Avalo Reports Positive Phase 1b Results for AVTX-002 in Moderate to Severe Crohn's Disease Patients and Presents Additional Program Updates at 2022 Investor Event
06 January 2022 - 11:30PM
Avalo Therapeutics, Inc. (Nasdaq: AVTX), 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, today
provides a comprehensive update on the Company’s growth
opportunities and mid-stage development portfolio.
“Avalo is poised for a pivotal year in 2022,”
said Mike Cola, Chief Executive Officer of Avalo Therapeutics.
"With multiple product candidates in clinical development, our
focus is now on advancing and unlocking the value of these
innovative therapies. We are particularly encouraged by our second
positive trial with AVTX-002 and are excited by the broad potential
in inflammatory diseases. As we progress our therapies towards
pivotal trials and potential approvals, we believe there will be a
number of business development opportunities creating optionality
for the Company.”
Program Updates and Key
Highlights
AVTX-002 Phase 1b Crohn’s Disease (CD)
Clinical Trial Results:
- The Phase 1b, open-label,
dose-escalation, signal-finding, multi-center study evaluated the
safety, tolerability, pharmacokinetics, and short-term efficacy of
AVTX-002 in adults with moderate to severe, active CD who have
previously failed anti-tumor necrosis factor alpha (anti-TNFα)
treatment. The study evaluated two different doses of AVTX-002 (1.0
mg/kg and 3.0 mg/kg) in which all subjects received a total of four
doses of AVTX-002 by subcutaneous (SQ) injection at 14-day
intervals and underwent colonoscopies at baseline and again at
eight weeks.
- Clinically meaningful mucosal
healing, determined by colonoscopy and adjudicated by a central
reader, was observed in fifty percent (4/8) of subjects with one
subject achieving remission (SES-CD = 0). Additionally, patients
responded rapidly to treatment within eight weeks and free LIGHT
levels decreased in all subjects.
- Seventy-five percent (3/4) of
patients that demonstrated mucosal healing by colonoscopy reported
they had returned to doing poorly two to three months after
cessation of study drug, suggesting a drug-related effect;
follow-up is ongoing for the remaining responder. Data continued to
show that treatment with AVTX-002 was safe and well tolerated with
no drug-related serious adverse events observed.
- Avalo continues to evaluate the
biomarker data from this study.
- The Company is currently evaluating
AVTX-002 in a cohort of ulcerative colitis (UC) patients with
moderate to severe UC who are refractory to biologic therapy,
including anti-TNFα, with data anticipated in the third quarter of
2022. Data from the CD and UC studies will inform the design for a
subsequent randomized controlled clinical study in moderate to
severe refractory patients.
AVTX-002 for the treatment of
non-eosinophilic asthma (NEA):
- NEA is a significant subtype of
asthma with a poor prognosis that encompasses approximately half of
asthma patients. Biomarker data suggests that LIGHT plays a strong
role in inflammation and airway remodeling in NEA and support the
development of AVTX-002 for poorly controlled NEA patients.
- An investigational new drug (IND)
application has been cleared by the FDA. The Company expects
top-line data from the randomized, double-blind, placebo-controlled
Phase 2 clinical trial in 80 patients with poorly-controlled NEA in
the second half of 2022.
AVTX-007 in Multiple Myeloma and Adult
Onset Still’s Disease (AOSD):
- Multiple Myeloma: The multicenter,
open-label, dose-escalation Phase 1b study of AVTX-007 (anti-IL-18
mAb) in subjects with relapsed and refractory multiple myeloma is
nearing completion. Three doses (4 mg/kg, 9 mg/kg and 14 mg/kg
every 4 weeks) of AVTX-007 as a single agent were evaluated.
AVTX-007 was generally safe and well tolerated, but no efficacy
signal was seen in the high dose cohort or expansion phase. Based
on these results, the Company is discontinuing the multiple myeloma
program.
- AOSD: AVTX-007 is being evaluated
in a multicenter, Phase 1b study in 12 refractory or
steroid-dependent patients with AOSD in two cohorts. Top-line data
for both cohorts of the trial are anticipated by mid-year
2022.
AVTX-800 programs (AVTX-801, AVTX-802,
and AVTX-803) for Congenital Disorders of
Glycosylation:
- Avalo plans to initiate the
single-center (US), double-blind (plus open-label extension)
pivotal study of AVTX-803 in patients with leukocyte adhesion
deficiency type II (LAD II) caused by loss-of-function mutation in
the SLC35C1 gene in the first quarter of 2022, with data
expected in the third quarter of 2022.
- The Company remains in dialogue
with the FDA to align on suitable clinical study designs for
AVTX-801 (loss-of-function mutation in the PGM1 gene) and
AVTX-802 (loss-of-function mutation in
the MPI gene).
- All three of these programs have
received Orphan Drug Designation (ODD) and Rare Pediatric Disease
Designation (RPDD) which make them eligible for Priority Review
Vouchers upon approval.
AVTX-006 in Complex Lymphatic
Malformations:
- The Company expects top-line data
from its Phase 1b proof-of-concept of AVTX-006 (dual mTORc1/c2
small molecule inhibitor) for complex lymphatic malformations in
mid-year 2022.
- AVTX-006 has received ODD and RPDD
making it eligible for Priority Review Voucher upon approval.
Virtual Investor DayThe Company
will host a virtual investor day today on January 6th starting at
8:00 a.m. ET that will include presentations from members of
Avalo’s senior management team. The event will provide a
comprehensive update on Avalo’s lead programs and clinical-stage
pipeline.
A live webcast of the event, as well as a
replay, will be available on the Investors section of Avalo’s
website at www.avalotx.com or linked here.
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,
immuno-oncology, 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 StatementsThis
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 future financial and
operational outlook; the development of product candidates or
products; timing and success of trial results and regulatory
review; potential attributes and benefits of product candidates;
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: 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;
regulatory risks; Avalo's cash position and the potential need for
it to raise additional capital; general economic and market risks
and uncertainties, including those caused by the COVID-19 pandemic;
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
inquiries
Chris BrinzeyWestwicke, an ICR
CompanyChris.brinzey@westwicke.com339-970-2843
or
Schond L. GreenwayInvestor RelationsChief
Financial OfficerAvalo
Therapeuticssgreenway@avalotx.com610-522-6200
For media inquiries
Robert Stanislaro or Helen O’GormanFTI
Consultingrobert.stanislaro@fticonsulting.comhelen.o’gorman@fticonsulting.com
Avalo Therapeutics (NASDAQ:AVTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Avalo Therapeutics (NASDAQ:AVTX)
Historical Stock Chart
From Apr 2023 to Apr 2024