Avalo Therapeutics, Inc. (Nasdaq: AVTX) today announced that Mittie
Doyle, MD, FACR has joined the Company as its Chief Medical
Officer.
“We are thrilled to have Mittie join and grow
our leadership team at an exciting time as we prepare to initiate
our Phase 2 LOTUS Trial in patients with hidradenitis suppurativa.
Mittie brings to Avalo a strong combination of drug development
experience through all stages of development and exceptional
expertise in immunology, rheumatology and dermatology,” said Garry
A. Neil, MD, CEO and Chairman of the Board at Avalo. “Her
leadership guided by her robust experience will be invaluable to
the company as we progress AVTX-009 in hidradenitis suppurativa and
plan for the asset’s development in additional inflammatory
conditions.”
Dr. Doyle is a proven research physician who
brings over 20 years of experience in the pharmaceutical/biotech
industry and has held numerous leadership roles in clinical
development. Dr. Doyle joins Avalo from Aro Biotherapeutics where
she served as Chief Medical Officer since 2021. Dr. Doyle currently
serves on the Board of Directors of Santa Ana Bio, and she
previously served on the Board of Directors of DICE Therapeutics,
until it was acquired by Eli Lilly and Company. Prior to serving as
Chief Medical Officer of Aro Biotherapeutics, Dr. Doyle was Vice
President, Global Therapeutic Area Head, Immunology at CSL Behring.
Dr. Doyle has held senior level roles at Shire Pharmaceuticals,
Flexion Therapeutics and Alexion Pharmaceuticals. During her
career, she has advanced assets across a broad range of
immune-mediated and orphan diseases and led teams with
responsibilities for design and execution of first-in-human through
Phase 2 and 3 trials, resulting in several global regulatory
approvals. Dr. Doyle received her BA magna cum laude from Princeton
University in Romance Languages and her MD cum laude from Yale
Medical School. She completed her postdoctoral training at Harvard
Medical School including residency in Internal Medicine at
Massachusetts General Hospital and clinical/research fellowship in
Rheumatology and Immunology at Brigham and Women’s Hospital.
“I am honored to join the leadership team at
this important time for Avalo. Hidradenitis suppurativa is a
disease that can significantly impact quality of life and there is
a large unmet need for patients suffering from it. I believe
AVTX-009 has the potential to become a best-in-class and
best-in-disease treatment and I’m eager and focused on executing
the Phase 2 LOTUS Trial as an important next step to realize that
potential,” said Dr. Doyle. “AVTX-009 has broad potential to help
patients suffering from of a number of inflammatory conditions and
I am looking forward to initiating additional trials in new
indications with the ultimate goal to improve the quality of life
for these patients.”
Notice of Issuance of Inducement
GrantsIn connection with the appointment of Dr. Doyle and
in accordance with the terms of her employment agreement with
Avalo, Avalo’s Board of Directors approved the grant to Dr. Doyle
of a non-qualified stock option awarded to purchase 234,000 shares
of its common stock, vesting over four (4) years, with a
twelve-month cliff, such that the first 25% will vest on the first
anniversary following Dr. Doyle’s start date with Avalo, and the
remainder will vest in equal monthly installments over the
following three (3) years, in each case, subject to continued
employment with Avalo through the applicable vesting date. The
stock option was granted on Dr. Doyle’s start date of July 15, 2024
as an inducement material to Dr. Doyle becoming an employee of
Avalo in accordance with Nasdaq Listing Rule 5635(c)(4). The option
has an exercise price equal to the closing price of Avalo’s common
stock on The Nasdaq Capital Market on July 15, 2024. The option is
subject to the terms and conditions of the stock option agreement
covering the grant.
About Avalo TherapeuticsAvalo
Therapeutics is a clinical stage biotechnology company focused on
the treatment of immune dysregulation. Avalo’s lead asset is
AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. Avalo
also has two additional product candidates which include
quisovalimab (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion
protein). For more information about Avalo, please visit
www.avalotx.com.
About AVTX-009AVTX-009 is a
humanized monoclonal antibody (IgG4) that binds to interleukin-1β
(IL-1β) with high affinity and neutralizes its activity. IL-1β is a
central driver in the inflammatory process. Overproduction or
dysregulation of IL-1β is implicated in many autoimmune
and inflammatory diseases. IL-1β is a major, validated target for
therapeutic intervention. There is evidence that inhibition of
IL-1β could be effective in hidradenitis suppurativa and a variety
of inflammatory diseases in dermatology, gastroenterology, and
rheumatology.
About the LOTUS TrialThe LOTUS
Trial is a randomized, double-blind, placebo-controlled,
parallel-group Phase 2 trial with two AVTX-009 dose regimens
to evaluate the efficacy and safety of AVTX-009 in approximately
180 adults with moderate to severe hidradenitis suppurativa. The
primary efficacy endpoint is the proportion of subjects achieving
Hidradenitis Suppurativa Clinical Response (HiSCR75) at
Week 16. Subjects will be randomized (1:1:1) to receive either
one of two doses of AVTX-009 or placebo.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin
condition characterized by painful nodules, abscesses, and tunnels
that form in areas of the body such as the armpits, groin, and
buttocks, severely impacting the quality of life of affected
individuals.1 HS is often underdiagnosed or misdiagnosed and
therefore estimates of HS vary between 0.2-1.7% of the population
worldwide.2-5 The exact cause of HS is not fully understood but is
believed to involve a combination of genetic, hormonal, and
environmental factors. While advances in treatment have been made,
limited treatment options are available. IL-1β plays a crucial role
in the inflammatory cascade underlying HS, contributing to tissue
damage, inflammation, and disease progression. Given the
involvement of IL-1β in the inflammatory process of HS, we believe
therapies that target IL-1β offer a potential treatment option for
HS.
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: reliance on key personnel; drug development costs; timing
of trial results and other risks, including reliance on
investigators and enrollment of patients in clinical trials;
regulatory risks; integration of AVTX-009 into our operations;
general economic and market risks and uncertainties, including
those caused by the war in Ukraine and the Middle East; and those
other risks detailed in Avalo’s filings with the Securities and
Exchange Commission, available at www.sec.gov. 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.
References1Patel ZS et al. Curr
Pain Headache Rep. 2017;21(12):49.2Egeberg A, et al. JAMA Dermatol
2016;152:429–343Phan K, et al Biomed Dermatol 2020; 4: 2-64Jfri, A,
et al. JAMA Dermatol. 2021;157(8):924-315Nguyen TV, et al. J Eur
Acad Dermatol Venereol. 2021;35(1):50-61
For media and investor inquiries:Christopher
Sullivan, CFOAvalo Therapeutics, Inc.ir@avalotx.com410-803-6793
or
Chris BrinzeyICR
WestwickeChris.brinzey@westwicke.com339-970-2843
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