Entero Therapeutics’ Chairman and CEO James Sapirstein Provides Business Update with Focus on Latiglutenase Development Program

Rhea-AI Summary

Entero Therapeutics (NASDAQ: ENTO) has provided a business update focusing on its lead product candidate, latiglutenase, for celiac disease treatment. The company plans to advance latiglutenase into a pivotal Phase 3 trial in 2025. Key developments include:

1. Submitting two Type D meeting requests to the FDA to optimize the Phase 3 trial design.
2. Proposing to reduce cohorts from three to two (1200 mg and placebo) to maximize efficacy and potentially reduce costs and trial duration.
3. Preparing to finalize histology-related secondary efficacy endpoints.
4. Streamlining the trial design to focus on severe and symptomatic patients with intestinal damage.
5. Completing a small financing of $1.9 million in gross proceeds.
6. Consolidating operations to the Boca Raton headquarters to reduce costs and improve efficiency.

Positive

• Advancing latiglutenase into a pivotal Phase 3 trial in 2025
• Optimizing Phase 3 trial design to potentially reduce costs and shorten trial duration
• Previous Phase 2 study results showed statistically significant histologic improvements
• Completed a small financing of $1.9 million in gross proceeds
• Consolidated operations to reduce overhead costs and improve efficiency

Negative

• Challenging market conditions affecting clinical-stage biopharma companies
• Need for additional financing to support Phase 3 trial initiation

Insights

Biotechnology Analyst

Entero Therapeutics' update on latiglutenase, their lead candidate for celiac disease, reveals strategic shifts in their clinical development approach. The company's decision to streamline the Phase 3 trial design by focusing on a single high dose (1200 mg) versus placebo is a calculated move. This adjustment could potentially accelerate the trial timeline and reduce costs, which is important for a clinical-stage biotech in the current challenging market conditions.

The emphasis on targeting the most severe and symptomatic patient population with intestinal damage is a smart strategy. It increases the likelihood of demonstrating a more pronounced treatment effect, which could strengthen the case for FDA approval. The company's proactive engagement with the FDA through Type D meetings shows a commitment to regulatory alignment, which is critical for navigating the complex approval process.

However, investors should note that while these changes appear promising, they also indicate a narrowing of focus. This could be a double-edged sword - potentially increasing the chances of success but also concentrating risk on a single approach. The $1.9 million financing, while helpful, is relatively modest and may not fully fund the Phase 3 trial, suggesting potential future dilution for shareholders.

Overall, Entero's strategic realignment demonstrates adaptability in a challenging environment, but the company's success hinges heavily on the outcome of the latiglutenase program.

Financial Analyst

Entero Therapeutics' business update reveals a company making strategic moves to conserve cash and streamline operations in a challenging biotech funding environment. The consolidation of operations to Boca Raton headquarters is a clear cost-cutting measure, which should help extend the company's runway. However, the $1.9 million raised in their recent financing is a relatively small amount for a company heading into Phase 3 trials, which typically cost tens of millions of dollars.

The focus on a single high-dose arm in the Phase 3 trial is both a risk mitigation and cost-saving strategy. By potentially reducing the number of patients needed and shortening the trial timeline, Entero could save significant capital. However, this also puts all their eggs in one basket, increasing the stakes for this single trial design.

Investors should be aware that despite these efficiency measures, Entero will likely need substantial additional funding to complete the Phase 3 trial. The company's ability to raise capital in the current market will be crucial. The stock's performance may be volatile as it will be highly sensitive to any news regarding the latiglutenase program or financing efforts.

While the strategic focus on latiglutenase could lead to faster potential commercialization if successful, it also increases the company's risk profile by limiting pipeline diversity. Shareholders should closely monitor the upcoming FDA interactions and any updates on the company's cash position.

BOCA RATON, Fla., July 31, 2024 (GLOBE NEWSWIRE) -- Entero Therapeutics, Inc., (NASDAQ: ENTO), (“Entero Therapeutics” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today released a letter from James Sapirstein, the Company’s Chairman and CEO, to provide stockholders with a business update.

LETTER FROM OUR CHAIRMAN AND CHIEF EXECUTIVE OFFICER

To my fellow stockholders,

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.

The first meeting request seeks approval to change the number of proposed cohorts in the latiglutenase Phase 3 trial from three (600 mg, 1200 mg and placebo) to two (1200 mg and placebo). Since the safety of 1200 mg of latiglutenase has been shown to be comparable to lower doses in previous Phase 2 trials, we believe the higher dose will maximize the efficacy of latiglutenase and provide us with the greatest potential to achieve success in the primary endpoint and key secondary endpoints. This adjustment should reduce the number of patients required for a Phase 3 trial and has the potential to both lower its estimated cost and shorten the time to an interim data read-out and trial completion by several months.

We also plan to submit a second Type D meeting request in the next few weeks to finalize our histology-related secondary efficacy endpoints based on previous FDA communications and recent Phase 2 study results demonstrating statistically significant histologic improvements relative to placebo using the highest doses of 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. These modifications are designed to expedite and maximize the potential success of the Phase 3 clinical trial.

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. We have also consolidated our bi-coastal operations into one office at our Boca Raton headquarters. This move streamlines processes, reduces overhead costs and creates a more cohesive work environment, enabling our team to work more efficiently and effectively toward our goals.

We thank our stockholders for their continued support and confidence. By focusing our resources and efforts on our most promising program, we are in the strongest position for near-term success, which will serve as a foundation for the advancement of latiglutenase.

Sincerely,

James Sapirstein
Chairman and CEO
Entero Therapeutics, Inc.

About Entero Therapeutics, Inc.
Entero Therapeutics 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 late-stage clinical programs built around three proprietary technologies: latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist being developed for gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. Entero Therapeutics is headquartered in Boca Raton, Florida. For more information visit www.enterothera.com.

Forward-Looking Statements
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 the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs, whether any financing or licensing transaction may be obtained, completed in an untimely manner, or not at all; whether the Company will be able to realize the expected benefits of its acquisition of ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operations acquired from ImmunogenX into the Company’s business; 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; and 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. 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, 2023, 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:
Entero Therapeutics, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@enterothera.com

Media contact:

Russo Partners
David Schull or Liz Phillips
(347) 956-7697
david.schull@russopartnersllc.com
elizabeth.phillips@russopartnersllc.com

FAQ

What is Entero Therapeutics' lead product candidate for celiac disease?

Entero Therapeutics' lead product candidate for celiac disease is latiglutenase, a late-stage clinical asset.

When does Entero Therapeutics (ENTO) plan to start the Phase 3 trial for latiglutenase?

Entero Therapeutics plans to advance latiglutenase into a pivotal Phase 3 trial in 2025.

What changes is Entero Therapeutics proposing for the latiglutenase Phase 3 trial design?

Entero Therapeutics is proposing to reduce the number of cohorts from three (600 mg, 1200 mg, and placebo) to two (1200 mg and placebo) to maximize efficacy and potentially reduce costs and trial duration.

How much financing did Entero Therapeutics (ENTO) recently secure?

Entero Therapeutics recently completed a small financing that generated $1.9 million in gross proceeds.