Axcella Completes Enrollment of Subjects in AXA1665-002 Study
- 60 subjects enrolled in AXA1665-002
- Top-line data expected in mid-2020
- IND submission for overt hepatic encephalopathy and initiation of potential registrational Phase 2b/3 clinical trial planned for second half of 2020
“We continue to be pleased by the speed at which we have been able to enroll subjects in our clinical studies, including AXA1665-002. We believe this is due in large part to the motivation of investigators to work with us and their intrigue about the potential impact of our EMM compositions,” said
Axcella plans to investigate AXA1665 as an oral product candidate for overt hepatic encephalopathy, a disease that is associated with amino acid imbalance, dysregulated ammonia metabolism, and muscle wasting.
About Endogenous Metabolic Modulators (EMMs)
EMMs are a broad family of molecules, including amino acids, that regulate human metabolism. Axcella is developing a range of novel product candidates that are comprised of multiple EMMs engineered in distinct combinations and ratios to simultaneously impact multiple metabolic pathways to modify the root causes of various complex diseases and improve health.
About Axcella’s Ongoing Clinical Studies
Each of the company’s ongoing clinical studies are being conducted as non-investigational new drug (IND) application clinical studies under
Internet Posting of Information
Axcella uses its website, www.axcellahealth.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the company’s website in the “Investors and News” section. Accordingly, investors should monitor such portions of the company’s website, in addition to following its press releases,
Axcella is a clinical-stage biotechnology company focused on leveraging endogenous metabolic modulators (EMMs) to pioneer a new approach for treating complex diseases and improving health. The company’s product candidates are comprised of EMMs and their derivatives that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. Axcella’s pipeline includes lead therapeutic candidates for non-alcoholic steatohepatitis (NASH) and the prevention of recurrent overt hepatic encephalopathy (OHE). Additional muscle- and blood-related programs are in earlier-stage development. For more information, please visit www.axcellahealth.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the development potential of the company’s EMM product candidates, including AXA1665, to impact dysregulated metabolism and benefit individuals with complex diseases, the potential of AXA1665 to benefit patients with OHE, the timing of the company’s ongoing clinical studies and planned IND-enabled clinical trials and the timing of receipt and disclosure of data from the same. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any 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 materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the breadth and potential uses of the company’s pipeline of product candidates, including the potential for AXA1665 to benefit OHE patients, whether planned data readouts and disclosures are positive and support our believes regarding EMMs and AXA1665’s potential ability to benefit not just healthy but also diseased patients, including patients with OHE, and the planned timing of our disclosures regarding data readouts, whether data readouts and/or FDA feedback support our planned timing for an IND filing, clinical trial design and target indication for AXA1665, the strength of the AXA Development Platform, the efficiency of the company’s discovery and development approach, the clinical development and safety profile of the company’s product candidates and their health or therapeutic potential, whether and when, if at all, the company’s product candidates will receive approval from the