Athenex (Nasdaq:ATNX), a global biopharmaceutical company dedicated
to the discovery, development and commercialization of novel
therapies for the treatment of cancer and related conditions, today
announced that the Phase II clinical study data for KX2-391 for the
treatment of actinic keratosis was presented by Dr. Seth Forman of
Forward Clinical Trials, Tampa, at the American Academy of
Dermatology Annual Meeting on February 17, 2018 in San Diego,
California (abstract ID 6134).
Actinic keratosis is a common skin condition that is induced
through ultra-violet light damage, resulting in patches of thick,
scaly or crusty skin. Left untreated, the lesions have risk of
progression to squamous cell carcinoma and consequently treatment
by a dermatologist is recommended. Actinic keratosis is the most
common pre-cancerous condition in dermatology and affects more than
55 million Americans. Actinic keratosis constitutes between 14-29%
of dermatologist visits in the USA1.
KX2-391, also known as KX-01, is a first-in-class dual Src
kinase and tubulin polymerization inhibitor being developed as a
topical medicinal product for the treatment of actinic
keratosis.
This Phase II clinical study aims to determine the activity,
safety and pharmacokinetics of KX2-391 ointment 1% (5 days or 3
days) in adults with actinic keratosis on the face or scalp. This
is an open-label, multicenter study conducted in adults who had 4-8
actinic keratosis lesions within a 25 cm2 area on the face or
scalp. A cohort of subjects was given once daily application for 5
days and was assessed through Day 57 for actinic keratosis lesion
counts, local skin reactions (LSRs), and adverse events (AEs). LSRs
were scored on a scale of 0 to 4 (worst). A second cohort of 3-day
treatment was enrolled after the 5-day treatment regimen
demonstrated activity and safety.
A total of 168 patients were recruited (84 for each cohort) from
16 US clinical sites. Subjects were mostly white males, with a mean
age of 68 years, skin type I to III and median baseline number of
actinic keratosis lesions of 6 for the 5-day treatment cohort and 5
for the 3-day treatment cohort. The 5-day treatment cohort achieved
a higher overall 100 percent clearance of actinic keratosis lesions
at Day-57 (i.e. 8 weeks after the initiation of treatment) than the
3-day treatment cohort (43% vs. 32%). In the 5-day treatment
cohort, 23 of 44 subjects (52%) with actinic keratosis on face and
13 of 40 (33%) on scalp attained 100 percent clearance at Day-57.
LSRs were mild and mostly erythema, flaking/scaling, crusting and
swelling with the majority of the LSRs scores of <2 and resolved
rapidly. Only one subject scored 4 in erythema and flaking/scaling,
which both resolved rapidly without concomitant medications.
Erosions/ulcers and vesicles/pustules were observed in only 15% and
5% of subjects, respectively. No subjects scored ≥3 in
erosions/ulcers/vesicles/pustules. Treatment related AEs were few
and predominately mild transient application site pruritus,
tenderness and pain. There were no treatment related serious AEs or
discontinuations. Plasma levels of KX2-391 were low to
undetectable.
Dr. Seth Forman, the presenting investigator for the Phase II
study, commented, “This study demonstrated that KX2-391 ointment 1%
is well tolerated and active as a field treatment of actinic
keratosis of the face and the scalp with LSRs that are mostly mild
and transient. KX2-391 ointment 1% daily for 5 consecutive days is
currently being investigated in two Phase III placebo-controlled
trials.”
Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, “We
are excited to see the excellent efficacy and safety profile of
KX2-391 ointment 1% for the treatment of actinic keratosis. KX01
treatment may have the potential to change the paradigm of topical
therapy for actinic keratosis.”
Athenex and the FDA previously had an end of Phase II meeting
regarding the program for the design of the Phase III studies. Two
placebo-controlled Phase III studies, with a total target of 600
patients (300 patients for each study) were initiated on September
25, 2017 and the enrollment was completed rapidly ahead of an
aggressive schedule. Athenex expects topline data of the Phase III
studies to be available in the third quarter of 2018.
As previously announced on December 11, 2017, Athenex and
Almirall, a leading skin-health focused global pharmaceutical
company and one of the leaders in the field of actinic keratosis
treatment, entered into a license agreement in which Athenex
granted Almirall an exclusive license under the Athenex
Intellectual Property to research, develop and commercialize
KX2-391 in the United States of America and European countries,
including Russia. Athenex will receive an upfront fee and near-term
payments of up to USD $55 million, and additional indications
milestones payment and a royalty payment starting at 15% based on
annual net sales, with incremental increases in royalty rates with
increased sales. Athenex retains certain co-promotion rights in the
USA and retains the rights for other parts of the world including
Canada, Central and South America, Japan, Asia and China, Australia
and New Zealand, and Africa including South Africa. Almirall will
employ its expertise to support the development in Europe and also
to commercialize the product in the defined territories. Milestones
were established to encourage the joint effort of Athenex and
Almirall to develop additional indications and additional
formulations.
Mr. Peter Guenter, Chief Executive Officer of Almirall, stated,
“As one of the leaders of the medical treatment of actinic
keratosis, we were excited by the potential profile of KX2-391, as
demonstrated in this Phase II clinical study. We are also impressed
by the Athenex team’s capabilities in drug development execution.
We are pleased that the Athenex team has already completed the
enrollment of the two Phase III studies of 600 patients in the USA.
We are fully committed to this collaboration and will assist in the
European development and registration strategy. We believe that
KX2-391 has the potential to change the standard of care for
actinic keratosis and look forward to combining our leadership
abilities in the field with the drug development expertise of
Athenex.”
References
- E. Stockfleth et al. Physician perceptions and
experience of current treatment in actinic keratosis. JEADV 2015,
29, 298–306
About Athenex, Inc.Founded in
2003, Athenex, Inc. is a global clinical stage
biopharmaceutical company dedicated to becoming a leader in the
discovery and development 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. Athenex’s Oncology
Innovation Platform generates clinical candidates through an
extensive understanding of kinases, including novel binding sites
and human absorption biology, as well as through the application of
Athenex’s proprietary research and selection processes in the lab.
The Company’s current clinical pipeline is derived from two
different platform technologies Athenex calls Orascovery
and Src Kinase Inhibition. The Orascovery platform is based on the
novel oral P-glycoprotein pump inhibitor molecule HM30181A, through
which Athenex is able to facilitate oral absorption of
traditional cytotoxics, which Athenex believes may offer
improved patient tolerability and efficacy as compared to IV
administration of the same cytotoxics. The Orascovery platform was
developed by Hanmi Pharmaceuticals and licensed
exclusively to Athenex for all major worldwide
territories except Korea, which is retained by Hanmi. The Src
Kinase Inhibition platform refers to novel small molecule compounds
that have multiple mechanisms of action, including the inhibition
of the activity of Src Kinase and the inhibition of tubulin
polymerization during cell division. Athenex believes the
combination of these mechanisms of action provides a broader range
of anti-cancer activity as compared to either mechanism of action
alone. 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.
Forward-Looking Statement Disclaimer/Safe Harbor
StatementExcept for historical information, all of the
statements, expectations, and assumptions contained in this press
release are forward-looking statements. 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, including Almirall for
success in certain areas of Athenex’s business; need to raise
additional capital; 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. We assume no
obligation and do not intend to update these forward-looking
statements, except as required by law.
CONTACT:Jim PolsonTel: +1-716-427-2952Athenex, Inc.
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