Xenon drug misses main goal of depression study
27 Nov 2023
Clinical ResultClinical Study
Dive Brief:
Xenon Pharmaceuticals, a Canada-based biotechnology company, on Monday said its main experimental drug did not meet the central goal of a mid-stage clinical trial that tested it in people with major depressive disorder.
However, Xenon believes there were enough positive findings to warrant further study of the drug, called XEN1101, in depression. The company is “actively exploring the future development of XEN1101 in MDD and potentially other indications as we believe this mechanism has potential broad applicability,” CEO Ian Mortimer said in a statement.
Dive Insight:
In the outer membrane of virtually all cells, there are passageways that allow large, charged particles to enter and exit. One of the most common regulates potassium ions and is involved in many essential cell activities, including the process by which neurons communicate with each other.
Xenon designed its drug to keep some of those potassium channels open for longer and, therefore, keep them from firing as often. Research suggests that such an effect could help combat certain diseases of the brain and central nervous system.
Xenon’s depression study was meant to serve as a “proof-of-concept” that its drug works as intended in the treatment of depression. It evaluated 168 patients with moderate to severe major depressive disorder over a six-week period, with participants on either a placebo, a lower, 10 mg dose of XEN1101 or a higher, 20 mg dose.
The study’s primary measure was a depression rating scale known, in short, as MADRS. On that scale, higher scores reflect more severe depression. According to Xenon, the average reduction in score over the treatment period was 13.9 for the placebo group, 15.6 for the low-dose drug group and 16.9 for the high-dose drug group.
Those results, Xenon said, reflect a “clear dose response” and a “clinically meaningful, but not statistically significant” difference between the patients given the higher drug dose and those on placebo.
Xenon also highlighted several other supportive data points. On a separate depression rating scale called HAM-D17, the difference in score reduction between the high-dose and placebo groups was statistically significant. So was the change on the “SHAPS,” a scoring system that measures the inability to feel pleasure.
Regarding safety, Xenon said patients tolerated its drug well. In the high-dose arm, 18% felt dizziness following treatment. Close to 11% experienced drowsiness, while headache and “disturbance in attention” were each seen in 9%. The respective rates for those adverse events in the placebo group were 7%, 2%, 13% and 0%.
Christopher Kenney, Xenon’s Chief Medical Officer, said the results were encouraging and support the drug’s “potential to play an important role” in addressing the inability to feel pleasure. “Overall, there continues to be a strong need for new treatment options for MDD, and we believe XEN1101 has attractive qualities,” he said.
Investors appeared to share that optimism, as Xenon’s stock price surged about 15%, to above $33, by late morning Monday.
Perhaps that’s because investor attention has been mostly directed at Xenon’s epilepsy programs. In a note to clients, RBC Capital Markets analyst Brian Abrahams wrote that most of Wall Street was “likely not certain [XEN1101] would have any antidepressant activity at all.” As such, Abrahams views overall results as a “net win” for Xenon.
The team at Jefferies argues, too, how the “bar” for success in Xenon’s depression study was “fairly high.” That bar, according to analyst Andrew Tsai, would have patients on the drug showing a four-point or greater change on the MADRS scale compared to the placebo group, in addition to no surprise adverse events.
Given that Xenon’s drug works differently than currently available treatments for epilepsy and depression, Tsai estimates that XEN1101, should it gain approval, could generate north of $1 billion in each of those indications.
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