Aclaris Therapeutics Completes Enrollment in Phase 2b Study of Oral Zunsemetinib (ATI-450) for Moderate to Severe Rheumatoid Arthritis (ATI-450-RA-202)
June 13 2023 - 7:01AM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage
biopharmaceutical company focused on developing novel drug
candidates for immuno-inflammatory diseases, today announced the
completion of enrollment into ATI-450-RA-202, its Phase 2b trial of
oral zunsemetinib in patients with moderate to severe rheumatoid
arthritis (RA). Aclaris expects to announce top-line efficacy,
safety and other preliminary data from this trial in the fourth
quarter of this year.
“We are very pleased with the rate of enrollment into this
important trial in the development of zunsemetinib for RA,
reflecting the commitment and enthusiasm of our investigators,
their patients, our partners and our own team,” stated Gail
Cawkwell, M.D., Ph.D., Aclaris’ Chief Medical Officer. “I am
particularly encouraged by the low rate of discontinuations in this
trial to date, as well as the fact that our data safety monitoring
committee, which meets regularly, has not raised any concerns
through this point in the trial. We look forward to reporting the
top line results in the fourth quarter.”
ATI-450-RA-202 is a Phase 2b, randomized, multicenter,
double-blind, placebo-controlled, dose-ranging study to investigate
the efficacy, safety, tolerability, pharmacokinetics and
pharmacodynamics of two doses of zunsemetinib plus methotrexate
(MTX) versus placebo plus MTX in patients with moderate to severe
RA who have had an inadequate response to MTX alone. The study has
enrolled 251 patients across the three treatment arms (ATI-450 20mg
BID, ATI-450 50mg BID, Placebo) at over 20 trial sites in the U.S.,
Poland, Bulgaria and Czech Republic. The primary efficacy endpoint
is the proportion of patients achieving an ACR20 response following
12 weeks of treatment. Secondary efficacy endpoints include ACR50
response, ACR70 response, DAS28-CRP and other pertinent RA
measures.
About Zunsemetinib
(ATI-450)
Zunsemetinib is an investigational oral mitogen-activated
protein kinase-activated protein kinase 2 (MK2) inhibitor. This
mechanism potentially leads to the inhibition of multiple
cytokines, chemokines, matrix metalloproteases and other
inflammatory signals. Key inflammatory cytokines driven by this
mechanism include TNFα and interleukin-1α, -1β, -6, -8 and -17
(IL1α, IL1β, IL6, IL8 and IL17). Aclaris is developing zunsemetinib
as a potential treatment for rheumatoid arthritis and psoriatic
arthritis, with potential future opportunities in a variety of
other immuno-inflammatory conditions.
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
“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 reporting results from
ATI-450-RA-202 as well the potential future opportunities for the
clinical development of zunsemetinib. 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
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