Angion Provides Corporate Update and Announces Participation in Upcoming Investor Conference
05 January 2022 - 08:05AM
Angion Biomedica Corp (NASDAQ:ANGN), a biopharmaceutical company
focused on the discovery, development, and commercialization of
novel small molecule therapeutics to address fibrotic diseases 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 UpdateAngion’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.
Corporate UpdateAngion 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.
Investor EventAngion’s management team will
participate virtually in the H.C. Wainwright BioConnect
Conference.
Details are as follows:Event: H.C. Wainwright BioConnect
ConferenceDate: 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.
About ANG-3070ANG-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 StatementStatements 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.
ContactDavid MillerDirector of Communications
& Investor Relationsinvestors@angion.com
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