Xenon Pharmaceuticals Inc (NASDAQ: XENE) is having a great start to the trading session in the pre-market hours this morning, and for good reason. The company presented positive data from an ongoing Phase 1 clinical trial, exciting investors and sending the stock on a tear for the top. Today, we’ll talk about:
- The data presentation;
- what we’re seeing from the stock;
- and what we’ll be watching for with regard to XENE ahead.
XENE Presents Positive Clinical Data
As mentioned above, Xenon Pharmaceuticals is having an overwhelmingly strong start to the trading session after presenting clinical data. The data came from the ongoing XEN1101 Phase 1 clinical trial and was provided through a podium presentation at the 14th Eilat Conference on New Antiepileptic Drugs and Devices.
In the release, XENE said that XEN1101 is a Kv7 potassium channel opener designed for the treatment of epilepsy. This includes treatment-resistant adult and pediatric focal seizures as well as rare, pediatric forms of epilepsy. The data showed that the study proved to be positive, inhibiting cortical excitability. As a result, the company has initiated a double-blind, placebo-controlled, randomized cross-over Phase 1b TMS study. In the study, the company expects to enroll 15 to 20 healthy patients and data is expected in the second half of 2018. In a statement, Dr. Simon Pimstone, CEO at XENE, had the following to offer:
The interim XEN1101 Phase 1 clinical data presented today are very exciting. We believe 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. 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 approximately 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. From a safety perspective, the majority of adverse events were mild and resolved spontaneously, with an overall profile showing XEN1101 as safe and well tolerated. Importantly, this safety has been observed at drug exposures where we have now shown XEN1101 having an inhibitory effect on cortical excitation in humans.
In order to obtain an early PD read-out, we used the TMS assay as a measure of cortical excitability and indicator of drug activity in the target CNS tissue. We are pleased to see 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.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In this particular case, the news proved to be overwhelmingly positive. After all, positive data is leading the company from a Phase 1a clinical trial to a Phase 1b. So, it’s no surprise that excited investors are sending the stock on a run for the top. At the moment (9:02), XENE is trading at $7.00 per share after a gain of $1.00 per share or 16.67% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on XENE. In particular, we’re interested in following the continued development of XEN1101 as the treatment seems to be producing promising results. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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