Avalo Therapeutics Announces First Patient Dosed in the Phase 2 PEAK Trial of AVTX-002 for the Treatment of Non-Eosinophilic Asthma (NEA)
18 May 2022 - 09:30PM
Avalo Therapeutics, Inc. (Nasdaq: AVTX), announced that the first
patient has been dosed in the company’s Phase 2 PEAK (A Phase 2,
Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
to Evaluate the Safety and Efficacy of AVTX-002 for
the Treatment of
Poorly Controlled
Non-
Eosinophilic
Asthma
K) trial evaluating AVTX-002 for the treatment of
non-eosinophilic asthma (NEA).
“Dosing the first patient in the Phase 2 PEAK trial brings us a
step closer to delivering a new treatment option to these patients.
Nearly half of all asthma patients have NEA, for which there is no
specific treatment currently approved,” said Garry A. Neil, MD,
President and Chief Executive Officer, Avalo Therapeutics.
Phase 2 TrialThe PEAK trial (n=approximately
80) is a 12-week randomized, double-blind, placebo-controlled study
to evaluate the safety and efficacy of AVTX-002 for the treatment
of poorly controlled NEA (NCT05288504). The primary endpoint is the
proportion of subjects who experience an asthma-related event. At
baseline, subjects will be randomized to receive either AVTX-002 or
placebo once monthly.
NEAAsthma is a chronic disease of the lungs
characterized by airway inflammation causing swelling and excess
mucous production. Asthma is classified as eosinophilic or
non-eosinophilic, with 50% of severe asthma cases related to NEA.
Many patients with NEA respond suboptimally to standard asthma
treatments, especially to inhaled corticosteroids. This can lead to
a higher severity of disease and more difficult-to-control asthma,
which can be life-threatening for some patients.
About Avalo Therapeutics Avalo Therapeutics is
a leading clinical-stage precision medicine company that discovers,
develops, and commercializes targeted therapeutics for patients
with significant unmet clinical need in immunology and rare genetic
diseases. The Company has built a diverse portfolio of innovative
therapies to deliver meaningful medical impact for patients in
urgent need. The Company’s clinical candidates commonly have a
proven mechanistic rationale, biomarkers and/or an established
proof-of-concept to expedite and increase the probability of
success.
For more information about Avalo, please visit
www.avalotx.com.
Forward-Looking Statements This press release
may include forward-looking statements made pursuant to the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts. Such
forward-looking statements are subject to significant risks and
uncertainties that are subject to change based on various factors
(many of which are beyond Avalo’s control), which could cause
actual results to differ from the forward-looking statements. Such
statements may include, without limitation, statements with respect
to Avalo’s plans, objectives, projections, expectations and
intentions and other statements identified by words such as
“projects,” “may,” “might,” “will,” “could,” “would,” “should,”
“continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,”
“anticipates,” “estimates,” “intends,” “plans,” “potential,” or
similar expressions (including their use in the negative), or by
discussions of future matters such as: the development of product
candidates or products; timing and success of trial results and
regulatory review; potential attributes and benefits of product
candidates; the future financial and operational outlook; and other
statements that are not historical. These statements are based upon
the current beliefs and expectations of Avalo’s management but are
subject to significant risks and uncertainties, including: Avalo's
cash position and the potential need for it to raise additional
capital; drug development costs, timing and other risks, including
reliance on investigators and enrollment of patients in clinical
trials, which might be slowed by the COVID-19 pandemic; reliance on
key personnel, including as a result of recent management changes;
regulatory risks; general economic and market risks and
uncertainties, including those caused by the COVID-19 pandemic and
tensions in Ukraine; and those other risks detailed in Avalo’s
filings with the SEC. Actual results may differ from those set
forth in the forward-looking statements. Except as required by
applicable law, Avalo expressly disclaims any obligations or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in Avalo’s expectations with respect thereto or any change in
events, conditions or circumstances on which any statement is
based.
For media and investor inquiriesChristopher
Sullivan, CFO Avalo Therapeutics,
Inc.ir@avalotx.com410-803-6793 or Chris Brinzey ICR Westwicke
Chris.brinzey@westwicke.com 339-970-2843
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