Auspex Making Right Moves...

(RTTNews) - Shares of Auspex Pharmaceuticals Inc. (ASPX) were up more than 63 percent in extended trading on Tuesday after the company reported positive topline results from a pivotal phase III trial of its drug candidate SD-809 for chorea associated with Huntington's disease.

Huntington's disease is an inherited, degenerative brain disorder, in which afflicted individuals lose their ability to walk, talk, think, and reason. It is estimated that about 30,000 people in the U.S. have this condition. The most common symptom of the disease is 'chorea', which refers to jerky movements of the arms and legs.

Chorea associated with Huntington's disease can be severely debilitating. The term chorea is derived from the Greek word choreia, which means "dance." The only FDA-approved treatment for chorea associated with Huntington's disease is Xenazine (tetrabenazine), developed by Denmark-based H. Lundbeck A/S.

Auspex Pharma's SD-809 is a novel inhibitor of the vesicular monoamine transporter 2 (VMAT-2). Inhibition of VMAT-2 decreases the amount of dopamine released in key regions of the brain, thereby inhibiting the involuntary movements, according to the company.

In the phase III trial of SD-809, dubbed First-HD, whose results were announced yesterday, patients taking SD-809 achieved a meaningful improvement of 2.5 points on the Total Maximal Chorea score from baseline to maintenance therapy compared to placebo. The study also demonstrated a favorable safety and tolerability profile, including low rates of depression, somnolence, akathisia/restlessness and anxiety.

Results from an analysis of the completed four-week Switch portion of clinical trial, referred to as ARC-HD study, also announced yesterday, shows that patients who switched from the current standard of care, Xenazine, to SD-809 maintained chorea control at both week one and week four. The ARC-HD trial is ongoing and it evaluates the long-term safety of SD-809.

A pivotal phase 2/3 clinical trial of SD-809 for tardive dyskinesia was initiated by the company in July of this year. The trial known as ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia), designed to enroll 90 subjects, is ongoing, and top-line data are expected in mid-2015.

Tardive dyskinesia is a neurological syndrome characterized by repetitive, involuntary body movements caused by the long-term use of certain drugs.

The second pivotal clinical trial to evaluate SD-809 in people with tardive dyskinesia, dubbed AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia), initiated in October of this year, is also underway.

The AIM-TD trial will involve approximately 200 people with tardive dyskinesia, and top-line results from this study are expected in 2016.

Another indication for which SD-809 is being tested is for the treatment of tics associated with Tourette syndrome. SD-809 is under a phase 1b study for this indication, and results are expected in mid-2015.

Tics, which refer to habitual spasmodic muscular movement or contraction, usually of the face or extremities, and uncontrollable vocal sounds, are the hallmark signs of Tourette syndrome. Neuroleptics like Orap, Haldol Risperdal, Zyprexa, Seroquel, Geodon and Abilify are some of the medications to treat tics in Tourette syndrome.

We alerted our premium subscribers to ASPX on August 4, 2014 when it was trading around $17. The stock, which closed Tuesday's (Dec.16, 2014) trading at $25.09, was up 63.41% in after-hours at $41.00.

With a couple of catalysts coming up in the next few months, it may be worth putting ASPX on your radar.