Last patient completes last visit in Adrulipase Phase 2 clinical trial

BOCA RATON, Fla., July 05, 2023 (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 James Sapirstein, Chairman, President and CEO of First Wave BioPharma, has issued a Letter to Stockholders providing an update on the Company’s clinical programs and recent events. The full text of the letter follows.


To my fellow stockholders,

We reach the midpoint of 2023 following a very productive first six months of the year during which the Company made considerable progress with our Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Last week we announced the completion of all patient dosing, which is a key milestone ahead of expected topline data in July. We are pleased to announce that the last patient in the study has completed their last visit.

Initiating a Phase 2 clinical trial and completing patient dosing in less than six months is a tribute to our clinical team, the investigators, and trial sites. It also highlights the dedication of the patients who participated in the study, and the greater CF community, in advocating for new therapeutic options that better address the numerous, debilitating symptoms of CF.   According to the Cystic Fibrosis Foundation, there are approximately 40,000 patients in the U.S. with EPI caused by cystic fibrosis and approximately 95,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation.

Phase 2 SPAN Trial Topline Data Expected in July

The Phase 2 SPAN clinical trial is a multi-center study designed to investigate the safety, tolerability and efficacy of our enhanced formulation of adrulipase in a titrated dose-escalation study involving thirteen (13) patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption (CNA).

If successful, we believe adrulipase has the potential to supplant porcine PERT as the standard of care for EPI associated with CF in an estimated $2.2 billion global market. Given this, our plan is to proceed to a Phase 3 registration trial following the expected topline data readout in July. The first step in this process would be scheduling an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which we would aim to secure in the fourth quarter of 2023.

Ultimately, our goal is to advance the adrulipase program towards a Biologics License Application (BLA) and potential future commercialization. We believe our enhanced formulation of adrulipase has the potential to be a best-in-class treatment for EPI. Our formulation is designed to offer improved protection against the acidic pH in the stomach followed by the rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit. The enhanced formulation also has the potential to significantly decrease the number of pills a patient would need to take to achieve the desired therapeutic effect. The pill burden for current commercial porcine PERT can be as high as 40 capsules per day, creating a substantial challenge for EPI patients.

We have also continued to strengthen the intellectual property (IP) protection for adrulipase, including the recent publication of two patent applications for composition of matter and methods of use claims governing the enhanced enteric microgranule delivery formulation. The two applications were published by both the United States Patent and Trademark Office (USPTO) and the International Bureau of the World International Patent Organization (WIPO) under the Patent Cooperation Treaty (PCT). Overall, our IP protection for adrulipase extends into the 2042-2043 timeframe.
Shareholder Meeting Update

On June 22, 2023, First Wave held its 2023 Annual Meeting of Stockholders (the “Annual Meeting”) during which stockholders had the opportunity to vote on five proposals. We are pleased to report that all proposals passed, including the re-election of five members to our board of directors. Maintaining continuity of leadership during this important phase of growth for the Company is critically important, and we are grateful for the ongoing support of our stockholders.

Strengthening of Balance Sheet

The biotechnology sector continues to face headwinds, which have impacted stocks of all sizes and restricted access to capital. Despite the current difficult market conditions, we have raised a total of $6.4 million so far in 2023. This has strengthened our balance sheet as we continue to focus capital expenditures on the advancement of the adrulipase program, which we believe has the potential to generate near term and ongoing value for our stockholders.

Nearing Multiple Potential Inflection Points

The topline data from the Phase 2 SPAN clinical trial is one of several inflection points that First Wave anticipates over the coming quarters that have the potential to transform the Company and deliver positive returns for stockholders. This is an exciting time, and we look forward to the many opportunities in front of us as we advance our mission to bring relief to patients living with the often painful, dangerous and discomforting symptoms tied to GI disease, to protect their health and to restore their quality of life.

As always, I extend my appreciation to our stockholders for your continued support.

James Sapirstein
Chairman, President and CEO
First Wave BioPharma, Inc.   

About Adrulipase 
Adrulipase is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase is derived from the Yarrowia lipolytica yeast lipase and is designed to break up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge, and weight loss. There are approximately 40,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 95,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation.

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 – the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-inflammatory properties. First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). In developing adrulipase, First Wave is seeking to provide CF and CP patients with a safe and effective therapy to control EPI that is non-animal derived and offers the potential to dramatically reduce their daily pill burden. The company is also advancing multiple programs involving niclosamide, including FW-UP for ulcerative proctitis and ulcerative proctosigmoiditis, FW-UC for ulcerative colitis, and FW-CD for Crohn’s disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit

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; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; 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, the related settlement and their effect on the Company’s business, operating results and financial prospects; 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, 2022 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

Media contact:
Tiberend Strategic Advisors, Inc.
David Schemelia
(609) 468-9325

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777 Yamato Road
Suite 502
Boca Raton, FL 33431
(561) 589-7020