Sinapis completes first clinical trial of lead drug for stroke and traumatic brain injury

Sinapis Pharma, Inc. is pleased to announce that it has completed its first clinical trial in the development of its lead drug for the treatment of stroke and traumatic brain injury.  The Phase I trial entitled " A Phase 1, Open-Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetics of Oral and Intravenous Administration of Methamphetamine Hydrochloride in Healthy Volunteers" was conducted at Prism Research in St. Paul, MN.

This was a single-center, open-label, randomized, two-period, two-treatment, two-sequence, single dose, crossover study of the safety and pharmacokinetics of oral and IV administration of methamphetamine HCl in six healthy volunteers.  Subjects were randomized 1:1 to receive a single oral dose of methamphetamine HCl (5 mg Desoxyn® tablet) or a single IV dose of methamphetamine HCl (5 mL of 0.5 mg/mL methamphetamine HCl injection infused over one hour for a total dose of 2.5 mg), and then crossed over to the other treatment (i.e., IV or oral dose, respectively) after a 10 day washout period.  Subjects received a single dose of study drug on Day 1 of each of the two treatment periods.

The trial successfully demonstrated the safety of an IV infusion of Methamphetamine and produced the IV infusion pharmacokinetics needed to initiate Phase IIa clinical studies in stroke patients.

Sinapis plans to initiate its Phase IIa trial in stroke patients before year end.

Dr Donald Picker, Sinapis CEO, said  "We are very pleased  and excited to complete the next step in the development of this drug for stroke and traumatic brain injury patients. We are eager to begin the proof of principle trials in these very important indications where there are currently no effective treatments."