Angion Announces Discontinuation of Phase 2 Trial of ANG-3070 in Patients with Primary Proteinuric Kidney Disease
30 June 2022 - 06:05AM
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 AngionAngion 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.
Contact:
David D. Miller
Sr. Director of Corporate Affairs
investors@angion.com
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