Biogen’s non-opioid pain therapy did not reduce average daily pain as intended in a mid-stage study, but patients reported an overall improvement in their pain.
The Phase 2 CONVEY study investigated vixotrigine, also known as BIIB074, as an opioid alternative for patients with small fiber neuropathy. The condition causing tingling, burning pain, or other sensory symptoms is associated with diabetes or an impaired glucose metabolism.
Biogen was hoping to see an improvement in mean average daily pain compared to placebo after 12 weeks, but vixotrigine failed to meet that primary endpoint, according to a press release on Thursday. But the company claimed a narrow statistically significant change in a secondary goal, a self-reported improvement score. Patients treated with the therapy reported that they had “very much improved” or “very much better” compared to their status at the start of the study.
In one high-dose arm, Biogen also found a slight improvement in mean daily pain and a 30 percent reduction in mean daily pain, but these secondary endpoints did not reach statistical significance. The two doses of vixotrigine were generally well tolerated and no evidence of potential for abuse was found during the study.
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As for the next steps, Biogen is still looking at the CONVEY data and will reveal more in a future scientific forum. Vixotrigine is being investigated further in a phase 1 study, but Biogen has not provided any information on the indication.
The therapy is listed in the FDA’s Clinical Trials Database for various indications, most of which have already been completed. Only two studies, both phase 3 in patients with facial pain disorder trigeminal neuralgia, are listed as upcoming.
Vixotrigine has fought in the clinic before. Biogen stopped developing sciatic nerve pain in 2018 after therapy failed in a Phase 2b study.
Biogen acquired Vixotrigin by acquiring Convergence Pharmaceuticals for $ 675 million in 2015.