Xenon Pharmaceuticals Outlines Key Milestone Opportunities For 2024; Completion Of Patient Enrollment In XEN1101 Phase 3 X-TOLE2 Clinical Trial In Focal Onset Seizures Anticipated In Second Half Of 2024

Author: Benzinga Newsdesk | January 08, 2024 09:15am

Completion of Patient Enrollment in XEN1101 Phase 3 X-TOLE2 Clinical Trial in Focal Onset Seizures Anticipated in Second Half of 2024

 

XEN1101 Phase 3 Program in Major Depressive Disorder Planned for Initiation in 2024

VANCOUVER, British Columbia, Jan. 08, 2024 (GLOBE NEWSWIRE) --  Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today outlined progress within its pipeline programs and key milestones for 2024.

Mr. Ian Mortimer, Xenon's President and Chief Executive Officer, stated, "We enter this year well positioned to continue to execute on our broad XEN1101 clinical program, which represents the most advanced potassium channel modulator in clinical development for multiple indications. Most recently, the data we generated in our Phase 2 proof-of-concept X-NOVA clinical trial demonstrated clinically meaningful drug activity in depression, in addition to further supporting XEN1101's highly differentiated profile in epilepsy. With a strong financial position, we are actively planning for late-stage development of XEN1101 in depression and evaluating potential development in additional neurological indications, as we believe this mechanism potentially has broad applicability."

Mr. Mortimer added, "We also remain focused on our goal to improve outcomes for epilepsy patients where there continues to be a significant need for new, differentiated anti-seizure medications. We continue to progress our Phase 3 epilepsy clinical trials and importantly, we anticipate that patient enrollment in X-TOLE2 will be completed in the second half of this year. In addition, the ongoing XEN1101 Phase 2b X-TOLE open label extension epilepsy study has now collected over 500 patient years of data and has been extended from five to seven years. Our interim analyses completed to date have continued to demonstrate compelling efficacy data and seizure freedom rates, while building upon the safety and tolerability profile of XEN1101."

Mr. Mortimer continued, "In addition to our clinical stage programs, we continue to conduct important pre-clinical work that leverages our expertise in ion channel drug development, and we expect multiple drug candidates will enter IND-enabling studies in 2024 and 2025 with a focus on our leadership in the Kv7 space as well as new potential opportunities targeting Nav1.1 for seizure disorders and Nav1.7 for pain. We expect to provide additional updates as these discovery programs advance through IND-enabling studies and into clinical development."

Pipeline Programs and Anticipated Milestones

XEN1101

XEN1101 is a novel, potent Kv7 potassium channel opener being developed for the treatment of epilepsy, major depressive disorder (MDD), and potentially other neurological disorders.

XEN1101 for Epilepsy (Focal Onset Seizures)

Xenon's XEN1101 Phase 3 epilepsy program includes two identical Phase 3 clinical trials, called X-TOLE2 and X-TOLE3, that are designed closely after the Phase 2b X-TOLE clinical trial. These multicenter, randomized, double-blind, placebo-controlled trials are evaluating the clinical efficacy, safety, and tolerability of 15 mg or 25 mg of XEN1101 administered with food as adjunctive treatment in approximately 360 patients per study with focal onset seizures, or FOS. Xenon anticipates that patient enrollment in X-TOLE2 will be completed in the second half of 2024.

XEN1101 for Epilepsy (Primary Generalized Tonic-Clonic Seizures)

Xenon's Phase 3 X-ACKT clinical trial is intended to support potential regulatory submissions in an additional epilepsy indication of primary generalized tonic-clonic seizures, or PGTCS. This multicenter, randomized, double-blind, placebo-controlled study is evaluating the clinical efficacy, safety, and tolerability of 25 mg of XEN1101 administered with food as adjunctive treatment in approximately 160 patients with PGTCS.

XEN1101 for Epilepsy (Open-Label Extension)

Upon completion of the double-blind period in X-TOLE2, X-TOLE3, or X-ACKT, eligible patients may enter an open-label extension, or OLE, study for up to three years. In addition, the ongoing X-TOLE Phase 2b OLE continues to generate important long-term data for XEN1101.

XEN1101 for Major Depressive Disorder

In November 2023, Xenon reported promising topline results from the Phase 2 proof-of-concept X-NOVA clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 10 mg and 20 mg of XEN1101 in 168 patients with moderate to severe MDD. Xenon is actively assessing various clinical and regulatory pathways to support late-stage clinical development of XEN1101 in MDD and expects to initiate the Phase 3 clinical program in 2024. Xenon is also evaluating other potential indications for the future development of XEN1101.

In addition, Xenon is collaborating with the Icahn School of Medicine at Mount Sinai to support an ongoing investigator-sponsored Phase 2 proof-of-concept, randomized, parallel-arm, placebo-controlled multi-site study of XEN1101 for the treatment of MDD in approximately 60 subjects.

Partnered Programs

Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a selective Nav1.6 sodium channel inhibitor. A Phase 2 clinical trial is underway evaluating NBI-921352 in patients aged between 2 and 21 years with SCN8A developmental and epileptic encephalopathy.

Pre-Clinical Programs

Xenon continues to leverage its extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. The near-term focus is on development candidates targeting Kv7, Nav1.1 and Nav1.7 where Xenon expects multiple candidates will enter IND-enabling studies in 2024 and 2025. Additional updates will be provided as these pre-clinical drug candidates advance through IND-enabling studies and into clinical development.

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