Athenex Announces Positive Topline Results from Two Phase III Studies of KX2-391 Ointment 1% Featured in Late Breaker Program at the 2019 American Academy of Dermatology Annual Meeting
Results show that 44% and 54% of patients in studies KX01-AK-003 and KX01-AK-004, respectively, achieved 100% AK lesion clearance at Day 57
Safety profile of KX2-391 ointment may be an important competitive advantage; adherence to treatment was greater than 99%
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Topline Efficacy Results
Both Phase III studies, KX01-AK-003 and KX01-AK-004, achieved their primary endpoint, which was defined as 100% clearance of the AK lesions at Day 57 within the face or scalp treatment areas (see Table 1).
Table 1: Efficacy Results of KX2-391 Ointment in the Field Treatment of Actinic Keratosis
|% of Subjects in the Intent-To-Treat Population
(Number of Subjects)
|100% AK Clearance on Day 57||44% (N=77)||5% (N=8)||<0.0001a||54% (N=97)||13% (N=22)||<0.0001a|
|≥75% AK Clearance on Day 57||68||%||16||%||<0.0001a||76||%||20||%||<0.0001a|
a = p-value calculated based on Cochran-Mantel-Haenszel (CMH)
Statistical significant difference in 100% clearance was demonstrated for all subgroups analyzed in both studies based on treatment location (face or scalp), gender, age (<65 and >65 years old), number of baseline AK lesions (4-6 versus 7-8 lesions) and also skin type. Compliance to 5-day of self-treatment was over 99% for both studies.
Safety results showed that KX2-391 ointment was well tolerated. Adverse events were few. Treatment related adverse events were mild to moderate application site symptoms, such as pruritus or pain. There were no serious adverse events or early discontinuations due to study drug related adverse events. Local skin reactions (LSR: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) were mostly mild to moderate.
These two double-blind, randomized, vehicle-controlled, parallel group, multi-center studies (KX-AK-003 and KX-AK-004) were designed to support the registration of KX2-391 ointment as field therapy for AK of the face or scalp. The studies enrolled a total of 702 patients across 62 sites in the US. KX2-391 ointment 1% or vehicle (randomized 1:1) was self-administered to 25 cm2 of the face or scalp encompassing 4-8 typical AK lesions, once daily for 5 consecutive days. Patients in both studies were predominantly white elderly male with fair skin type and median baseline AK lesions of 6 on the face or scalp.
The one year follow up of patients who had complete responses is ongoing and is expected to be complete in the second quarter 2019.
As announced on
KX2-391: Novel Mechanism of Action
KX2-391 is a novel small molecule, discovered and developed by
About Actinic Keratosis
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. AK is the most common pre-cancerous condition in dermatology and affects more than 55 million Americans, and account for between 14-29% of dermatologist visits in the U.S.1
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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. 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.
The company, founded almost 75 years ago with headquarters in
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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,” “probable,” “project,” “seek,” “should,” “will,” 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.
1. E. Stockfleth et al. Physician perceptions and experience of current treatment in actinic keratosis. JEADV 2015, 29, 298–306
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