Entero Therapeutics chairman issues letter to stockholders

Entero Therapeutics released a letter from James Sapirstein, the Company’s Chairman and CEO, to provide stockholders with a business update. “We are making substantial progress in the development and on the regulatory pathways with our lead product candidate, latiglutenase, a late-stage clinical asset for the treatment of celiac disease. Our primary focus is on advancing latiglutenase into a pivotal Phase 3 trial in 2025. Our recent regulatory agency interactions and operational changes outlined below reflect our sharp focus on positioning Entero for success with this lead program that can potentially address the unmet treatment needs for the millions of people currently struggling with celiac disease. After reviewing previous results from the Phase 2b clinical trial of latiglutenase, we decided to submit two Type D meeting requests to the FDA to build a more precise and efficient Phase 3 clinical trial design and development plan for latiglutenase… Additionally, we are preparing a response to the most recent end of Phase 2 and Type C meeting correspondence with the FDA to propose an updated protocol and streamlined trial design with the single-dose regimen and a focus on the most severe and symptomatic patient population demonstrating intestinal damage… Despite the challenging market conditions affecting all clinical-stage biopharma companies, we completed a small financing that generated $1.9 million in gross proceeds to help support our movement toward initiation of the Phase 3 trial.”