Arcutis Provides Update on Phase 2a Clinical Trial Evaluating ARQ-252 Cream as a Potential Treatment for Vitiligo
July 01 2021 - 6:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), today announced
its decision to terminate the recently initiated Phase 2a clinical
trial evaluating ARQ-252, a topical small molecule inhibitor of
Janus kinase type 1 (JAK1), as a potential treatment for vitiligo
(ARQ-252-213). Arcutis’ decision is based on further analyses of
the ARQ-252 drug formulation used in both this vitiligo study and
the recently completed Phase 2b study evaluating ARQ-252 for the
treatment of chronic hand eczema (ARQ-252-205).
As previously announced, the Phase 2b chronic hand eczema study
did not meet its primary endpoint, with none of the ARQ-252 arms
achieving statistical significance versus vehicle. Further analyses
of that study pointed toward inadequate local drug delivery to the
skin as a key driver of the lack of efficacy.
“While we are disappointed to terminate this vitiligo study, we
believe topical JAK inhibition remains a promising strategy for the
treatment of both chronic hand eczema and vitiligo, and that
ARQ-252 has potential as a new treatment for both diseases.
Published clinical data for other topical JAK inhibitors have shown
encouraging results in both indications. Furthermore, the active
pharmaceutical ingredient in ARQ-252 -- SHR0302 -- is a potent and
highly selective JAK1 inhibitor that has demonstrated efficacy and
safety as an investigational oral formulation in other inflammatory
conditions such as rheumatoid arthritis and atopic dermatitis,”
said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of
Arcutis. “We have already made good progress in reformulating
ARQ-252 to potentially deliver much more active drug to targets in
the skin and hope to re-enter the clinic with this reformulated
version in the not-too-distant future. We want to thank the
patients and investigators in the vitiligo study for their
participation.”
The vitiligo study is not being terminated for any safety or
tolerability reasons. ARQ-252 has been safe and well-tolerated, and
no unexpected safety concerns have been identified.
About ARQ-252ARQ-252 is a small molecule
inhibitor of Janus kinase type 1 (JAK1). Many inflammatory
cytokines and other signaling molecules rely on the JAK pathway,
and specifically JAK1, which plays a central role in immune system
function. Inhibition of JAK1 has been shown to treat a range of
inflammatory diseases, including rheumatoid arthritis, Crohn’s
disease, and atopic dermatitis. The Company believes that due to
its high selectivity for JAK1 over JAK2, ARQ-252 has the potential
to effectively treat inflammatory diseases without causing the
hematopoietic adverse effects typically associated with JAK2
inhibition. In 2018, Arcutis exclusively licensed the active
pharmaceutical ingredient in ARQ-252 for all topical dermatological
uses in the United States, Europe, Japan and Canada from Jiangsu
Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed
a Phase 2b study in rheumatoid arthritis that used the same active
pharmaceutical ingredient as in ARQ-252 but dosed orally. The
results confirmed that this active pharmaceutical ingredient is a
highly potent inhibitor of JAK1 based on the drug’s impact on
rheumatoid arthritis, and was generally well tolerated at exposures
well above those expected with topical administration of ARQ-252 in
patients with chronic hand eczema. In 2020, Reistone Biopharma, a
subsidiary of Hengrui, announced positive topline results from a
Phase 2 clinical trial evaluating the oral version of the active
ingredient in ARQ-252 for the treatment of moderate-to-severe
atopic dermatitis. Reistone Biopharma is also studying the oral
formulation as a potential treatment for alopecia areata, Crohn’s
disease, and ulcerative colitis.About
ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a
medical dermatology company that champions meaningful innovation to
address the urgent needs of patients living with immune-mediated
dermatological diseases and conditions. With a commitment to
solving the most persistent patient challenges in dermatology,
Arcutis harnesses our unique dermatology development platform
coupled with our dermatology expertise to build differentiated
therapies against biologically validated targets. Arcutis’
dermatology development platform includes a robust pipeline with
seven clinical programs for a range of inflammatory dermatological
conditions, with our first NDA submission by the end of 2021 and
three more Phase 3 clinical data readouts anticipated over the next
18 months. The company’s lead product candidate, topical
roflumilast, has the potential to advance the standard of care for
plaque psoriasis, atopic dermatitis, scalp psoriasis, and
seborrheic dermatitis. For more information,
visit www.arcutis.com or follow Arcutis on LinkedIn and
Twitter.Forward-Looking StatementsThis press
release contains "forward-looking" statements, including, among
others, statements regarding the potential for Arcutis to conduct
clinical trials with a reformulated ARQ-252 and for the
reformulated product to treat chronic hand eczema and vitiligo.
These statements involve substantial known and unknown risks,
uncertainties and other factors that may cause our actual results,
levels of activity, performance, or achievements to be materially
different from the information expressed or implied by these
forward-looking statements and you should not place undue reliance
on our forward-looking statements. Risks and uncertainties that may
cause our actual results to differ include risks inherent in the
clinical development process and regulatory approval process, the
timing of regulatory filings, and our ability to defend our
intellectual property. For a further description of the risks and
uncertainties applicable to our business, see the "Risk Factors"
section of our Form 10-K filed with U.S. Securities and Exchange
Commission (SEC) on February 16, 2021, as well as any subsequent
filings with the SEC. We undertake no obligation to revise or
update information herein to reflect events or circumstances in the
future, even if new information becomes available.
Investor and Media Contact:ir@arcutis.com
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