Xenon Shines Bright On Focal Epilepsy Drug Data, What Next?

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Shares of Xenon Pharmaceuticals Inc. (XENE) closed Monday's trading at an all-time high of $31.50, gaining more than 100%, thanks to promising mid-stage data for focal epilepsy drug XEN1101.

The phase 2b clinical trial, dubbed X-TOLE, which evaluated the clinical efficacy, safety, and tolerability of XEN1101, administered as adjunctive treatment in adult patients with focal epilepsy, met its primary efficacy endpoint and key secondary measures.

Focal epilepsy is a neurological condition, in which an epileptic seizure starts in one side of the brain. It is estimated that about 3.4 million people in the U.S. have epilepsy. Focal epilepsies account for around 60% of all seizure disorders, according to reports.

XEN1101 demonstrated a statistically significant and dose-dependent reduction from baseline in monthly focal seizure frequency when compared to placebo, achieving the primary efficacy endpoint.

A key secondary endpoint of the study was a responder analysis, which compared the proportion of study subjects treated with XEN1101 who achieved a "more than or equal to 50% reduction" in monthly focal seizures versus placebo. The percentage of subjects who achieved a over 50% reduction in monthly focal seizures was 54.5% in the XEN1101 25 mg group, 43.1% in the XEN1101 20 mg group, and 28.3% in the XEN1101 10 mg group compared to 14.9% in the placebo group, according to the company.

Given the compelling topline results of XEN1101, the company is planning for an expedited development path moving forward.

XEN1101 is also being explored in neurological indications outside of epilepsy.

An investigator-sponsored phase 2 proof-of-concept clinical trial of XEN1101 for the treatment of major depressive disorder (MDD) and anhedonia is expected to be initiated in the coming months.

A company-sponsored clinical study of XEN1101 in MDD is also being planned.

The other drug candidates in the pipeline are XEN496 for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE), and XEN007 that is being studied in treatment-resistant absence seizures and potentially other neurological disorders.

-- A phase 3 multicenter clinical trial evaluating the efficacy, safety, and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE, dubbed the "EPIK" study, is underway.

-- An investigator-led phase 2 proof-of-concept study is ongoing to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant absence seizures. Promising interim data from this trial were reported last December and additional results are anticipated by the end of this year.

In addition, Xenon has two partnered programs - XEN901, now known as NBI-921352, and FX301.

NBI-921352, being developed in collaboraton with Neurocrine Biosciences (NBIX), for the treatment of focal-onset seizures in adults, is expected to enter a phase 2 clinical trial later this year.

FX301, a partnered program with Flexion Therapeutics (FLXN), consists of Xenon Pharma's XEN402 formulated for extended release from a thermosensitive hydrogel.
A phase Ib proof-of-concept trial evaluating the safety and tolerability of FX301 administered as a single-dose, popliteal fossa block (a commonly used nerve block in foot and ankle-related surgeries) in patients undergoing bunionectomy, conducted by Flexion is underway. Data from this trial is expected in late 2021.

Cash position:

Xenon Pharma's cash, cash equivalents and marketable securities totaled $260.5 million as of June 30, 2021.

Taking advantage of yesterday's surge in share price, the company has commenced an underwritten public offering of $250 million of its common shares pursuant to its existing shelf registration statement.

Xenon Pharma was trading around $8 when we alerted our premium subscribers to the stock for the first time on Jan.27, 2017.

On Sep.4, 2018, we had again alerted readers to XENE when it was trading around $13. When we alerted readers to XENE last February, it was trading around $16.

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XENE has traded in a range of $9.32 to $32.35 in the last 1 year.

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