Anavex Life Sciences Corp (AVXL)

[Investor2014]

Compared to the unexpected therapeutic response across several Alz symptoms on the HAM-D scale that A2-73 have shown in P2, below PR from Lundbeck seems weak.

LUN: Otsuka and Lundbeck announce improvement of agitation symptoms related to Alzheimer’s-type dementia following treatment with brexpiprazole relative to placebo
Valby, Denmark, 2017-05-02 09:10 CEST (GLOBE NEWSWIRE) --
Valby, Denmark, 2 May 2017 - H. Lundbeck A/S (Lundbeck) and Otsuka
Pharmaceutical Co., Ltd. (Otsuka) announce top-line results from two phase III clinical trials evaluating the efficacy, safety and tolerability of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer’s type.

The primary endpoint of both trials was change from baseline in the
Cohen-Mansfield Agitation Inventory (CMAI) total score, a 29-item scale to systematically assess the symptoms of agitation. The key secondary endpoint was the change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score, a 7-point scale assessing overall severity of the patient’s agitation. These studies were done in multiple countries in North America and Europe, and in the Russian Federation.

In both studies, patients treated with brexpiprazole showed improvements in symptoms of agitation relative to placebo. In the first study, the improvements in the primary endpoint of CMAI for 2 mg brexpiprazole were statistically better than placebo (p<0.05) and appeared more robust than the improvements on the key secondary endpoint of CGI-S (p>0.05). In the second study, the improvements in the primary endpoint of CMAI (p>0.05) appeared less robust than the improvements on the key secondary endpoint of CGI-S (p<0.05). In both studies, there was variability in the data from different countries, perhaps associated with differing standards of care; the data from Russian sites showed especially poor separation between placebo and drug.

Regarding safety and tolerability, both studies confirmed the profile of
brexpiprazole as observed in the clinical trials for schizophrenia and for adjunctive treatment of major depressive disorder (MDD). The most common adverse events in patients receiving brexpiprazole versus placebo (incidence >3% and greater than placebo) were insomnia (4.7% vs. 3.3%), agitation (3.5% vs. 2.9%), and somnolence (3.3% vs. 2.2%). Overall mortality during the studies was low (0.86%) and none of the deaths were considered to be related to treatment.