flunarizine (XEN007) / Xenon - LARVOL DELTA

Xenon Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Xenon Pharmaceuticals Inc...today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update....To date, a total of eight subjects have been enrolled in an investigator-led Phase 2 proof-of-concept study examining the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant absence seizures, including childhood absence epilepsy and juvenile absence epilepsy. Given the prioritized focus on the development plans for XEN1101 and XEN496, Xenon is not planning any company-sponsored XEN007 development activities in 2022."

Enrollment status • Absence Seizure Disorder • CNS Disorders • Epilepsy

Xenon Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Research and development expenses for the quarter ended March 31, 2021 were $16.3 million, compared to $11.8 million for the same period in 2020. The increase of $4.5 million was primarily attributable to increased spending on Xenon’s clinical development product candidates XEN496 and XEN1101, and, to a lesser extent, increased spending on pre-clinical, discovery and other internal programs."

Commercial • CNS Disorders • Epilepsy

Xenon Pharmaceuticals Reports 2020 Financial Results and Provides Corporate Update (Xenon Pharmaceuticals Press Release) - "...Xenon’s 'X-TOLE' study is an ongoing Phase 2b clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy....Xenon anticipates that patient randomization will be completed in the first half of 2021, with topline data anticipated in the third quarter of 2021, dependent upon ongoing patient enrollment rates....XEN007...given the impact of COVID-19 on recruitment, Xenon continues to work with its collaborator to expand the study to include additional sites and expects that topline results from a larger data set will now be available in the second half of 2021. Xenon expects to make a decision in 2021 regarding the future development of XEN007 in CAE."

Clinical data • Enrollment status • P2b data • Trial status • CNS Disorders • Epilepsy

[VIRTUAL] A Phase 2 Open Label Study of XEN007 (Flunarizine) for Treatment Resistant Absence Seizures (AES 2020) - "Flunarizine has demonstrated efficacy in experimental models of absence seizures including both the pentylenetetrazole (PTZ) and gamma hydroxybutyrate (GHB) induced absence seizures in rats, when either administered independently or in combination with valproic acid or ethosuximide. Supported by excellent clinical safety/tolerability in children, in-vitro mechanism of action against T calcium channels and in-vivo CAE pharmacology data, XEN007 is being tested as a potential treatment for CAE. Top line data is expected to be presented at the AES in 2020. Funding: Grant from Xenon-Pharma to support research assistant, pharmacy costs and medication cost"

Clinical • P2 data • Absence Seizure Disorder • CNS Disorders • Epilepsy • Migraine • Otorhinolaryngology • Vertigo

Xenon Pharmaceuticals reports first quarter 2020 financial results and provides corporate update (GlobeNewswire) - “Looking specifically at our proprietary epilepsy programs, we anticipate top-line data in the first half of 2021 from the XEN1101 Phase 2b “X-TOLE” clinical trial currently underway in adult focal epilepsy, and we continue to analyze other potential clinical indications for this novel Kv7 potassium channel modulator....The XEN496 Phase 3 clinical trial is expected to be initiated in 2020....A physician-led, Phase 2 proof-of-concept study is examining the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy, or CAE. Results from this Phase 2 study are expected in 2020, dependent upon patient enrollment rates given the ongoing COVID-19 pandemic."

New P3 trial • P2 data • CNS Disorders • Epilepsy

Edited Transcript of XENE earnings conference call or presentation 9-Mar-20 (Yahoo Finance) - "The FDA granted orphan drug designation for the treatment of hemiplegic migraine with XEN007."

Orphan drug

Xenon Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Corporate Update (GlobeNewswire, Xenon Pharmaceuticals Inc.) - "...plans to test XEN496 in healthy adult volunteers in a pharmacokinetic (PK) study that we expect to initiate in the third quarter of 2019. Xenon expects to file an Investigational New Drug (IND) application in the fourth quarter of 2019 in order to initiate a Phase 3 clinical trial in KCNQ2-DEE....XEN1101...Depending upon the rate of enrollment, top-line results are anticipated in the second half of 2020....Xenon intends to run a PK study in healthy adult volunteers with the new XEN901 pediatric formulation beginning in the third quarter of this year, followed by an IND submission to start a proposed Phase 2 or 3 clinical trial in SCN8A-EE patients."

Clinical • New trial • P2b data • Regulatory