Angion Halts Phase II Kidney Fibrosis Trial to Explore "Strategic Alternatives"

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Angion Biomedica has announced plans to consider potential mergers, reverse mergers, asset sales, licensing and the like as it pursues activities that would preserve and increase shareholder value. 

One of the biggest moves in this plan is discontinuing the development of ANG-3070 for all indications and halting most of its ongoing development programs. The goal is to preserve as much as the $60 million it has in cash and cash equivalents as of the year's second quarter. With Oppenheimer & Co as its exclusive financial advisor, the company is looking for ways to increase share value through any feasible strategic transaction. 

The company has not settled on a specific activity and is still exploring its options. The goal is to reduce cash burn as fast as possible.

ANG-3070 is a highly-selective oral tyrosine kinase receptor inhibitor designed to treat kidney and lung fibrosis. It is currently enrolling for its Phase II trial, which will evaluate its efficacy and safety in patients with primary proteinuric kidney diseases. 

The other preclinical programs that it might sunset soon involve a rho kinase 2 (ROCK2) inhibitor for fibrosis and a CYP11B2 (aldosterone synthase) inhibitor for dysregulated aldosterone diseases, including Conn's Syndrome, congestive heart failure, refractory hypertension and kidney fibrosis. 

"Angion's management and Board of Directors have moved quickly begin exploring strategic alternatives as the best option for enhancing and preserving shareholder value," Dr. Jay Venkatesan, the president and chief executive officer of Angion, said in a statement. 

The company announced plans to stop its Phase II JUNIPER dose-finding trial for ANG-3070 in late June. The study, which started enrolling participants in December 2021, was discontinued due to patient safety issues after the company reassessed its risk/benefit profile. One of the patients in the drug's treatment arm experienced an unexpected and substantial decline in kidney function. Angion has already started alerting clinical trial sites and regulatory authorities about 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," Venkatesan noted in an earlier announcement. 

"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," added Venkatesan. 

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