestinal infections. The company filed U.S. Patent and PCT applications for using niclosamide to treat long haul COVID-19 syndrome. Niclosamide, an established anti-inflammatory and antiviral drug, is being developed as FW-COV, with a Phase 2 trial underway to evaluate its effectiveness against SARS-CoV-2 in patients with acute infections. Top-line results are anticipated in the first half of 2022.

Positive

• Improvements in intellectual property portfolio for niclosamide with filings of U.S. and PCT applications.
• FW-COV in Phase 2 trials shows potential as a treatment for COVID-19 related GI symptoms.
• Expected top-line data reporting in H1 2022 could positively influence market perception.

Negative

• Potential uncertainty surrounding trial outcomes may affect investor confidence.
• No approved treatments currently exist for long-haul COVID-19-related GI symptoms.

BOCA RATON, Fla., March 28, 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, today announced the continued enhancement of the intellectual property (IP) portfolio governing niclosamide as a treatment for COVID-19-related GI infections. The Company has filed U.S. Patent and Patent Cooperation Treaty (PCT) applications entitled “Treatment of Long Haulers Syndrome with Niclosamide” (U.S. Application No. 17/703,626 and PCT Application No. PCT/US22/21736).

Niclosamide is a widely prescribed small molecule with anti-inflammatory and antiviral properties that has been safely used on millions of people worldwide. First Wave BioPharma is developing a proprietary oral formulation of niclosamide, FW-COV, as a treatment for COVID-19-related GI infections. A Phase 2 clinical trial, RESERVOIR, is investigating the safety of FW-COV and its ability to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract in patients with acute COVID-19-related GI infections. First Wave BioPharma expects to report top-line data in the first half of 2022.

The PCT application, filed with the PCT receiving office at the U.S. Patent & Trademark Office (USPTO), covers methods of treating patients with multiple formulations of niclosamide for GI infections related to post-acute COVID-19 syndrome, also known as “long haul” COVID-19, in most major market countries throughout the world. The U.S. non-provisional patent application was also filed with the USPTO, and like the PCT application, relates to the use of niclosamide as a treatment for long haul COVID-19-related GI infections. Any resultant patents from these filings will have an estimated term of until at least 2042.

“We believe this an important step to enhancing the intellectual property portfolio protecting FW-COV as we advance its development as a potential treatment for the millions of people suffering from the discomforting and debilitating GI symptoms caused by the SARS-CoV-2 virus,” said James Sapirstein, President and CEO of First Wave BioPharma. “Despite vaccination programs here and abroad, COVID-19 remains a pernicious disease, and ‘long haul’ COVID-19 has developed into a major medical issue. The World Health Organization estimates that 100 million people worldwide are now or have suffered from long haul COVID, and in the U.S. figures show that it has affected one-in-seven working adults. Of those patients, millions are believed to suffer long haul GI symptoms.”

Mr. Sapirstein continued, “Mounting evidence suggests the SARS2 virus often hides in the GI tract, forming reservoirs and causing illness long after the initial infection has abated, and unfortunately, there are no approved treatments for these patients. We believe that FW-COV has the potential to remove the virus from the GI tract and dampen inflammation secondary to an acute infection of the COVID-19 virus.”

About Acute and Long Haul COVID-19 Gastrointestinal Infections

Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases.¹ Of the approximately 80 million individuals who are reported to have contracted COVID-19 in the U.S.,² this would translate into over 14 million patients having GI infection. Of the 477 million cases reported globally,² it would translate into almost 86 million patients. Furthermore, approximately 10% of patients who were infected with COVID have persistent symptoms months after their initial diagnosis.³ Approximately 86% of these COVID “long haulers” are reported to have GI infection symptoms, with 60% continuing to have diarrhea months after their initial infection.⁴

About Niclosamide

Niclosamide is a prescription small molecule drug 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. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties. There remains an urgent need to develop new medicines that can be manufactured at a large scale quickly to treat COVID-19 and long haul COVID-19.

FW-COV

FW-COV is First Wave BioPharma’s proprietary formulation of niclosamide which the Company is testing in clinical trials as a potential anti-viral for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections. The Company’s FW-COV formulation is an oral immediate-release tablet. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids which the Company believes may allow local niclosamide concentrations to reach anti-viral and anti-inflammatory levels. The Company believes that FW-COV has the potential to benefit COVID patients by decreasing viral load in the GI tract, treating infection symptoms, and preventing transmission of the virus through fecal spread.

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

References:
¹ Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 2020
² New York Times. (3/25/22) https://www.nytimes.com/interactive/2021/world/coronavirus-maps.html
³ Rubin, R. “As their numbers grow, COVID-19 “Long Haulers” Stump Experts”. https://jamanetwork.com/journals/jama/fullarticle/2771111 September 23, 2020.
⁴ Davis, et al. “Characterizing Long Covid in an International Cohort: 7 Months of Symptoms and their Impact”. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v2.full.pdf

FAQ

What is the recent press release from First Wave BioPharma regarding FWBI?

First Wave BioPharma announced new patent applications for niclosamide aimed at treating COVID-19-related gastrointestinal infections and long haul COVID-19.

What is FW-COV and its significance in the press release?

FW-COV is First Wave BioPharma's proprietary oral formulation of niclosamide, currently undergoing Phase 2 trials to treat COVID-19-related GI infections.

When can we expect data from the Phase 2 trials for FW-COV?

Top-line data from the Phase 2 clinical trial for FW-COV is expected to be reported in the first half of 2022.

How does niclosamide relate to long haul COVID-19 according to the press release?

Niclosamide has been proposed as a treatment for long haul COVID-19-related GI infections, as highlighted in First Wave BioPharma's recent patent filings.

What are the potential market implications of First Wave BioPharma's press release for shareholders of FWBI?

The enhancement of the intellectual property portfolio and upcoming trial results could positively impact investor interest and stock performance for FWBI.