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-- First patient enrolled in the Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases
-- Angion will end 2021 with approximately $88.8 million in cash and cash equivalents
UNIONDALE, N.Y., Jan. 04, 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 and acute organ injuries, today provided a corporate update and announced the first patient has been dosed in its Phase 2 trial of ANG-3070, an oral tyrosine kinase receptor inhibitor, in patients with primary proteinuric kidney diseases.
ANG-3070 Program Update
Angion’s lead product candidate is ANG-3070, a highly selective oral tyrosine kinase receptor inhibitor in development as a treatment for fibrotic diseases, particularly in the kidney and lung.
Angion enrolled the first patient in its global dose-finding Phase 2 trial of ANG-3070 prior to the end of 2021. This is a randomized, double-blind, placebo-controlled trial intended to assess the safety and efficacy of ANG-3070 in adult patients with focal segmental glomerulosclerosis (FSGS) or immunoglobulin A nephropathy (IgAN), two types of primary proteinuric kidney diseases. The trial will enroll 100 patients equally among four treatment arms: 200mg ANG-3070 1x/day, 400mg ANG-3070 1x/day, 300mg ANG-3070 2x/day, and placebo with dosing for 12 weeks. The primary endpoint in the study is the percentage change in 24-hour urinary protein excretion at week 12.
“We are pleased to start dosing the first patients in this trial,” said John Neylan, M.D., Chief Medical Officer. “With positive Phase 1 study data reported earlier this year and demonstrated in vivo proof-of-concept for ANG-3070 in several animal models as an anti-fibrotic agent, this Phase 2 trial in patients with primary proteinuric kidney diseases is the next step to bring this potential treatment to patients with a variety of fibrotic diseases proven difficult to treat or for which there are limited treatment options.”
Angion also expects to file an IND at the end of 2022 for a global Phase 2 trial of ANG-3070 in patients with idiopathic pulmonary fibrosis. Additional details as to patient population, trial size, and trial endpoints will be announced later this year.
ANG-3070 was featured in a recent R&D Day conducted by Angion. A replay of this event is available in the events and presentations of the company’s website at www.angion.com.
Angion ended 2021 with approximately $88.8 million in cash and cash equivalents and expects these funds to be sufficient for operations well into 2023. The company will report complete financial results when it files its 10-K with the U.S. Securities and Exchange Commission in March of 2022.
Angion and its partner Vifor Pharma continue to analyze the full data sets from the ANG-3777 clinical trial readouts reported in the fourth quarter of 2021. Angion expects to communicate its future plans for ANG-3777 in the first quarter of 2022.
Angion’s management team will participate virtually in the H.C. Wainwright BioConnect Conference.
Details are as follows:
Event: H.C. Wainwright BioConnect Conference
Date: Monday, January 10th
Time: 7:00am Eastern US Time
The webcast of the presentation will be accessible online by visiting the events and presentations page under the investors section of Angion’s website at https://ir.angion.com/events-presentations. The webcast will remain archived on Angion’s website for approximately 30 days.
ANG-3070 is a highly selective oral tyrosine kinase receptor inhibitor in development as a treatment for fibrotic diseases, particularly in the kidney and lung. ANG-3070 has demonstrated activity as an anti-fibrotic agent in a variety of animal models. A Phase 1 healthy volunteer study demonstrated ANG-3070 to have a favorable safety and PK profile, producing plasma concentrations which exceeded those demonstrating activity in animal models of proteinuric kidney diseases. Enrollment is ongoing in a dose-finding Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases.
About Angion Biomedica Corp.
Angion is committed to transforming the treatment paradigm for patients suffering from fibrotic diseases and acute organ injuries for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate is ANG-3070, a highly-selective oral tyrosine kinase receptor inhibitor in development for the treatment of fibrotic kidney and lung diseases. Enrollment is ongoing in a dose-finding Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases. Angion’s ANG-3777 is a hepatocyte growth factor (HGF) mimetic. Angion and Vifor are evaluating next steps in this program based upon the full data set from the ANG-3777 Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI). 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 Statement
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 various fibrotic diseases’ future enrollment of the global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases; Angion’s expectations to file an IND at the end of 2022 and announce additional details on a global Phase 2 trial of ANG-3070 in patients with idiopathic pulmonary fibrosis later in 2022; and Angion’s expectations that its cash and cash equivalents to be sufficient for operations well into 2023. 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: analysis of trial results or continuing enrollment in clinical trials could be delayed for reasons outside of Angion’s control, including the effects of COVID-19 on Angion’s clinical programs and business operations; and unexpected costs may be incurred in connection with the clinical trial or other conduct of Angion’s business. For a description of additional risks and uncertainties, see Angion’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 12, 2021, particularly the information 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.
Director of Communications & Investor Relations