Athenex Announces FDA Approval of Klisyri® (Tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

Rhea-AI Summary

Athenex, Inc. (NASDAQ: ATNX) announced FDA approval for Klisyri® (tirbanibulin), the first proprietary product for the treatment of actinic keratosis on the face or scalp. Developed internally, this first-in-class microtubule inhibitor requires a 5-day application course and will be launched in partnership with Almirall in Q1 2021. The approval is based on positive Phase III trial results showing significant lesion clearance. Athenex is positioned to leverage its manufacturing capabilities and vertical integration for market success.

Positive

• FDA approval of Klisyri® represents the first proprietary product for Athenex.
• Klisyri® is a first-in-class microtubule inhibitor with a 5-day treatment schedule.
• Successful Phase III studies showed significant efficacy in clearing actinic keratosis lesions.

Negative

• Potential risks of local skin reactions and application site adverse effects noted.

• Klisyri^® is the first FDA approved proprietary product for Athenex
  
• First-in-class microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) on the face or scalp with a 5-day application course
• Klisyri will be manufactured by Athenex
• Almirall will launch Klisyri in the U.S. in first quarter 2021

BUFFALO, N.Y., Dec. 15, 2020 (GLOBE NEWSWIRE) -- 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, today announced that the U.S. Food and Drug Administration (FDA) has approved Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. Klisyri is the first FDA approved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. during the first quarter of 2021. Klisyri will be manufactured by Athenex, highlighting the vertically integrated capabilities of the company ranging from a preclinical lead to a developed product for market launch.

“The FDA approval of Klisyri is a significant milestone for Athenex. Klisyri is a home-grown product discovered and characterized by Athenex scientists and developed from pre-IND to NDA by the Athenex team. We are extremely proud of our team’s excellent execution,” said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. “Approval demonstrates our ability to execute upon the entirety of the drug development and registration process. We are excited to partner with Almirall to bring this first-in-class microtubule inhibitor to patients with actinic keratosis in the US.”

Dr. Rudolf Kwan, Chief Medical Officer of Athenex added, “The FDA approval of tirbanibulin ointment represents a first-in-class microtubule inhibitor for the treatment of actinic keratosis. We believe this small molecule platform has the potential beyond actinic keratosis and are leveraging the platform to develop therapies for other oncology indications.”

Mr. Peter Guenter, CEO of Almirall, stated, “We are delighted to partner with Athenex to market Klisyri in the U.S. and in Europe. This approval from the FDA represents a new option for Dermatologists and marks an important further step for Actinic Keratosis patients. What makes this new therapy particularly exciting is the 5-day course of treatment and its good tolerability. We look forward to the launch of Klisyri in the US in the first quarter of 2021.”

The FDA approved Klisyri based on the data from two pivotal, randomized, double-blind, vehicle-controlled Phase III studies (KX01-AK-003 and KX01-AK-004) that evaluated the efficacy and safety of Klisyri (tirbanibulin) ointment 1% in 702 adults with actinic keratosis of the face or scalp. Tirbanibulin demonstrated complete clearance of actinic keratosis lesions at day 57 in treated face or scalp areas in a significantly higher number of patients compared to vehicle. The most common adverse events were application site pruritus and pain reported by 9% and 10% of treated patients, respectively.

Actinic keratosis is a pre-cancerous skin lesion and is the second most common diagnosis made by dermatologists in the United States. If left untreated, 10-15% of AK lesions will develop into skin cancers.

Athenex has partnered with Almirall (Almirall, S.A., BME: ALM) to market Klisyri for the treatment of actinic keratosis on the face or scalp in the US and EU (including Russia) markets. In addition to the partnership with Almirall, Athenex has partnered with PharmaEssentia (6446.TWO) for actinic keratosis in Taiwan and has partnered with Xiangxue Pharmaceuticals (SHE:300147) for actinic keratosis in China, Hong Kong, and Macau.

About Klisyri^®
Klisyri® (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis on the face or scalp. The two double-blind, vehicle-controlled, randomized, parallel group, multicenter, 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 actinic keratosis on the face or scalp.

The studies enrolled a total of 702 patients across 62 sites in the U.S. Tirbanibulin ointment 1% (10 mg/g) 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.

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, each study achieving statistical significance (p<0.0001) on this endpoint. In the KX01-AK-003 study, complete clearance was observed in 44% of the patients treated with tirbanibulin versus 5% for the vehicle treated groups. In the KX01-AK-004 study, complete clearance was observed in 54% of the patients treated with tirbanibulin and 13% for vehicle treated groups.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Ophthalmic Adverse Reactions
KLISYRI may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible.

Local Skin Reactions
Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration) in the treated area can occur after topical application of KLISYRI. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of KLISYRI is more likely to result in irritation.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain.

About Actinic Keratosis
Actinic keratosis or solar keratosis is a chronic and precancerous skin disease that occurs primarily in areas that have been exposed to ultraviolet (UV) 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, so all lesions should be treated by a dermatologist. Actinic keratosis is the second most common diagnosis made by dermatologists in the United States.

About Almirall
Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and groundbreaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX 35 (ticker: ALM). Throughout its 77-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2019 were 908.4 million euros. For more information, please visit almirall.com.

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 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; multiple locations in Chongqing, China; Manchester, UK; Guatemala City, Guatemala and Buenos Aires, Argentina. 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,” “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, 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; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; competition; intellectual property risks; risks relating to doing business internationally and in China; the risk of production slowdowns or stoppages or other interruptions at our Chongqing 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.

CONTACTS

Investors

Steve Rubis
Athenex, Inc.
Email: stevenrubis@athenex.com 

Daniel Lang, MD
Athenex, Inc.
Email: danlang@athenex.com 

Tim McCarthy
LifeSci Advisors, LLC
Email: tim@lifesciadvisors.com

Media

Gloria Gasaatura
LifeSci Communications, LLC
Email: ggasaatura@lifescicomms.com

FAQ

What is Klisyri® (tirbanibulin) used for?

Klisyri® is indicated for the topical treatment of actinic keratosis on the face or scalp.

When will Klisyri® be launched in the U.S.?

Klisyri® is set to launch in the U.S. in the first quarter of 2021.

What were the Phase III study results for Klisyri®?

Phase III studies demonstrated significant lesion clearance at day 57, with 44% and 54% of patients achieving complete clearance.

What are the common adverse effects of Klisyri®?

Common adverse effects include application site pruritus and pain, reported by 9% and 10% of patients, respectively.

What is the significance of Klisyri®'s FDA approval for Athenex?

The approval marks a major milestone as Klisyri® is the first FDA-approved proprietary product for Athenex.