KX-01 is a small molecule developed under our Src Kinase Inhibition platform that, as a free base, has advantageous physical properties for topical ointment formulations. A topical ointment with KX-01 has shown promising results in a proof of concept clinical trial for actinic keratosis, or AK, a pre-cancerous skin lesion. We announced results of a 160-patient Phase 2a study in February of 2017 and completed enrollment of two pivotal Phase 3 studies in February of 2018. An additional indication for psoriasis is being evaluated in a Phase 1 clinical trial. Preclinical research is underway to identify further indications for KX-01, such as skin cancers and other dermatological hyperproliferative disorders. These applications provide additional potential therapeutic utilities for KX-01 ointment and could represent significant potential market expansions beyond AK.

KX-01 demonstrates at least two MOAs relevant to the control of cancer and hyper-proliferative disorders: Src tyrosine kinase inhibition (non-ATP competitive) and tubulin polymerization inhibition. Src plays a demonstrated role in regulating multiple aspects of tumor development, growth, and metastases, and its inhibition limits such tumor activity. Interfering with tubulin polymerization activity is a clinically validated mechanism for treating cancer. For both targets KX-01 binds at a novel binding site. Taken together, these two MOAs provide for a potent means of treating cancer and other hyper-proliferative disorders.

Clinical Trial Pipeline

KX01 (Ointment) Territory Indication Sponsor/Partner Pre-Clinical Phase I Phase II Phase III
KX01-AK-01-US United States Actinic Keratosis Athenex
KX01-PS-01-TW Taiwan Psoriasis PharmaEssentia
KX01-AK-002 United States Actinic Keratosis Athenex
KX01-AK-003 United States Actinic Keratosis Athenex
KX01-AK-004 United States Actinic Keratosis Athenex