Med Check

Amygdala Acquires Anti-Addiction Drug From Gilead

Amygdala Neuroscience Inc. announced in February that it has acquired Gilead’s pharmacoagent for addiction GS-6637.

GS-6637 is an aldehyde dehydrogenase 2 (ALDH 2) inhibitor that suppresses production of dopamine. Previous studies in animals suggested the medication decreases drug use and relapse by preventing stimuli-induced dopamine surges.

Peter Strumph, Amygdala’s co-founder and CEO, said in a press statement that the company expects to launch phase 2 trials evaluating the medication for the treatment of cocaine and alcohol use disorders later this year.

Accera’s Alzheimer’s Therapy AC-1204 Fails in Phase 3 Trial

Accera Inc. announced in February that its once-daily compound AC-1204 (caprylic triglyceride)—designed to restore cellular metabolism in neurons of patients with Alzheimer’s disease—missed a primary endpoint in a phase 3 clinical trial.

According to the company, patients with mild-to-moderate Alzheimer’s disease who took AC-1204 for 26 weeks failed to show cognitive improvements, as measured by the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog).

Accera President and CEO Charles Stacey, M.D., said in press statement that the outcome was unexpected since patients in a phase 2 study of AC-1204 “exhibited a statistically significant improvement of greater than 3 points in ADAS-Cog.”

A pharmacokinetic analysis by Accera showed that the version of AC-1204 used in the trial was associated with a lower drug concentration in plasma compared with prior drug formulations—a finding the company suggested may be to blame for the negative findings.

FDA Grants Teva Priority Review For Tardive Dyskinesia Therapy

Teva Pharmaceutical Industries Ltd. in February announced that the Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia. The agency also granted a Priority Review designation for SD-809, which allows for a faster evaluation of applications for drugs that could lead to significant improvements of serious health conditions.

SD-809 is small-molecule inhibitor of the vesicular monoamine 2 transporter known as VMAT2.

The NDA for SD-809 is based on the results of two phase 3 studies, including the AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia) that involved 288 patients with moderate to severe TD. Results from the study showed that after 12 weeks of treatment, people who received daily doses of 12 mg, 24 mg, or 36 mg of SD-809 were at least twice as likely to show improvements in TD symptoms than those who received placebo.

According to a press release by Teva, the FDA is expected to make a final decision on SD-809 for the treatment of TD by August 30.

Companies Begin Marketing Generic Version of Pristiq

In March, Lupin Limited, Breckenridge Pharmaceutical Inc., and Teva Pharmaceuticals Industries Ltd. all began marketing generic versions of Pfizer’s Pristiq (desvenlafaxine succinate extended-release tablets).

Pristiq, which as of December 2016 had annual sales in the United States of approximately $883 million, is indicated for the treatment of major depressive disorder.

The generic versions of the selective serotonin and norepinphrine reuptake inhibitor marketed by Lupin and Breckenridge will be available in 50 mg and 100 mg tablets. Teva’s generic version will be manufactured in 25 mg, 50 mg, and 100 mg tablets. 

Merck Halts BACE1 Inhibitor Study For Mild-to-Moderate Alzheimer’s

Merck announced in February it is discontinuing its phase 2/3 EPOCH trial, which was comparing the outcomes of patients with mild-to-moderate Alzheimer’s disease taking oral verubecestat daily for 78 weeks with patients receiving the standard of care. Verubecestat is a small-molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 known as BACE1.

The announcement came after an external committee assessing the overall benefit/risk of the medication concluded there was “virtually no chance of finding a positive clinical effect.”

Merck is moving forward with its phase 3 clinical program APECS, a 104-week trial measuring the effectiveness of verubecestat (12 mg and 40 mg) in patients with prodromal Alzheimer’s disease. APECS results are expected by 2019. ■