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| Statement |
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| Given the compelling data generated both in our Phase 2b X-TOLE study and ongoing open-label extension as well as from our recent X-NOVA MDD study, we continue to hear that physicians are enthusiastic about the profile of XEN1101 as we advance our late-stage development plans |
| We are incredibly excited about our strategy to pursue multiple streams of late-stage clinical development of XEN1101 in epilepsy and depression and based on our market research, see further potential for the Kv7 mechanism of XEN1101 to have even broader applicability in other neurological indications |
| Based on its unique mechanism of action and attractive product profile, we see immense opportunity for XEN1101 in epilepsy, depression and potentially other indications |
| We are encouraged and excited by physicians' enthusiasm for XEN1101 and its potential to improve the lives of patients within both the epilepsy and depression communities |
| These survey results are highly encouraging of a compelling product fit for XEN1101 in the future MDD treatment landscape |
| Our extensive know-how developed over almost two decades in ion channel drug discovery as well as our experience with potassium channels, positions us to maintain a leadership position in the Kv7 space |
| We have made strong progress in our Kv7 preclinical program in 2023, including the identification of several promising product candidates, and we expect more than one candidate will be in IND-enabling studies this year, and if successful, could enter first in-human studies next year |
| Xenon is in the fortunate position of having a strong balance sheet to support our broad and robust plans for XEN1101 and other programs in our pipeline |
| We're excited to welcome Chad and proud that Xenon continues to attract top talent across all areas of our business |
| The benefit of this program is the opportunity to generate important early derisking human proof-of-concept data |
| We are proud of the significant progress made across our pipeline in 2023, including the advancement of XEN1101 in our broad Phase 3 epilepsy program as well as strong execution in our Phase 2 X-NOVA clinical trial, which culminated in the release of topline data in late November, that demonstrated XEN1101 to have clinically meaningful drug activity in patients with major depressive disorder or MDD |
| And what we've heard very consistently in our market research is novel mechanism of action with a safety and tolerability profile that as Chris had mentioned, was actually quite favorable when compared to the epilepsy profile really resonated well |
| So I think we're uniquely positioned to do that |
| And so I think we're kind of in this really unique position where we can leverage everything we know about 1.7, which we think is an extremely well-validated target genetically but feel comfortable that the selective sodium channel inhibition approach can have therapeutic utility in the clinic |
| To echo Ian's comments, I'm proud of the many accomplishments achieved in 2023 by our development team and the advancements made across Xenon's preclinical and clinical product portfolio |
| We believe that our depth of experience in ion channel drug discovery and development will help us continue to advance and grow our robust product pipeline |
| I mean, as we've said a number of times, we're really uniquely positioned to prosecute on the target, and that's because we did the early genetics on it |
| In addition, we've now generated more than 600 patient years of safety data with some patients having been on XEN1101 for more than four years, supportive of a well-tolerated drug profile |
| Further, given the depression of the common comorbidity in epilepsy patients, efficacy in MDD could be a notable differentiator in epilepsy, particularly given that select anti-seizure medications are associated with unwanted mood symptoms |
| And as Ian indicated in his comments, we believe the X-NOVA results were compelling and supportive of continued clinical development of XEN1101 in MDD |
| So in summary, with a strong balance sheet to support our robust clinical and preclinical plans, we are looking forward to advancing and growing our broad pipeline with the goal of improving outcomes for patients in areas of high unmet medical need |
| We're grateful for the support of existing shareholders and the additional new investors who participated in our capital raise in December following the release of our Phase 2 X-NOVA data |
| Our team has made excellent progress since the release of X-NOVA, which includes completing a capital raise in December to fully fund a broad Phase 3 program in MDD and setting the date for an end of Phase 2 meeting with the FDA in April |
| So the considerable progress made in 2023 puts us in a strong position as we enter this year, where we have three key areas of focus |
| So those are the two big things that I think will increase our chance of success |
| We continue to receive overwhelmingly positive feedback on XEN1101 from both clinical investigators as well as the broader neurological community |
| We probably -- again, with the caveat of a cross-trial comparison, it looks like we have a better tolerability profile in depression |
| We've been going through this data with a fine-tooth comb and doing everything we can to understand it and largely keep continue the things that worked and refine the things that we think can improve our chance of success like decreasing two active arms down to one, that usually improves the placebo effect by a good point or so |
| But we now have clinical data available that a selective sodium channel approach, inhibition approach, [indiscernible] can yield really promising human efficacy data |
| And that's a big part of the rationale and our thinking heading into why we feel really confident in the 20-milligram selection |
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| But yeah, I would actually say that was surprising to us when we unblinded X-NOVA that the tolerability profile, and I know we had a lot of questions with investors and with analysts on what is the tolerability profile going to be like in an MDD population as we compare that to the epilepsy population and we were pleasantly surprised when we unblinded data that it looks like tolerability |
| So there isn't anything that we're doing that's really unusual |
| I mean going into it, I mean, we weren't really sure what to expect |
| It's just very probably premature to go too far down that path |
| Our results may differ materially from those projected on today's call |
| So that is a significant cost, which we don't expect will be the case for depression |
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