Xenon Pharmaceuticals Inc. (NASDAQ: XENE) shares saw a handy gain on Tuesday after the firm announced positive data from a couple of its trials. Specifically, Xenon presented data from its XEN901 Phase 1 clinical trial and from its XEN1101 Phase 1 clinical trial at the Eilat Conference on New Antiepileptic Drugs and Devices in Madrid, Spain.
Both XEN901 and XEN1101 work to treat multiple types of epilepsy, including treatment-resistant adult and pediatric focal seizures, as well as rare, pediatric forms of epilepsy, although they are ultimately different in their designations.
Dr. Simon Pimstone, Xenon’s CEO, commented:
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.
The release of the complete Phase 1 results, including the Phase 1b transcranial magnetic stimulation data from roughly 15 to 20 subjects, is anticipated in the second half of 2018. Xenon anticipates initiating a Phase 2 clinical trial evaluating XEN1101 as a treatment for adult focal seizures by year end.
The pre-clinical profile and selectivity of XEN901 suggest it may provide a significant advancement in efficacy, safety and tolerability when compared with other broadly used sodium channel blockers, including phenytoin, carbamazepine and lacosamide.
The interim Phase 1 clinical data presented today demonstrate a favorable PK profile, with XEN901 reaching levels of drug exposure significantly above where we see efficacy in our pre-clinical models with an excellent safety and tolerability profile. We are looking forward to completing the Phase 1 clinical trial over the next few months, and we are looking forward to advancing XEN901 into a Phase 2 clinical trial in adult focal seizures. In parallel, we are working on a strategy to advance XEN901 into rare pediatric forms of epilepsy, such as the EIEE13 pediatric population.
Shares of Xenon were up nearly 7% at $6.39 early Tuesday, with a consensus analyst price target of $7.00 and a 52-week range of $2.10 to $6.95. In early trading indications, the stock had been up over 16%.