Athenex Announces New England Journal of Medicine Publication of Phase III Data on the Efficacy and Safety of Klisyri® (tirbanibulin)

Rhea-AI Summary

The New England Journal of Medicine has published Phase III trial results for Klisyri®, a topical treatment for actinic keratosis (AK), developed by Athenex. Klisyri® shows a significant efficacy with 49% clearance of AK lesions compared to 9% with vehicle ointment at day 57. The trials, involving 702 patients, confirmed a favorable safety profile, with no serious adverse effects reported. Athenex's marketing partner, Almirall, is set to launch Klisyri® in the U.S. in February 2021. Approval from the FDA was granted in December 2020.

Positive

• 49% clearance of AK lesions with Klisyri® compared to 9% for vehicle at day 57.
• Favorable safety profile with no serious adverse events reported.
• FDA approval obtained in December 2020.
• Almirall to launch Klisyri® in the U.S. in February 2021.

Negative

• None.

• The New England Journal of Medicine published the Phase III trial results on Klisyri®, an anti-proliferative agent that inhibits tubulin polymerization and Src kinase signaling, for the topical treatment of actinic keratosis (AK) of the face or scalp
  
• Klisyri®, developed by Athenex, received FDA approval in December 2020
• Across two large Phase III randomized controlled clinical trials (pooled data) [1], a short convenient five-day course of Klisyri® ointment resulted in a significantly higher proportion of patients with complete clearance of AK lesions at day 57 in the treated areas (49%) than with vehicle ointment (9%)
• Klisyri® also has a favorable safety profile with mostly transient mild to moderate application-site reactions and no subject withdrew from the trials due to adverse reactions
• Almirall, our marketing partner, will launch Klisyri® in the U.S. in February 2021
  

BUFFALO, N.Y., Feb. 11, 2021 (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, announced today that the New England Journal of Medicine (NEJM) has published the results from the pivotal Phase III trials of Klisyri® ointment for actinic keratosis of the face or scalp in the February 11, 2021, issue.

“This important publication represents a significant achievement for Athenex and all of our colleagues who have worked to discover, develop, and bring Klisyri® to market,” said Dr. Johnson Lau, CEO of Athenex. “We would like to wholeheartedly thank our clinical investigators and the patients who participated in these trials, which were critical in confirming the clinical efficacy and safety profile in order to obtain FDA approval of Klisyri®.”

The Phase III trials evaluated the efficacy and safety of Klisyri® ointment 1% (10 mg/g) in adults with actinic keratosis on the face or scalp and included 702 patients across 62 sites in the United States. Enrollment of patients was controlled to achieve a 2:1 ratio of facial: scalp treatment areas. Patients were randomly assigned in a 1:1 ratio to receive Klisyri® ointment or vehicle ointment, which was self-administered to a contiguous treatment area of 25cm² on the face or scalp containing 4-8 typical AK lesions once daily for five consecutive days.

Dr. Volker Koscielny, MD, Chief Medical Officer of Almirall said “We are delighted by the publication of the Phase III data for Klisyri® in the NEJM, one of the most prestigious and rigorously peer-reviewed medical journals in the world. The clinical trial data presented not only demonstrates significant efficacy, but importantly a proven tolerability and safety profile. Added to the short 5-day application period, we believe that Klisyri® provides an important addition to the therapeutic armamentarium of US dermatologists in treating actinic keratosis.”

Both Phase III trials, KX01-AK-003 and KX01-AK-004, met the primary endpoint, which was defined as 100% clearance of AK lesions at Day 57 within the face or scalp treatment areas, each trial achieving a highly statistically significant result (p<0.0001). In KX01-AK-003, complete clearance was observed in 44% of the patients treated with Klisyri® versus 5% for those treated with vehicle, and in KX01-AK-004, complete clearance was observed in 54% of the patients treated with Klisyri® versus 13% for vehicle. Furthermore, tirbanibulin also achieved the secondary endpoint of partial (≥75%) clearance of lesions in each trial (68% of patients receiving Klisyri® versus 16% receiving vehicle in KX01-AK-003, and 76% versus 20% respectively in KX01-AK-004). Both results were again highly statistically significant (p<0.0001).

In both trials, patient-reported adverse events were mostly transient mild application-site pruritus and application-site pain. No patients experienced a serious adverse event or discontinuation due to Klisyri® or vehicle in either clinical trial. Signs of local skin reactions assessed by investigators were mostly mild to moderate erythema, flaking or scaling that peaked at day 8 (maximum mean composite local skin reaction score ≤4.3 out of 18 across both trials) and resolved spontaneously in about 2 weeks.

About Klisyri®

Klisyri® is a novel, topical first-in-class microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp. It represents a significant step forward in the treatment of AK due to its short treatment protocol (once daily application for five days) and proven efficacy and safety profile.

About Actinic Keratosis

Actinic keratosis or solar keratosis is a chronic and pre-cancerous 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 most common pre-cancerous dermatological condition. Actinic keratosis is the second most common diagnosis made by dermatologists in the United States[2].The reported prevalence of AK is between 11% and 25%[3].

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 

[1] Phase III studies KX01-AK-003 (NCT03285477) and KX01-AK-004 (NCT03285490)

[2] Wilmer, EN, Gustafson CJ, Ahn CS, Davis SA, Feldman SR, Huang WW. Most common dermatologic conditions encountered by dermatologists and non-dermatologists. Cutis. 2014 Dec;94(6):285-92

[3] Stockfeth, E., Fernandiz, C, Grob JJ, et al., Development of a treatment algorithm for actinic keratoses: a European Consensus. Eur J Dermatol. 2008;18(6):651-659

FAQ

What are the results of the Phase III trial for Klisyri® by Athenex?

The Phase III trial showed 49% clearance of actinic keratosis lesions at day 57 with Klisyri®.

When was Klisyri® approved by the FDA?

Klisyri® received FDA approval in December 2020.

What is the safety profile of Klisyri®?

Klisyri® has a favorable safety profile with mostly mild to moderate application-site reactions.

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

Klisyri® is set to launch in the U.S. in February 2021.

What percentage of patients achieved clearance in the Klisyri® trials?

49% of patients achieved complete clearance of AK lesions at day 57.