Topline data expected in the first half of 2021
UNIONDALE, N.Y., March 25, 2021 (GLOBE NEWSWIRE) — Angion Biomedica Corp. (NASDAQ: ANGN), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today announced completion of enrollment for its ALI-201 study, a Phase 2 trial conducted in Brazil of ANG-3777 for the reduction of severity and progression of acute lung injury in patients with COVID-19 associated pneumonia who are at high risk of progressing to acute respiratory distress syndrome, or ARDS.
To be enrolled in the trial, subjects must have been admitted to the hospital with confirmed COVID-19 disease and either require non-invasive mechanical ventilation or have insufficient blood oxygen saturation while on high flow oxygen administration. The primary endpoint is survival free from the need for mechanical ventilation or dialysis at 28 days. This trial was powered in a manner where only a very substantial improvement in the primary endpoint will result in a statistically significant outcome.
“We have preclinical data from a number of studies indicating ANG-3777 has activity in models of acute lung injury and ARDS,” commented Dr. John Neylan, Angion’s Senior Vice President and Chief Medical Officer. “This exploratory Phase 2 trial was designed to detect signals of activity for ANG-3777 in patients at high risk of ARDS in the context of COVID-19 related pneumonia. While powered only to detect a substantial improvement in the primary endpoint, we will evaluate the totality of the data for signals of efficacy and safety to help guide future development of ANG-3777 in conditions related to acute lung injury and ARDS.”
ANG-3777 is an investigational small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue and organ repair. ANG-3777 has demonstrated a substantially longer half-life than HGF and Angion believes ANG-3777 has the potential to be a first-in-class therapeutic addressing acute organ injury. Enrollment is complete in a placebo-controlled Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, and a Phase 2 exploratory trial in patients with acute lung injury associated with COVID-19 pneumonia. Enrollment is ongoing in a Phase 2 exploratory trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights outside Greater China to commercialize ANG-3777 in nephrology indications with up to $1.925 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40%. Sinovant Sciences and Angion signed a development and licensing agreement for ANG-3777 in Greater China in 2018.
Angion is committed to transforming the treatment paradigm for patients suffering from acute organ injuries and fibrotic diseases for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic currently being evaluating in a Phase 3 registration trial for delayed graft function in patients undergoing deceased donor kidney transplantation, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. Angion is also currently evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1. Additionally, Angion has preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor. For more information, please visit www.angion.com.
Forward Looking Statements
Statements contained in this press release regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this press release regarding Angion’s expectations regarding the potential safety and efficacy of ANG-3777, the potential results and outcomes of the ALI-201 study, and other studies involving ANG-3777 or other product candidates, the timing of the availability of and Angion’s disclosure of topline data from such studies. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: Angion’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ANG-3777 and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to raise additional capital; the effects of COVID-19 on the Company’s clinical programs and business operations. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see Angion’s recently filed full registration statement (including prospectus) filed with the Securities and Exchange Commission on February 4, 2021, particularly under the caption “Risk Factors.” Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
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