(Boursier.com) — First Wave BioPharma soared this Wednesday on Wall Street by 163% to $9.70, after the group agreed to sell its drug against inflammatory bowel diseases… The clinical-stage biopharmaceutical company specializing in the development of therapies targeted and non-systemic treatments for gastrointestinal (GI) diseases announced today that it has entered into a non-binding terms agreement to sell its Niclosamide program for the treatment of inflammatory bowel diseases (IBD) such as ulcerative colitis and conditions associated with an undisclosed biopharmaceutical company.
The proposed transaction will allow First Wave BioPharma to focus its development resources on its three late-stage clinical programs: Capeserod, a selective 5-HT4 receptor partial agonist licensed from Sanofi ; Adrulipase, a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) and, following the closing of the recently announced potential business combination with ImmunogenX, Latiglutenase, a Phase 3-ready oral biotherapeutic for celiac disease.
7 digits
The list of non-binding terms includes a 7-figure upfront payment to First Wave BioPharma for the rights to niclosamide, as well as economics related to future milestones and royalties. The transaction is expected to be finalized in the first half of 2024.
Additional details of the transaction will be disclosed upon completion and signing of the definitive agreement… Upon signing of the definitive agreement, completion of the transaction will be subject to, among other things, the satisfaction of the conditions negotiated therein, upon the purchaser obtaining adequate financing and upon receipt of all third party (including governmental) approvals, licenses and consents, and authorizations, where applicable…
“This is a very exciting time in the evolution of First Wave BioPharma, as we recently reinvigorated our gastrointestinal-focused clinical development pipeline with Sanofi’s Phase 2-ready Capeserod and imminent addition of Latiglutenase ready for phase 3,” said James Sapirstein, President and CEO of First Wave BioPharma. “We plan to rapidly advance these programs in 2024 given the significant potential of each to treat gastrointestinal conditions for which there are currently no effective treatments. As a result, we have made the strategic decision to streamline our pipeline of development and are pleased to have entered into a non-binding term sheet for Niclosamide, which has the potential to inject additional non-dilutive capital into First Wave.”
Non-steroidal anti-inflammatory treatment
Niclosamide is a prescription, non-systemic, small molecule medication listed as an essential medicine by the World Health Organization (WHO). Niclosamide was approved by the United States Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections and has been used safely in millions of patients. The drug is a potential nonsteroidal anti-inflammatory therapy for the treatment of mild to moderate inflammatory bowel disease (IBD).
First Wave BioPharma previously conducted phase 2 trials with niclosamide for the treatment of ulcerative proctitis/proctosigmoiditis (the most common form of ulcerative colitis) and for the treatment of COVID gastrointestinal infections… The company has also of an open-label Phase 2 IND for the treatment of colitis and diarrhea associated with immune checkpoint inhibitors in patients with metastatic cancer. The intellectual property of niclosamide formulations governing the composition of materials and methods of use extends beyond 2040…