First Wave BioPharma comes ashore with new name as it prepares for phase 3 trial

2024-05-17

临床2期临床3期上市批准

First Wave BioPharma comes ashore with new name as it prepares for phase 3 trial

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来源: FiercePharma

In tandem with its makeover this week—which happened to occur during Celiac Awareness Month—Entero teamed up with patient advocacy organization Celiac Journey to put up a display raising awareness around celiac disease on the Nasdaq Tower in Times Square on Thursday.

The company formerly known as First Wave BioPharma has found itself on dry land with a decidedly non-aquatic new moniker.

The gastrointestinal disease-focused biotech will henceforth be known, fittingly, as Entero Therapeutics, it announced Thursday. The rename comes with a new logo, website and, as of Friday, stock ticker: Entero will now trade on the Nasdaq as “ENTO.”

“The rebranding aligns our corporate identity with our mission of bringing to market new treatments for the gut and intestine,” CEO James Sapirstein said in the announcement.

“We have accelerated this by adding latiglutenase to our pipeline. This is an opportunity to address significant medical need and market opportunity for celiac disease,” he continued. “As we prepare for a Phase 3 study with this program and advance our other drug candidates, we want to make sure that our branding better reflects the Company’s GI focus.”

Entero picked up latiglutenase in the recent merger between First Wave and ImmunogenX. The all-stock transaction was finalized in mid-March, when the combined company then known as First Wave also laid out its plans to license the biotherapeutic’s U.S. and Canada commercial rights to “a strategic global pharmaceutical company” and raise additional financing to fund its continued development, all of which it said are expected to close in the second half of this year.

The FDA’s GI division has already reviewed the phase 3 trial plan for latiglutenase, according to the company, with the study set to begin early next year. Entero is aiming to be the first to win approval for a pharmacologic treatment for celiac disease.

Aside from latiglutenase, Entero is also developing two other GI-related phase 2 assets. Last fall, it paid $500,000 up front to take over development of Sanofi’s capeserod, which the French pharma had previously tested in Alzheimer’s disease and urinary incontinence, but which Entero plans to apply to multiple gastrointestinal disorders, starting with gastroparesis.

Meanwhile, Entero is developing adrulipase as a treatment for exocrine pancreatic insufficiency in patients with cystic fibrosis and chronic pancreatitis. Though Entero has positioned the yeast-based formulation as a potential alternative to AbbVie’s Creon and other pig-derived pancreatic enzyme replacement therapies in the space, adrulipase was set back last summer by preliminary results of a small phase 2 trial in CF patients, in which “it is likely the primary efficacy endpoint was not achieved,” the company said at the time.

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