XEN1101 Part 3 program for the remedy of focal onset seizures to be initiated within the second half of 2022 and New Drug Utility anticipated to be submitted after completion of first Part 3 scientific trial (X-TOLE2) together with the finished Part 2b (X-TOLE) scientific trial
Plans to provoke XEN1101 Part 3 scientific trial (X-ACKT) in an extra epilepsy indication of main generalized tonic clonic seizures
BURNABY, British Columbia, June 21, 2022 (GLOBE NEWSWIRE) — Xenon Prescribed drugs Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical firm, as we speak introduced subsequent steps in its scientific program evaluating XEN1101 for the remedy of sufferers with focal onset seizures (FOS) following the completion of an Finish-of-Part 2 (EOP2) assembly with the U.S. Meals & Drug Administration (FDA). The result of the EOP2 assembly helps the development of XEN1101 into Part 3 scientific improvement, and Xenon stays on observe to provoke the Part 3 program within the second half of 2022.
Mr. Ian Mortimer, Xenon’s President and Chief Govt Officer, said, “The profitable completion of our EOP2 assembly with the FDA marks one other necessary milestone in our XEN1101 program, and we’re excited to advance XEN1101 into Part 3 improvement. Certainly one of Xenon’s key objectives is to ship revolutionary medicines that enhance the lives of sufferers with epilepsy. Supported by the sturdy knowledge generated from our Part 2b ‘X-TOLE’ scientific trial, we imagine XEN1101 has the potential to supply a extremely differentiated and aggressive profile when in comparison with different anti-seizure medicines based mostly on its distinctive potassium channel mechanism of motion mixed with once-a-day dosing within the night with no titration. We stay up for initiating our Part 3 program to assist a deliberate NDA submission for XEN1101 with the aim of offering a brand new therapeutic possibility for sufferers with FOS.”
The EOP2 assembly was supported by nonclinical and scientific knowledge, together with outcomes from the beforehand accomplished Part 1 trials and the constructive Part 2b X-TOLE scientific trial evaluating XEN1101 in grownup sufferers with FOS. The X-TOLE topline efficacy knowledge demonstrated that the first and secondary seizure discount endpoints have been statistically vital throughout all three dose teams, with p-values of <0.001 for the 20 mg and 25 mg teams, and XEN1101 was typically nicely tolerated.
Primarily based on the EOP2 assembly, Xenon and the FDA aligned on key components of the Part 3 program to assist a New Drug Utility (NDA) submission. Xenon plans to submit an NDA upon completion of the primary XEN1101 Part 3 scientific trial ‘X-TOLE2’, if profitable, and use the present knowledge bundle from the Part 2b X-TOLE scientific trial together with further security knowledge from different scientific trials to satisfy regulatory necessities. Moreover, alignment was obtained with the FDA on key components of a single Part 3 scientific trial to pursue an extra epilepsy indication of main generalized tonic clonic seizures (PGTCS).
Dr. Christopher Kenney, Xenon’s Chief Medical Officer, commented, “We’re happy with the constructive EOP2 assembly with the FDA and are excited to provoke our XEN1101 Part 3 program within the second half of 2022. We’ve got been evaluating different potential epilepsy indications for XEN1101 and have a robust scientific rationale supporting the usage of XEN1101 to deal with PGTCS. Our analysis with key opinion leaders signifies there’s a sturdy unmet want for brand spanking new medicine with novel mechanisms of motion, significantly for sufferers experiencing persistent PGTCS regardless of remedy with different anti-seizure medicines. We count on to provoke our single Part 3 ‘X-ACKT’ scientific trial to generate the mandatory knowledge to assist a possible regulatory submission with the aim of offering a brand new remedy possibility for sufferers with PGTCS.”
About XEN1101 Part 3 Plans in Focal Onset Seizures
Xenon plans to provoke two equivalent Part 3 scientific trials referred to as X-TOLE2 and X-TOLE3, that are designed intently after the Part 2b X-TOLE scientific trial. X-TOLE2 is anticipated to be initiated within the second half of 2022 adopted by the initiation of X-TOLE3 and each research will run in parallel. These multicenter, randomized, double-blind, placebo-controlled trials will consider the scientific efficacy and security of XEN1101 administered as adjunctive remedy in sufferers with FOS. Roughly 360 sufferers will likely be randomized 1:1:1 for once-daily dosing of XEN1101 (15 mg), XEN1101 (25 mg) or placebo in every trial. Eligibility standards embody adults aged 18 to 75 years previous taking one to a few anti-seizure medicines (ASMs) with a seizure frequency of ≥4 seizures per thirty days at baseline. Sufferers will bear an 8-week baseline interval to evaluate seizure frequency and eligibility for randomization, adopted by a 12-week double blind interval (DBP). There isn’t any titration interval. The first efficacy endpoint is the median p.c change (MPC) in month-to-month seizure frequency from baseline by the DBP of XEN1101 in comparison with placebo. Key secondary endpoints embody the proportion of sufferers experiencing ≥50% discount in seizure frequency from baseline for XEN1101 versus placebo, MPC at Week 1 in comparison with baseline to evaluate the rapidity of seizure discount and the Affected person International Impression of Change (PGI-C) at Week 12. On completion of the DBP in X-TOLE2 and X-TOLE3, eligible sufferers could enter an open-label extension research for as much as three years. As well as, the continued X-TOLE open-label extension additionally continues to generate necessary long-term knowledge for XEN1101 in FOS.
