Aclaris Therapeutics Announces Positive Results from Phase 1 Multiple Ascending Dose Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor
18 9월 2023 - 8:00PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage
biopharmaceutical company focused on developing novel drug
candidates for immuno-inflammatory diseases, today announced
positive results from ATI-2138-PKPD-102, a Phase 1 Multiple
Ascending Dose (MAD) trial of the investigational compound
ATI-2138.
Preliminary data from the MAD trial demonstrated:
- that ATI-2138 was generally well tolerated at all doses tested
in the trial;
- that ATI-2138 had dose proportional pharmacokinetics (PK);
and
- a dose-dependent inhibition of both ITK and JAK3 exploratory
pharmacodynamic (PD) biomarkers, with near maximal inhibition
achieved at the 30 mg total daily dose.
Based on these results, Aclaris will progress this program into
a Phase 2a proof of concept study in patients with ulcerative
colitis, its previously announced intended first clinical
development target, and anticipates initiation of the trial in
early 2024. Aclaris is also exploring the potential of conducting a
second proof of concept trial in an additional T cell-mediated
autoimmune disease.
ATI-2138-PKPD-102 was a two-week Phase 1 MAD trial to
investigate the safety, tolerability, PK and PD of ATI-2138 in
healthy volunteers. The study enrolled 60 healthy subjects across 6
dosing cohorts ranging from 10 to 80 mg of total daily doses, with
8 active/2 placebo controlled per arm. No serious adverse events
were reported. The most common adverse events in subjects treated
with ATI-2138, and the only events occurring in more than 1
subject, were headache (assessed as mild, 2 subjects on 5 mg BID, 1
on 40 mg BID) and diarrhea (assessed as mild, 2 subjects on 5 mg
BID).
“The advancement of ATI-2138 to proof-of-concept stage of
development marks yet another example of the strength of our world
class discovery group and the KINect® platform,” stated Doug
Manion, M.D., Aclaris’ Chief Executive Officer. “It is a rarity for
a biotech company of our size to be armed with a productive
discovery engine and expertise that rivals larger pharmaceutical
companies.”
Continued Manion, “With so much unmet medical need remaining in
immuno-inflammatory diseases such as ulcerative colitis, it is
gratifying for all of us at Aclaris to progress the development of
ATI-2138 for patients who remain underserved by the existing
treatment options for the disease. Additionally, we look forward to
the data from our two most advanced programs – zunsemetinib
(ATI-450) in rheumatoid arthritis and ATI-1777 in atopic dermatitis
– expected later this year.”
Aclaris has made available a related presentation for the
ATI-2138 MAD trial data which can be found on the “Investors”
section of its website, www.aclaristx.com.
About ATI-2138
ATI-2138 is an investigational oral covalent ITK/JAK3 inhibitor
that is being developed as a potential therapeutic option across a
variety of T cell-mediated diseases. ITK is a T cell receptor
activated kinase involved in driving T cell effector functions
while JAK3 is a non-receptor tyrosine kinase responsible for the
signal transduction of common gamma receptor cytokines, IL-2, IL-4,
IL-7, IL-9, IL-15, and IL-21. In blocking both T cell receptor
function and cytokine signaling, ATI-2138 has potential utility in
T cell driven diseases. ATI-2138 is currently in clinical
development and its safety and efficacy has not been evaluated by
regulatory authorities.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing a pipeline of novel drug candidates to address
the needs of patients with immuno-inflammatory diseases who lack
satisfactory treatment options. The company has a multi-stage
portfolio of drug candidates powered by a robust R&D engine
exploring protein kinase regulation. For additional information,
please visit www.aclaristx.com.
Cautionary Note Regarding Forward-Looking
Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such as
“anticipate,” “believe,” “expect,” “intend,” “may,” “plan,”
“potential,” “will,” and similar expressions, and are based on
Aclaris’ current beliefs and expectations. These forward-looking
statements include Aclaris’ expectations regarding the timing of
the Phase 2a trial of ATI-2138 in ulcerative colitis as well the
potential future opportunities for the clinical development of
ATI-2138, and the timing of reporting results from other clinical
trials. These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements. Risks and uncertainties that may cause actual
results to differ materially include uncertainties inherent in the
conduct of clinical trials, Aclaris’ reliance on third parties over
which it may not always have full control, Aclaris’ ability to
enter into strategic partnerships on commercially reasonable terms
and other risks and uncertainties that are described in the Risk
Factors section of Aclaris’ Annual Report on Form 10-K for the year
ended December 31, 2022 and other filings Aclaris makes with the
U.S. Securities and Exchange Commission from time to time. These
documents are available under the “SEC Filings” page of the
“Investors” section of Aclaris’ website at www.aclaristx.com. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Aclaris as of the
date of this release, and Aclaris assumes no obligation to, and
does not intend to, update any forward-looking statements, whether
as a result of new information, future events or otherwise.
Aclaris Therapeutics Contact:
Robert A. Doody Jr.Vice President, Investor
Relations484-639-7235rdoody@aclaristx.com
Aclaris Therapeutics (NASDAQ:ACRS)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Aclaris Therapeutics (NASDAQ:ACRS)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024