On February 14, 2018 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, reported early completion of patient enrollment for both Phase III clinical studies of KX2-391 Ointment for actinic keratosis indications months ahead of schedule (Press release, Athenex, FEB 14, 2018, View Source;p=RssLanding&cat=news&id=2332390 [SID1234523964]).

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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 it affects more than 55 million Americans. Actinic keratosis constitutes between 14-29% of dermatologist visits in the USA.1

KX2-391, also known as KX-01, is a dual Src kinase and tubulin polymerization inhibitor and a first-in-class topical treatment of actinic keratosis. Phase I and Phase II clinical studies showed excellent efficacy and safety results. After the FDA end of Phase II meeting, two randomized double-blind controlled Phase III trials totaling 600 patients were initiated in September 2017 in the United States and completed patient recruitment in February 2018.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "KX2-391 ointment, given its excellent clinical efficacy and safety profile compared to existing medical therapy, has the potential to change the paradigm of topical therapy for actinic keratosis. We are delighted to see that our investigators and patients are also seeing the potential of this new treatment as indicated by the rapid completion of patient enrollment in around four months which is extremely fast, and three months ahead of our original schedule. Such rapid patient recruitment rates in clinical trials underscores the excitement of the clinical and scientific communities."

Dr. Johnson Lau, Athenex’s Chief Executive Officer and Chairman of the Board, stated, "This excellent milestone highlights the quality of our clinical team members and operation. Our previous commitment to build an internal clinical operation will also ensure that the clinical trial monitoring and management, database management, and biostatistics will not be dependent on outside vendors. As such, we are confident that all aspects of treatment, follow up, monitoring, and database will be completed on time. We are now expecting topline data to be available in third quarter of 2018. We also look forward to presenting our Phase II data to the public in the upcoming American Academy of Dermatology meeting on February 17, 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.

Peter Guenter, Chief Executive Officer at Almirall, said, "We are impressed by the Athenex team in their execution of drug development. KX2-391, given its efficacy and very good safety profile compared to existing medical therapies, has the potential to change the standard of care for actinic keratosis, as well as expand the market since many patients remain undiagnosed or untreated. Almirall’s experience in Europe, currently as leaders in actinic keratosis, and our presence in the United States will help to develop and commercialize this product. We are now expecting top line Phase III data to be available in the third quarter of 2018. We also look forward to the presentation of the Phase II data to the public in the upcoming American Academy of Dermatology meeting on February 17, 2018."

References
1. E. Stockfleth et al. Physician perceptions and experience of current treatment in actinic keratosis. JEADV 2015, 29, 298–306