Cambridge, MA–(business wire)– Axcella Therapeutics (Nasdaq: AXLA), a biotechnology company pioneering new approaches to treat complex diseases using multi-targeted endogenous metabolic regulator (EMM) compositions, today announced that: Its platform and current programs focused on Long COVID. The company has initiated a process to explore various strategic alternatives to maximize shareholder value and is working with its investment bank to act as a strategic advisor in this process. As part of this repositioning, and in line with current capital constraints, the company is announcing a series of organizational and program updates. This includes reprioritizing programs for COVID long-term fatigue and non-alcoholic steatohepatitis (NASH) and restructuring operations to support them. A streamlined set of priorities.
Axcella CEO Bill Hinshaw said: “We are actively accelerating business development discussions and are seeking creative collaborations to advance these innovations.”
Organization and program updates:
Axcella will reprioritize efforts to focus on the critical unmet needs and opportunities presented by Long COVID. Results from Axcella’s Phase 2a clinical trial show that AXA1125 may play an important role in the treatment of patients suffering from Long COVID. Axcella’s Phase 2a trial is the only controlled trial to demonstrate statistically and clinically relevant improvement in fatigue in Long COVID patients. Axcella is engaged in ongoing and productive reviews with US and European regulators, with the company aiming to develop its long-term COVID fatigue program into a potential registration trial.
Axcella is discontinuing its ongoing Phase 2b clinical trial of AXA1125 in NASH, but retains the option to reconsider this program should resource availability change. In September, Axcella reported positive data from a pre-planned interim analysis from his trial of AXA1125 in NASH. At 24 weeks, all subjects had a statistically significant and clinically relevant improvement in liver stiffness measure (LSM) compared to placebo in the high-dose group, as well as liver steatosis and liver stiffness. A statistically significant improvement was seen in non-invasive trials of Axcella’s preclinical and clinical data on his NASH showed relevant activity and established a remarkable safety record for AXA1125. This is what the company applied to his COVID long-term fatigue clinical trial.
Axcella has reorganized its organization to accommodate this shift in strategy and reprioritization of programs, reducing its workforce by 85% and retaining certain employees to execute strategic processes. Among the departing employees are Chief Financial Officer Bob Crane and Chief Human Resources Officer Virginia Dean.
Axcella has reached an agreement with SLR Investment Corp. (f/k/a Solar Capital Ltd.) (“SLR”) to repay its prior contract obligations.
With respect to our plans, we cannot guarantee whether a strategic transaction will be recommended by the Board and we do not intend to discuss progress regarding the evaluation process unless a transaction is approved or disclosed. Otherwise it will be suitable.
“We are extremely proud of the work of the entire Axcella team and would like to thank our talented employees for their dedication and contributions. Promising top-line trial data,” continues Hinshaw. “Repositioning the company will allow us to accelerate the development of AXA1125. We are passionate about clinical pathways for the disease COVID long-term fatigue.”
Margaret Koziel, M.D., Ph.D., chief medical officer of Axcella, said: “We believe AXA1125 has the potential to become an important first-line drug for a large, untreated patient population with long-term fatigue and NASH from COVID-19. And we are realigning our efforts to maintain the maximum value of our platform.”
About Axcella Therapeutics (Nasdaq: AXLA)
Axcella is a clinical-stage biotechnology company pioneering new approaches to treat complex diseases using compositions of endogenous metabolic regulators (EMMs). The company’s product candidates consist of EMMs and derivatives designed in different combinations and ratios to reset multiple biological pathways, improve cellular energy and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development to reduce the risk of long-term COVID, NASH and OHE recurrence. The company’s proprietary model allows him to evaluate his EMM composition through non-IND clinical trials or IND clinical trials. For more information, please visit www.axcellatx.com.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. This includes, but is not limited to, statements regarding the potential utility of AXA1125 as a treatment for Long Covid or his NASH. Comparing platforms to traditional drug discovery methods and our ability to realize benefits from strategic reprioritization and restructuring. “may”, “will”, “could”, “would”, “should”, “expect”, “plan”, “anticipate”, “intend”, ” The words “believe,” “estimate,” “project,” “project,” “probability,” “continue,” “goal,” and similar expressions are used to identify forward-looking statements. However, not all forward-looking statements contain these identifying terms. The forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ. They may differ materially from those expressed or implied by forward-looking statements. The statement contained in this press release does not state that COVID-19 relates to the potential impact on the Company’s ability to conduct and complete ongoing or planned clinical research and trials in a timely manner; Investigator recruitment or availability issues, site closures or other disruptions, and potential limitations on the quality, integrity and interpretability of data Company may collect in AXA1125 clinical trials; Other potential impacts of COVID-19 on the Company and financial results, including those relating to the ability to raise additional capital, interruptions or delays in operations, changes in laws, regulations, or interpretation and enforcement of regulatory guidance; clinical trial planning and timing; clinical trial design and whether it supports the intended indications of AXA1125; clinical development and safety profile of AXA1125 and its therapeutic potential; whether and when, if any, they will receive comparable regulatory approval, potential competition from other biopharmaceutical companies in the company’s target indications, and other risks identified in the company’s SEC filings; , which includes Axcella’s annual reports on Form 10-K, quarterly reports on Form 10-Q, and subsequent filings with the SEC. The company cautions against placing undue reliance on forward-looking statements. Axcella makes no assumptions to reflect changes in expectations or changes in events, conditions or circumstances that may underlie such statements or that actual results could differ from those set forth herein. We disclaim any obligation to publicly update or revise such statements, which may affect us. Forward-Looking Statements. The forward-looking statements contained in this press release represent the views of the company as of the date of its release and should not be relied upon as representing its views at any later date. We expressly disclaim any obligation to update any forward-looking statements.