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Athenex Announces Positive Phase 3 Endpoints

Both studies, KX-AK-003 and KX-AK-004, had achieved their primary endpoint of 100% clearance of actinic keratosis lesions

Athenex announced that both Phase 3 studies, KX-AK-003 and KX-AK-004, had achieved their primary endpoint of 100% clearance of actinic keratosis (AK) lesions at Day 57 within the face or scalp treatment areas, with each study achieving statistical significance (p<0.0001).  Statistical significance (p<0.001) was achieved for both face and scalp subgroups as well.


These two double-blind, randomized, vehicle-controlled, studies were designed as pivotal Phase 3 efficacy and safety studies to support the registration of KX2-391 (or KX-01) as field therapy for AK of the face and scalp.  The studies, each conducted at 31 centers in the USA, enrolled a total of 702 subjects.  

These two parallel Phase 3 pivotal studies were initiated in September 2017. In February 2018, Athenex announced that the recruitment had been completed ahead of schedule. Both studies are still on-going to complete the one-year follow-up of the patients who had complete responses. Athenex will be submitting a request to the US FDA for a pre-NDA submission meeting to discuss the data and regulatory submission timelines. 
 
Dr. Rudolf Kwan, Athenex’s chief medical officer, said, “These two pivotal studies confirmed that KX2-391 ointment 1% is well tolerated and active as a field treatment of actinic keratosis of the face and the scalp, with LSRs that are mostly mild and transient. The rapid recruitment of patients into the two Phase 3 studies underscores the enthusiasm of the clinical investigators in the potential of this novel medical treatment. The clinical studies results have been consistent between Phase 2 and the two Phase 3 studies, highlighting the consistency of this treatment in patients with actinic keratosis. We believe KX2-391 has the potential to change the paradigm of topical therapy for Actinic Keratosis.”

Dr. Johnson Lau, Athenex’s chairman of the Board and chief executive officer, said, “Athenex would like to thank the preclinical team, the clinical team and the product development team for their significant contributions in driving the preclinical and clinical development. Athenex would also like to specifically thank the clinical investigators, who recruited patients at a rate that exceeded our expectations and contributed significantly to the advancement of the medical treatment of actinic keratosis, a condition which is considered to be pre-malignant. Athenex is currently conducting all the necessary studies and work to complete the follow up and prepare the regulatory filing.” 

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. 

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