Blog Exposure – Xenon Announced Presentation of Positive XEN1101 TMS Pharmacodynamic Phase-1 Data at 14th Eilat Conference

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LONDON, UK / ACCESSWIRE / May 17, 2018 / If you want access to our free research report on Xenon Pharma Inc. (NASDAQ: XENE), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=XENE as the Company’s latest news hit the wire. On May 15, 2018, the Company announced that it has presented positive interim data from its ongoing XEN1101 Phase-1 clinical trial in a podium presentation at the 14th Eilat Conference on New Antiepileptic Drugs and Devices (Eilat) held in Madrid, Spain. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Based on Pilot Phase-1a TMS Study, Xenon Initiated a Double-Blind, Placebo-Controlled Phase-1b TMS Study

Xenon presented interim data from its ongoing XEN1101 Phase-1 clinical trial, which is evaluating the safety, tolerability and pharmacokinetics of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101 in healthy subjects, along with results from the completed Phase-1a pilot transcranial magnetic stimulation (TMS) study in 8 healthy subjects. The pilot TMS study was designed to assess XEN1101’s ability to inhibit cortical excitability, an important CNS effect observed with anti-epileptic drugs (AEDs). Based on this pilot Phase-1a TMS study, Xenon has initiated a double-blind, placebo-controlled, randomized cross-over Phase-1b TMS study, which is expected to include around 15 to 20 healthy subjects and be completed by mid-year, with data expected in the second half of 2018.

Xenon is also likely to initiate a Phase-2 clinical trial evaluating XEN1101 as a treatment for adult focal seizures by end of 2018. The Company intends to explore a parallel plan to advance XEN1101 into rare, pediatric forms of epilepsy as soon as feasible thereafter.

Summary of Phase-1a Pilot TMS Study

The XEN1101 interim Phase-1 results include data from five SAD cohorts (n=28, placebo=6) ranging in dose from 5 to 30 mg, and one MAD cohort at a 15 mg dose (n=6, placebo=2).

Pharmacokinetic data confirms a half-life consistent with once daily dosing. Based on data generated from the MAD cohort, it is anticipated that steady state could be achieved at seven days, and food enhances the exposure of XEN1101.

The preliminary XEN1101 interim Phase-1 data suggest that overall XEN1101 is safe and well tolerated, with no serious adverse events. The most common adverse events were headache, dizziness, and drowsiness. No urinary retention or hesitation adverse events were noted, which was one of the adverse events observed in historical clinical trials with ezogabine.

The TMS Phase-1a pilot study included 8 male subjects where three doses were tested (10 mg, 15 mg, and 20 mg). In the TMS-EEG portion of the study, all three subjects at the 20 mg dose showed statistically significant modulating activity at 4 hours post dose when compared to baseline. The effects of ezogabine within a TMS-EEG have not been tested.

Based on pre-clinical in vitro metabolism studies, it is anticipated that there is a low risk of drug-drug interactions with XEN1101.

Phase-1 Pharmacokinetic Data Supports Potential for Once Daily Dosing

Dr. Simon Pimstone, CEO of Xenon, stated that the pre-clinical and interim clinical data presented, demonstrate a number of significant benefits of XEN1101 when compared to historical data for ezogabine, an earlier generation potassium channel modulator.

According to him, these benefits include both pharmacokinetic (PK) and apparent safety benefits as well as achievement of a key pharmacodynamic (PD) readout at a 20 mg dose, which around 1/20th of that reported in historical data for ezogabine. The XEN1101 PK profile from the current Phase-1 clinical trial supports the potential for once daily dosing with XEN1101 versus ezogabine’s three-times daily dosing.

Dr. Pimstone added that in order to obtain an early PD read-out, the Company used the TMS assay as a measure of cortical excitability and indicator of drug activity in the target CNS tissue. Xenon observed a robust PD effect in the TMS assay in healthy human volunteers. When compared with the historical data generated with ezogabine, XEN1101 had approximately twice the effect at significantly lower doses.

News report suggests that post the announcement of the news, shares of Xenon soared in premarket trade.

About XEN1101

XEN1101 is a Kv7 potassium channel opener being developed by Xenon for the treatment of epilepsy including: treatment-resistant adult and pediatric focal seizures as well as rare, pediatric forms of epilepsy, such as EIEE7, an early infantile epileptic encephalopathy associated with mutations in the KCNQ2 gene encoding the Kv7.2 potassium channel; and potentially other neurological disorders.

About Xenon Pharmaceuticals Inc.

Founded in 1996 and headquartered in Burnaby, Canada, Xenon Pharma is a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders.

Stock Performance Snapshot

May 16, 2018 – At Wednesday’s closing bell, Xenon Pharma’s stock dropped 4.51%, ending the trading session at $6.35.

Volume traded for the day: 175.26 thousand shares, which was above the 3-month average volume of 114.75 thousand shares.

Stock performance in the last month – up 16.51%; previous three-month period – up 71.62%; past twelve-month period – up 56.79%; and year-to-date – up 124.78%

After yesterday’s close, Xenon Pharma’s market cap was at $91.50 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.6% at the end of the session.

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