Auspex Shares Soar on Late-Stage Results from Huntington’s Study

Auspex Pharmaceuticals, Deuterium, Deuterium analog

San Diego-based Auspex Pharmaceuticals (NASDAQ: [[ticker:ASPX]]) says it plans to file a new drug application by mid-2015 after reporting today that its lead drug candidate curbed involuntary movements associated with Huntington’s disease in a late-stage clinical trial.

The price of Auspex shares gained about 65 percent, leaping by more than $16 to $41.21 a share in after-hours trading on the Nasdaq exchange.

Auspex, which became a publicly traded company in February, specializes in replacing hydrogen atoms with deuterium to create longer-lasting versions of small-molecule drugs already approved by the FDA. In a statement released after the market closed, Auspex says a study of its experimental drug SD-809 on patients with the uncontrolled movements characteristic of Huntington’s hit the primary goal as well as multiple secondary endpoints for efficacy—and showed favorable safety and tolerability.

SD-809, the company’s lead drug candidate, is a deuterium-based analog of tetrabenazine (Xenazine), a drug the FDA approved four years ago for treating the involuntary movements, or chorea, associated with Huntington’s disease and other neural disorders. Tetrabenazine is not widely prescribed for Hungtington’s patients because it has relatively high side effects and requires frequent dosing.

Based on the data reported today, Auspex says it expects to file a new drug application by mid-2015 for treating Huntington’s chorea.

Huntington’s disease is a genetic disorder that causes a wide variety of symptoms, including involuntary movements and problems with behavior, emotion, thinking, and processing information. It eventually leads to death.

In addition to favorable safety and tolerability results, Auspex says its study showed low rates of depression, somnolence, anxiety, and restlessness for patients on SD-809.

Auspex says it also collected data on patients who switched from tetrabenazine, the current standard of care, to SD-809, which was given at about half the dose of tetrabenazine. Involuntary movements decreased in patients who received SD-809, according to Auspex, and the company says they could maintain chorea control.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.