Athenex and PharmaEssentia Announce Positive Early Signals of Clinical Activity of KX2-391 (INN: tirbanibulin) in Patients wi...
June 06 2019 - 7:00AM
Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical
company dedicated to the discovery, development and
commercialization of novel therapies for the treatment of cancer
and related conditions, and PharmaEssentia Corp. (Taipei
Exchange: 6446), a global biopharmaceutical company delivering
efficacious, safe and cost-effective therapeutic products for the
treatment of human diseases, today announced preliminary positive
clinical activity signals observed in a cohort of patients with
psoriasis treated with KX2-391 (INN: tirbanibulin) 1% ointment once
daily for 5 days in a Phase I clinical trial.
Six patients with mild to moderate psoriasis were studied. All
patients showed some improvement. One patient had complete
resolution of skin scaling and another patient had improvement of
psoriatic plaque thickness. The treatment was found to be
well-tolerated. Only mild (grade-1) skin burning sensation and
irritation were observed in one patient each.
Tirbanibulin (KX2-391) ointment has been well tolerated in
patients with psoriasis and also in trials treating patients with
actinic keratosis. Positive topline efficacy and safety results
from two Phase III studies of tirbanibulin ointment 1% in the
treatment of actinic keratosis were presented at the 2019 American
Academy of Dermatology Annual Meeting in a late breaker oral
presentation.
Dr. Johnson Lau, Chairman and Chief Executive Officer of
Athenex, commented, "We are delighted to observe positive early
clinical signals in this small cohort of patients. Based on the
results from our Phase II and III studies of this product in
actinic keratosis, we are confident about its safety profile for
psoriasis, which is treated according to a similar protocol. We are
working closely with our partner, PharmaEssentia, to further
evaluate the optimal treatment regimen for psoriasis using this
novel molecule."
Athenex licensed the rights to tirbanibulin (KX2-391) to
PharmaEssentia for psoriasis and non-malignant skin conditions
(excluding actinic keratosis) in Mainland China, Taiwan, Hong Kong,
Macau, Singapore and Malaysia, as well as the rights for actinic
keratosis in Taiwan. PharmaEssentia is sponsoring this Phase I
clinical trial in psoriasis. Athenex also licensed the rights to
tirbanibulin for any skin disorder or skin disease in humans,
including any skin cancer treated by dermatologists (but excluding
any other forms of cancer), in the U.S. and European countries,
including Russia, to Almirall, S.A.
The World Health Organization has recommended “tirbanibulin” as
the International Nonproprietary Name (INN) for KX2-391. The
Company may use the nomenclature “tirbanibulin” in future
communications.
Tirbanibulin: Novel Mechanism(s) of Action
Tirbanibulin (KX2-391) is a novel small molecule, discovered and
developed by Athenex. It has dual mechanisms of action consisting
of Src kinase inhibition (non-ATP competitive) and tubulin
polymerization inhibition resulting in upregulation of apoptosis in
proliferating cells, including anti-proliferative action in skin
cells.
About PsoriasisPsoriasis is a chronic
autoimmune skin disease that speeds up the growth cycle of skin
cells. Psoriasis causes localized or generalized patches of red
papules and plaques, covered with white or silver scales and
itching. According to the World Health Organization, psoriasis may
affect at least 100 million individuals worldwide.
About Athenex, Inc. Founded in
2003, Athenex, Inc. is a global clinical stage
biopharmaceutical company dedicated to becoming a leader in the
discovery, development and commercialization of next generation
drugs for the treatment of cancer. Athenex is organized
around three platforms, including an Oncology Innovation Platform,
a Commercial Platform and a Global Supply Chain Platform. The
Company’s current clinical pipeline is derived from four different
platform technologies: (1) Orascovery, based on non-absorbed
P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell
receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation
therapy. Athenex’s employees worldwide are dedicated to improving
the lives of cancer patients by creating more active and tolerable
treatments. Athenex has offices
in Buffalo and Clarence, New York; Cranford,
New Jersey; Houston, Texas; Chicago, Illinois; Hong
Kong; Taipei, Taiwan; and multiple locations
in Chongqing, China. For more information, please
visit www.athenex.com.
Forward-Looking Statements Except for
historical information, all of the statements, expectations, and
assumptions contained in this press release are forward-looking
statements. These forward-looking statements are typically
identified by terms such as “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “foresee,” “guidance,” “intend,”
“likely,” “may,” “plan,” “potential,” “predict,” “preliminary,”
“probable,” “project,” “promising,” “seek,” “should,” “will,”
“would,” and similar expressions. Actual results might differ
materially from those explicit or implicit in the forward-looking
statements. Important factors that could cause actual results to
differ materially include: the development stage of our primary
clinical candidates and related risks involved in drug development,
clinical trials, regulation, manufacturing and commercialization;
our reliance on third parties for success in certain areas of
Athenex’s business; our history of operating losses and need to
raise additional capital to continue as a going concern;
competition; intellectual property risks; risks relating to doing
business in China; and the other risk factors set forth from
time to time in our SEC filings, copies of which are
available for free in the Investor Relations section of our website
at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or
upon request from our Investor Relations Department. All
information provided in this release is as of the date hereof and
we assume no obligation and do not intend to update these
forward-looking statements, except as required by law.
CONTACTS
Investor Relations:
Tim McCarthy Managing Director, LifeSci Advisors, LLC Tel:
+1 716-427-2952 Direct: +1 212-915-2564
Athenex, Inc.:
Randoll Sze Chief Financial Officer
Email: randollsze@athenex.com
Jacqueline Li Corporate Development and Investor Relations
Email: jacquelineli@athenex.com
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