Aclaris Therapeutics Provides R&D Update
January 11 2022 - 4:01PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage
biopharmaceutical company focused on developing novel drug
candidates for immuno-inflammatory diseases, today provides an
update on the status of certain of its clinical programs and on its
research and development (R&D) operations.
Clinical Program Update:
- Zunsemetinib, an Investigational Oral MK2
Inhibitor
- Aclaris initiated study activities and began activating sites
in December 2021 in the following two studies:
- ATI-450-RA-202: Phase 2b clinical trial of
zunsemetinib in subjects with moderate to severe rheumatoid
arthritis (RA). This is Aclaris’ second Phase 2 clinical trial of
zunsemetinib in subjects with moderate to severe RA, and is
primarily designed to assess the efficacy of multiple doses of
zunsemetinib to aid in the selection of an optimal dose to progress
in future development.
- ATI-450-HS-201: Phase 2a clinical trial of
zunsemetinib in subjects with moderate to severe hidradenitis
suppurative (HS).
- ATI-2138-PKPD-101: Aclaris completed dosing of
the first cohort of subjects in its Phase 1 single ascending dose
clinical trial of ATI-2138, its investigational oral ITK/TXK/JAK3
inhibitor, in healthy subjects, in December 2021. This is Aclaris’
first-in-human trial of ATI-2138, and is designed to assess the
safety and tolerability of ATI-2138 in healthy subjects and provide
dosing guidance for future clinical trials.
R&D Operations Update:
- David Gordon, Aclaris’ Chief Medical Officer, left the Company
effective January 7, 2022.
- Aclaris has bolstered its R&D group, including in the areas
of clinical, preclinical and discovery, quality, pharmacology, and
regulatory.
- As Aclaris continues to grow and evolve, the Company plans to
hire several key leadership positions over the coming months to
support the operational plans and strategic direction of the
Company.
“We are very excited to start the new year with the commencement
of three clinical trials,” said Dr. Neal Walker, President and CEO
of Aclaris. “Our clinical data to date demonstrate the potential
for zunsemetinib to be a new oral approach for the treatment of RA,
and we hope to further this finding in the Phase 2 trials,
including in additional indications, and support our hypothesis
that MK2 inhibition is an important novel target for the treatment
of immuno-inflammatory diseases. The commencement of our
first-in-human trial of ATI-2138 is also an important first step in
the clinical development of ATI-2138. In addition, as we expand and
develop our pipeline, we have and continue to strengthen the
breadth and expertise of our R&D group to meet our needs.
Lastly, we would like to thank Dave for his contributions to
Aclaris and we wish him the best in his future endeavors.”
About ATI-450-RA-202
ATI-450-RA-202 is a Phase 2b randomized, multicenter,
double-blind, parallel group, placebo-controlled, dose ranging
trial to investigate the efficacy, safety, tolerability,
pharmacokinetics and pharmacodynamics of multiple doses (20mg and
50mg BID) of zunsemetinib in combination with methotrexate in
subjects with moderate to severe RA. This trial will consist of a
12-week treatment period and a 30-day follow-up period, and will
seek to enroll subjects in the United States and in multiple
countries in Europe. The primary endpoint is the proportion of
subjects achieving American College of Rheumatology 20% (ACR20) at
week 12.
About ATI-450-HS-201
ATI-450-HS-201 is a Phase 2a randomized, multicenter,
double-blind, placebo-controlled trial to investigate the efficacy,
safety, tolerability, pharmacokinetics and pharmacodynamics of
zunsemetinib (50mg BID) in subjects with moderate to severe HS.
This trial will consist of a 12-week treatment period and a 30-day
follow-up period, and will seek to enroll subjects in the United
States. The primary endpoint is the change in inflammatory nodule
and abscess count at week 12.
About Zunsemetinib
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 tumor necrosis factor α (TNFα) and
interleukin-1α, -1β, -6 and -8 (IL1α, IL1β, IL6 and IL8). Aclaris
is developing zunsemetinib as a potential treatment for RA and
other immuno-inflammatory diseases.
About ATI-2138-PKPD-101
ATI-2138-PKPD-101 is a first-in-human Phase 1 randomized,
observer-blind, placebo-controlled, single ascending dose trial to
investigate the safety, tolerability, pharmacokinetics and
pharmacodynamics of ATI-2138 in healthy subjects.
About ATI-2138
ATI-2138 is an investigational oral ITK/TXK/JAK3 (ITJ)
inhibitor. The ITJ compound interrupts T cell signaling through the
combined inhibition of ITK/TXK/JAK3 pathways in lymphocytes.
Aclaris is developing ATI-2138 as a potential treatment for T-cell
mediated autoimmune diseases.
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 the
clinical development and potential benefits of zunsemetinib as
a potential treatment for HS and RA and ATI-2138 as a
potential treatment for psoriasis and/or inflammatory bowel
disease, and the planned expansion of additional personnel. 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, the
uncertainty regarding the COVID-19 pandemic 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,
2020 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 Contact
investors@aclaristx.com
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