- An experimental pain drug helped alleviate pain in patients with a type of chronic neuropathy, Biogen said, reporting Thursday the results of a Phase 2 trial that tested the therapy against a placebo. Called vixotrigine, the drug blocks a pathway connecting pain-sensitive neurons that respond to tissue damage.
- Patients with small fiber neuropathy who received a twice-daily 200 milligram dose had a significantly lower score than those taking a placebo on a patient-reported scale 12 weeks after beginning treatment. A 350 milligram dose didn't meet statistical significance on that scale, the trial's main measure, although Biogen pointed to success on a secondary goal.
- Biogen was significantly boosted earlier this year by the controversial approval of its Alzheimer's disease drug Aduhelm. Faced with sluggish uptake, however, the company is spending time talking up its pipeline of would-be drugs like vixotrigine, too. Biogen has scheduled an event next week to discuss its research & development efforts with investors and analysts.
With opioid-based painkillers under scrutiny, biotech companies are exploring new mechanisms of action to ease discomfort from chronic conditions as well as acute settings like post-surgical care. Development of new pain drugs can be difficult, however, because of differences in how patients experience pain as well as the "placebo effect" that can convince patients on placebo that they have received an active medication.
Vixotrigine, formerly called BIIB074, targets a neural pathway called NAV1.7, identified in patients with a mutation that caused a loss of function in that pathway and made them impervious to pain.
Biogen is testing vixotrigine in a couple of disorders: small fiber neuropathy and trigeminal nerualgia, a rare pain condition that affects the side of the side of the face. The trial results reported Thursday were in small fiber neuropathy, which frequently occurs in patients with diabetes but can also have no immediate identifiable cause.
Patients enrolled in the trial all received a 350 milligram twice-daily dose of vixotrigine at the beginning of the trial, and then were randomized to continue on 350 milligrams, to take 200 milligrams twice daily or to take a placebo.
At 12 weeks, patients taking the 200 milligram dose reported a statistically significant reduction in the average daily pain scale, an 11-point measure, when compared to patients taking a placebo. Patients in the 350-milligram arm didn't, however, although Biogen pointed to a statistically significant difference on a scale called Patient Global Impression of Change, a seven-point scale that measures patients' overall health status.
Moreover, the statistical measure used to assess whether the drug had a significant effect only narrowly met the threshold for positive results for the 200 milligram dose.
In a press release, Biogen said the "totality of the data" from this Phase 2 study will be used to help it design pivotal trials aimed at winning regulatory approval.
Biogen terminated the study early, according to the record in the clinicaltrials.gov. Per a company spokesperson, the early termination was done "in order to progress to readout and learn from the data promptly."
In reporting mid-stage data on a NAV1.7 agent, Biogen is ahead of rival Vertex in reporting a similarly acting agent. Vertex has initated Phase 2 trials of an experimental NAV1.8 drug called VX-548 in patients recovering from surgery.