FDA approves SeneXta IND for Alzheimer's

Swiss biopharmaceutical company SeneXta has received US FDA approval of its Investigational New Drug (IND) application for SNX-001, a treatment for Alzheimer's Disease. SeneXta expects clinical dosing to begin in September.

Enrico Braglia, ceo of SeneXta, said: "We are delighted that the FDA has accepted our SNX-001 data package to allow us to begin a Phase I clinical trial. In less than ten months since we committed to this project, we have completed manufacturing, nonclinical toxicology, clinical design and we are ready to start new clinical testing."

SeneXta will conduct the Phase I single and multiple dose escalation clinical trial in Germany. The Hamburg Ethical Committee has already approved the trial.

The Phase I dosing is designed to reach the previously observed therapeutic dose in Alzheimer's patients. Results from this trial will be supportive for a second randomised, double-blind placebo-controlled Phase II trial already under design.

SNX-001 is a selective inhibitor of acetylcholinesterase (AChE) for the treatment of Alzheimer's disease. According to SeneXta It produces long-acting AChE inhibition, which improves its brain selectivity and reduces the peripheral toxicity (nausea, vomiting, and diarrhoea) that limits the utility of short-acting inhibitors.