Avanir Pharma has chalked up a win for the first late-stage study for AVP-786 in Alzheimer’s agitation, laying the groundwork for a high-risk, high-reward Phase III program.
The Otsuka subsidiary kept things general, divulging only that one of the two doses tested in the study induced a significant improvement for patients with moderate-to-severe agitation on the Cohen-Mansfield Agitation Inventory; in the other dose arm, improvement was “numerical but not significant.”
The trial employed a special, two-part protocol called sequential parallel comparison design, where 410 patients are divided into the drug and placebo arms in an initial 6-week stage, and in the second stage of the same duration non-responders in the placebo cohort were re-randomized to receive either AVP-786 or sham treatment again. It’s an approach intended to maximize the clinical data on a given drug.
Avanir’s celebration comes as the Alzheimer’s field is still rattled by Biogen and Eisai’s decision to terminate their much-watched aducanumab Phase III just days ago, another blight to the years-long and multibillion dollar effort to find ways to halt, slow or alleviate symptoms of the memory-wasting disease.
Sanjay Dubé, VP of R&D and head of clinical development & scientific strategy at Avanir, underscored the point: “Currently there is no FDA-approved treatment for agitation in patients with Alzheimer’s dementia. Any advancement in the treatment and management of agitation in patients with Alzheimer’s dementia would help to bridge the treatment gap in these patients.”
A number of other biotechs have attempted to tackle the agitation associated with the disease, including Avanir’s own parent Otsuka, whose blockbuster therapy Rexulti (brexpiprazole) offered some mixed data in Phase III. BioXcel and GW Pharma are testing their own approaches with a formulation of dexmedetomidine and a cannabinoid, respectively.
AVP-786 is a second-generation version of Nuedexta — a neuro drug embroiled in a marketing scandal — that’s tweaked to prolong the exposure of the dextromethorphan component in the body (the drug also contains quinidine).
Avanir is conducting two other studies as part of the Phase III agitation program. Both of them use a conventional parallel-arm design.
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