First Wave BioPharma, Inc. - FWBI STOCK NEWS

First Wave BioPharma (NASDAQ:FWBI) announced the dosing of its first patient in the Phase 2 SPAN clinical trial, targeting enhanced delivery of adrulipase for treating exocrine pancreatic insufficiency (EPI) in cystic fibrosis patients. This significant milestone aims to potentially replace porcine-based therapies with a new non-animal derived solution. The trial will assess the safety and efficacy of the new formulation in 12 patients, with topline results expected by mid-2023.

The study's primary endpoint focuses on the coefficient of fat absorption (CFA) while also evaluating other health indicators. This trial represents a pivotal step for First Wave BioPharma in providing improved treatment options for EPI.

First Wave BioPharma, a clinical-stage biopharmaceutical company, has announced that CEO James Sapirstein will participate in a fireside chat at the 35th Annual Roth Conference on March 13, 2023. The event will take place from 1:00-1:25 p.m. PST at the Ritz Carlton, Laguna Niguel, California. During the conference, Sapirstein will discuss the company's gastrointestinal disease therapies and engage in one-on-one meetings with investors to showcase its clinical development strategy and achievements. A live webcast of the chat will also be available on the company’s website.

First Wave BioPharma (NASDAQ:FWBI) announced that an abstract on its adrulipase treatment for exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients has been accepted for presentation at the 2023 Digestive Disease Week Conference (DDW 2023) from May 6-9, 2023. The study focuses on the safety and efficacy of adrulipase combined with standard porcine pancreatic enzyme replacement therapy (PERT). Topline results from the ongoing Phase 2 SPAN trial, exploring adrulipase as a monotherapy, are expected by mid-2023. The therapy aims to enhance fat absorption, critical for patients suffering from EPI.

First Wave BioPharma (NASDAQ:FWBI) issued an update from CEO James Sapirstein detailing the company's progress and outlook for 2023 following a challenging year for biotech firms. They have initiated a Phase 2 trial for adrulipase, targeting exocrine pancreatic insufficiency linked to cystic fibrosis and chronic pancreatitis, with topline data expected mid-2023. The trial focuses on a new enteric microgranule formulation aimed at reducing pill burden for patients. The company also regained compliance with Nasdaq regulations, enhancing its access to public markets. First Wave aims to address a $2.2 billion market with adrulipase and improve patients’ quality of life.

First Wave BioPharma (FWBI) announced on February 6, 2023, that it has regained compliance with Nasdaq's minimum bid price requirement, concluding the Nasdaq Hearing Panel's oversight process. This follows the company achieving compliance with the minimum stockholders' equity requirement after raising approximately $2.5 million in a private placement on November 22, 2022. The continuation of its Nasdaq listing is crucial for enhancing the company’s growth strategy and increasing investor awareness.

First Wave BioPharma (NASDAQ:FWBI) has initiated patient screening for its Phase 2 SPAN clinical trial targeting exocrine pancreatic insufficiency (EPI) in cystic fibrosis patients. Dosing is expected to start in mid-February, with topline results anticipated by mid-2023. The study will evaluate the safety, tolerability, and efficacy of a new enteric microgranule formulation of adrulipase, a recombinant lipase enzyme. The trial aims to enroll 12 patients and focuses on improving daily symptom management for chronic pancreatitis and cystic fibrosis patients. Previous therapies have been animal-derived, highlighting the significance of this non-animal alternative.

First Wave BioPharma (FWBI) announced the initiation of a Phase 2 clinical trial for an enhanced enteric microgranule delivery formulation of adrulipase, targeting exocrine pancreatic insufficiency (EPI) in cystic fibrosis patients. The FDA has reviewed the amended IND with no further comments. This open-label study aims to assess the safety and efficacy of adrulipase in a 12-patient cohort, with primary efficacy assessed through the coefficient of fat absorption (CFA). Patient screening begins in early February 2023, with topline data expected by mid-2023. The new formulation aims to reduce pill burden for patients, which can be as high as 40 capsules a day.

First Wave BioPharma (NASDAQ: FWBI) announced that James Sapirstein, Chairman, President, and CEO, will present at the BIO CEO & Investor Conference on February 6, 2023, at the Marriott Marquis in New York City. The presentation is scheduled for 9:30 a.m. EST in the Winter Garden Room. The management team will hold one-on-one meetings with investors to discuss the company's business strategy, recent achievements, and future milestones. First Wave develops targeted therapies for gastrointestinal diseases, with ongoing clinical programs for conditions like exocrine pancreatic insufficiency and ulcerative colitis.

First Wave BioPharma (NASDAQ: FWBI) announced the filing of a U.S. Provisional Patent application to improve the delayed release profile of adrulipase, enhancing its intellectual property portfolio. This follows their recent IND amendment submission to the FDA for a Phase 2 clinical trial of an enhanced enteric microgranule formulation targeting exocrine pancreatic insufficiency (EPI) in cystic fibrosis and chronic pancreatitis patients. The new formulation aims to reduce pill burden significantly, potentially improving patient compliance. The company is focused on developing non-systemic therapies for gastrointestinal diseases.