About XEN1101 Part 3 Plans in Main Generalized Tonic Clonic Seizures (PGTCS)
Following the initiation of X-TOLE2, Xenon plans to provoke a single Part 3 scientific trial, referred to as X-ACKT, to assist potential regulatory submission in PGTCS. This multicenter, randomized, double-blind, placebo-controlled research will consider the scientific efficacy and security of XEN1101 administered as adjunctive remedy in sufferers with PGTCS. Roughly 160 topics will likely be randomized 1:1 for once-daily dosing of XEN1101 (25 mg) or placebo. Eligibility standards embody adults aged 18 to 75 years previous taking one to a few ASMs with a seizure frequency of ≥3 PGTCS over an 8-week baseline interval. After the baseline interval to evaluate seizure frequency and eligibility for randomization, sufferers will enter a 12-week DBP. There isn’t any titration interval. The first efficacy endpoint is the MPC in month-to-month PGTCS frequency from baseline by the DBP of XEN1101 in comparison with placebo. Key secondary endpoints embody the proportion of topics experiencing ≥50% discount in PGTCS frequency from baseline for XEN1101 versus placebo, seizure freedom and the PGI-C at Week 12. On completion of the DBP in X-ACKT, eligible sufferers could enter an open-label extension research for as much as three years.
About Main Generalized Tonic Clonic Seizures
Seizures are typically described in two main teams: generalized onset seizures and focal onset seizures. Main generalized seizures provoke in each hemispheres of the mind concurrently and are the second commonest sort of seizure skilled by individuals with epilepsy. PGTCS, also called grand mal seizures or convulsions, are extreme and life-threatening seizures comprised of tonic and clonic phases. Roughly 30% of sufferers with epilepsy have generalized seizures, which leads to a complete grownup generalized seizure affected person inhabitants of roughly 0.9 million sufferers within the U.S., of which at the very least 0.7 million sufferers expertise PGTCS. Regardless of the extra extreme seizure phenotype, fewer ASMs are at the moment accepted to deal with PGTCS in comparison with FOS and roughly 30% of PGTCS sufferers are thought of inadequately managed with preliminary strains of remedy warranting further remedy choices.
About Xenon Prescribed drugs Inc.
Xenon Prescribed drugs (Nasdaq:XENE) is a scientific stage biopharmaceutical firm dedicated to growing revolutionary therapeutics to enhance the lives of sufferers with neurological problems. We’re advancing a novel product pipeline of neurology therapies to deal with areas of excessive unmet medical want, with a deal with epilepsy. For extra data, please go to www.xenon-pharma.com.
Protected Harbor Assertion
This press launch comprises forward-looking statements inside the that means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Change Act of 1934, as amended, and the Personal Securities Litigation Reform Act of 1995 and Canadian securities legal guidelines. These forward-looking statements are usually not based mostly on historic truth, and embody statements relating to the timing of and potential outcomes from scientific trials, together with these associated to XEN1101; the potential efficacy, security profile, future improvement plans, addressable market, regulatory success and industrial potential of XEN1101; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future scientific trials for XEN1101; the efficacy of our scientific trial designs; our skill to efficiently develop and obtain milestones within the XEN1101 packages; the timing and outcomes of our interactions with regulators, our skill to efficiently develop and procure regulatory approval of XEN1101; and anticipated enrollment in our scientific trials and the timing thereof. These forward-looking statements are based mostly on present assumptions that contain dangers, uncertainties and different components which will trigger the precise outcomes, occasions, or developments to be materially completely different from these expressed or implied by such forward-looking statements. These dangers and uncertainties, a lot of that are past our management, embody, however are usually not restricted to: the impression of the continued COVID-19 pandemic on our analysis and scientific improvement plans and timelines and outcomes of operations, together with impression on our scientific trial websites, collaborators, and contractors who act for or on our behalf, could also be extra extreme and extra extended than at the moment anticipated; scientific trials could not exhibit security and efficacy of any of our or our collaborators’ product candidates; promising outcomes from pre-clinical improvement actions or early scientific trial outcomes might not be replicated in later scientific trials; our assumptions relating to our deliberate expenditures and sufficiency of our money to fund operations could also be incorrect; our ongoing discovery and pre-clinical efforts could not yield further product candidates; any of our or our collaborators’ product candidates, together with XEN1101, could fail in improvement, could not obtain required regulatory approvals, or could also be delayed to a degree the place they aren’t commercially viable; we could not obtain further milestones in our proprietary or partnered packages; regulatory companies could impose further necessities or delay the initiation of scientific trials; regulatory companies could also be delayed in reviewing, commenting on or approving any of our or our collaborators’ scientific improvement plans because of the COVID-19 pandemic, which might additional delay improvement timelines; the impression of competitors; the impression of expanded product improvement and scientific actions on working bills; impression of latest or altering legal guidelines and laws; the impression of the COVID-19 pandemic on our enterprise, adversarial situations within the basic home and international financial markets; adversarial situations from geopolitical occasions; in addition to the opposite dangers recognized in our filings with the Securities and Change Fee and the securities commissions in British Columbia, Alberta, and Ontario. These forward-looking statements converse solely as of the date hereof and we assume no obligation to replace these forward-looking statements, and readers are cautioned to not place undue reliance on such forward-looking statements. “Xenon” and the Xenon emblem are registered logos or logos of Xenon Prescribed drugs Inc. in numerous jurisdictions. All different logos belong to their respective proprietor.
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