Last $19.44 USD
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Volume 121.3K
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As of 8:10 PM 07/29/14 All times are local (Market data is delayed by at least 15 minutes).

auspex pharmaceuticals inc (ASPX) Snapshot

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auspex pharmaceuticals inc (ASPX) Details

Auspex Pharmaceuticals, Inc., a biopharmaceutical company, focuses on developing and commercializing novel medicines for the treatment of orphan diseases. The company’s product candidates are used to address medical needs primarily in hyperkinetic movement disorders, such as chorea associated with Huntington’s disease, tardive dyskinesia, and Tourette syndrome, as well as other orphan indications. Its lead product candidate includes SD-809 that is in Phase 3 registration clinical trial for the treatment of chorea associated with Huntington’s disease. The company’s other product candidates comprise SD-254, deuterium-containing form of venlafaxine, which has completed two Phase 1 clinical trial, as well as preclinical stage of development products include SD-560, a deuterium-containing form of pirfenidone; SD-970, a deuterium-containing form of tofacitinib, and a deuterium-containing form of ketamine. Auspex Pharmaceuticals, Inc. was founded in 2001 and is based in San Diego, California.

24 Employees
Last Reported Date: 05/14/14
Founded in 2001

auspex pharmaceuticals inc (ASPX) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $592.5K
Chief Medical Officer
Total Annual Compensation: $291.2K
Vice President of Research
Total Annual Compensation: $287.5K
Compensation as of Fiscal Year 2013.

auspex pharmaceuticals inc (ASPX) Key Developments

Auspex Pharmaceuticals Initiates Pivotal Phase 2/3 Clinical Trial for SD-809 in Tardive Dyskinesia

Auspex Pharmaceuticals, Inc. announced the enrollment of the first two patients in a multi-center pivotal Phase 2/3 clinical trial of its investigational drug, SD-809 (deutetrabenazine), for the treatment of tardive dyskinesia (TD). Top-line data from the trial, designated the ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) study, are expected in mid-2015. The ARM-TD Phase 2/3 clinical trial of SD-809 for the treatment of drug-induced tardive dyskinesia will involve approximately 90 subjects with moderate to severe TD, who will be randomized 1:1 to receive SD-809 or placebo. Patients will titrate to their optimal dosage over six weeks, and be treated at that dose for six weeks, for a total of 12 weeks of treatment. The primary efficacy endpoint will be the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end therapy, which will be assessed by centralized video rating. The safety endpoints include adverse events, vital signs, physical/neurological/laboratory examinations and ECGs. Eligible subjects who complete the Phase 2/3 clinical trial will be offered a long-term safety follow-up. Auspex also plans to initiate an additional Phase 3 pivotal clinical trial of SD-809 for the treatment of TD in 2014.

Auspex Pharmaceuticals Seeks Acquisitions

Auspex Pharmaceuticals, Inc. (NasdaqGM:ASPX) seeks acquisitions. Auspex Pharmaceuticals has filed a Follow-on Equity Offering of $69 million. Auspex Pharmaceuticals plans to use the proceeds to fund an additional Phase 3 pivotal clinical trial of SD-809 in patients with tardive dyskinesia; for research and development, including, but not limited to funding future clinical and regulatory expenses related to SD-809 and related to the NDA filing and launch of SD-809, if approved, for the treatment of chorea associated with Huntington’s disease; and for working capital and other general corporate purposes, including making monthly principal and interest payments on our credit facility. Auspex Pharmaceuticals may also use a portion of the net proceeds to in-license, acquire, or invest in complementary businesses, technologies, products or assets.

Auspex Pharmaceuticals, Inc. Announces Data from Interim Analysis of ARC-HD Switch Trial Demonstrating Clinical Activity of SD-809

Auspex Pharmaceuticals, Inc. announced results from a pre-specified interim subgroup analysis of the ongoing open-label ARC-HD Switch study in which the clinical experience of switching subjects' treatment from tetrabenazine to SD-809 was evaluated. The interim analysis was conducted to determine whether chorea control was maintained after converting subjects with Huntington's disease (HD) from stable doses of tetrabenazine to SD-809, which is administered in lower doses and with a simplified dosing regimen. In accordance with the pre-specified interim analysis plan, 12 subjects were included in the subgroup analysis, all of which had chorea assessed one week after switching from tetrabenazine to SD-809 and eight of which had chorea assessed four weeks after switching (the remaining four subjects had not yet reached the four-week point in the study at the time of the pre-specified interim analysis). At one and four weeks after switching to SD-809, the mean total chorea score decreased by approximately one point from baseline (week one change for 12 subjects was -0.83 +/-0.51 and week 4 change for eight subjects was -0.75 +/-0.75, mean and standard error), indicating that SD-809 maintained chorea control in these subjects. The conversion to SD-809 was generally well tolerated as no subject prematurely discontinued from the study, there were no adverse events of loss of chorea control and no serious adverse events were reported. The adverse events reported to date in these interim analysis subjects during treatment with study drug were mild or moderate, with dry eye and dry mouth (one subject), fall (two subjects) and back pain (one subject), none of which were deemed related to study drug; and one subject with mood altered, deemed possibly related to study drug. The ARC-HD Switch study is ongoing and further assessments of safety, tolerability and chorea control in these and additional subjects will be made to confirm these interim findings.


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