Athenex Announces European Commission Approval of Klisyri® (tirbanibulin) for the Topical Treatment of Actinic Keratosis
Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action that represents a significant step forward in the treatment of AK due to its short treatment protocol (one application daily for 5 days), proven efficacy, and safety profile.
“This approval by the
This approval is based on the positive results from two pivotal Phase III studies (KX01-AK-003 and KX01-AK-004), which were also published in the
AK is one of the most common diagnoses in dermatology practices and the reported prevalence in the European population is around 18%[2,3]. Treatment is a critical aspect in the management of the disease as it may progress to invasive skin squamous cell carcinoma.
In addition, Almirall has submitted Klisyri® for a marketing authorisation in
About Klisyri® (tirbanibulin)
Klisyri® (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) of the face or scalp. Two phase III studies (KX01-AK-003 and KX01-AK-004) evaluated the efficacy and safety of tirbanibulin ointment 1% (10 mg/g) in adults with AK on the face or scalp. The studies achieved their primary endpoint, which was defined as 100% clearance of the AK lesions at Day 57 within the face or scalp treatment areas, each study achieving statistical significance (p<0.0001) on this endpoint.
About Actinic Keratosis
Actinic keratosis (AK) or solar keratosis is a chronic and precancerous skin disease that occurs primarily in areas that have been exposed to ultraviolet radiation for a long period of time. It is usually found on the face, ears, lips, bald scalp, forearms, the posterior part of the hands, and lower legs. It is not possible to predict which AK lesions will develop into squamous cell carcinoma. AK is the most common pre-cancerous dermatological condition.
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 technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, 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. For more information, please visit www.athenex.com.
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,” “goal,” “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, uncertainties around regulatory reviews and approvals; our ability to agree with the FDA on a new clinical study for oral paclitaxel that is capital efficient; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities; 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.
- Blauvelt A, Kempers S, Lain E, et al. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
New England Journal of Medicine. 2021 Feb 11;384(6):512-520.
- Lucas R, McMichael T, Smith W,
Armstrong B. Solarultraviolet radiation: Global burden of disease from solar ultraviolet radiation: World Health Organization, 2006.
- Worldometer. Population of
Europe. 2020. Available at: https://www.worldometers.info/world-population/europe-population/ Accessed: October 2020. Skin Cancer Foundation. Actinic Keratosis Overview. Available at: https://www.skincancer.org/skin-cancer-information/actinic-keratosis/#:~:text=Actinic%20keratosis%20(AK)%20is%20the,to%20ultraviolet%20(UV)%20radiation January 2021.
Source: Athenex, Inc.