Angion Announces Discontinuation of Phase 2 Trial of ANG-3070 in Patients with Primary Proteinuric Kidney Disease

Rhea-AI Summary

Angion Biomedica Corp. (NASDAQ:ANGN) announced the discontinuation of its JUNIPER Phase 2 trial for ANG-3070, an oral TKI targeting primary proteinuric kidney diseases, due to patient safety concerns. A reassessment revealed a significant decline in kidney function in a participant, prompting the decision to safeguard patient health. Despite the unmet medical need, Angion will deprioritize ANG-3070 for serious kidney conditions while evaluating its potential for idiopathic pulmonary fibrosis. The company expects over $60 million in cash and equivalents by the end of Q2.

Positive

• Angion expects to report cash and cash equivalents of greater than $60 million at the end of the second quarter.
• The decision to deprioritize ANG-3070 in serious kidney diseases allows focus on other potential therapies.

Negative

• Discontinuation of the JUNIPER trial raises concerns over ANG-3070's safety and efficacy for kidney diseases.
• Unexpected significant decline in kidney function observed in trial participants indicates serious risks.

UNIONDALE, N.Y., June 29, 2022 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (NASDAQ:ANGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address fibrotic diseases, today announced the discontinuation of JUNIPER, its Phase 2 dose-finding trial of ANG-3070, an oral tyrosine kinase inhibitor (TKI), in patients with primary proteinuric kidney diseases, specifically focal segmental glomerulosclerosis (FSGS) and immunoglobulin A nephropathy (IgAN). This trial, which began enrolling patients in December 2021, is being discontinued in the interest of patient safety based upon a reassessment of the risk/benefit profile of ANG-3070 in patients with established serious kidney disease.

This reassessment was conducted following the occurrence of a potential safety signal of an unexpected and substantial decline in kidney function in a patient in the trial’s drug treatment arm and took into account a number of factors, including an evaluation of the totality of the data Angion has reviewed with respect to ANG-3070, known TKI class side effects, including potential adverse effects on the kidney, and an analysis of the blinded patient data which did not detect any early treatment signal indicating a reduction in proteinuria. These factors collectively lead Angion to believe discontinuation of the JUNIPER study is in the best interest of patients. Angion is communicating with clinical trial sites and regulatory authorities regarding its decision to terminate the trial.

“Based on our ongoing analysis of the risk/benefit profile of ANG-3070 in patients with primary proteinuric kidney disease, we believe it to be in the best interest of patients to discontinue our Phase 2 JUNIPER study at this time, notwithstanding the significant unmet need for new therapies in this patient population,” stated Dr. Jay Venkatesan, Angion’s President and Chief Executive Officer. “We are, of course, disappointed by today’s announcement and have made the decision to deprioritize the study of ANG-3070 in patients with established serious kidney disease. We will continue to evaluate the potential of ANG-3070 as a treatment for patients with idiopathic pulmonary fibrosis, as well as to consider all strategic and operational options for Angion and its pipeline going forward.”

Angion expects to report cash and cash equivalents of greater than $60 million at the end of the second quarter.

About Angion
Angion is committed to transforming the treatment paradigm for patients suffering from fibrotic diseases for which there are no approved medicines or where existing approved medicines have known limitations. Angion’s lead product candidate is ANG-3070, a highly-selective oral tyrosine kinase receptor inhibitor. A Phase 1b trial of ANG-3070 in patients with idiopathic pulmonary fibrosis is planned to start in 2022. Additionally, Angion has preclinical programs focused on 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 the potential of ANG-3070 as a treatment for idiopathic pulmonary fibrosis (IPF), Angion’s plans to initiate a Phase 1b study of ANG-3070 in IPF in 2022, and Angion’s expectation to report cash and cash equivalents of greater than $60 million at the end of the second quarter. 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-3070 and its other product candidates; the accuracy of Angion’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 costs of clinical trials may exceed expectations; Angion’s ability to raise additional capital; and the effects of COVID-19 on Angion’s clinical programs and business operations. For a fuller description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see Angion’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the Securities and Exchange Commission on May 16, 2022, especially under the caption “Risk Factors,” as well as other documents that may be filed by Angion from time to time with the Securities and Exchange Commission. 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.

FAQ

Why was the JUNIPER trial for ANG-3070 discontinued?

The JUNIPER trial was discontinued due to a reassessment that showed a significant decline in kidney function in a participant, prioritizing patient safety.

What are the next steps for ANG-3070 after the JUNIPER trial discontinuation?

Angion will deprioritize ANG-3070 for serious kidney diseases and evaluate its potential for treating idiopathic pulmonary fibrosis.

What is ANG-3070 targeting in its clinical trials?

ANG-3070 is an oral tyrosine kinase inhibitor targeting primary proteinuric kidney diseases like FSGS and IgAN.

What financial position is Angion expecting to report?

Angion expects to report cash and cash equivalents of over $60 million at the end of the second quarter.