Altasciences is supporting Alzamend Neuro, Inc. in advancing a novel treatment for dementia related to Alzheimer’s disease. In addition to having conducted Alzamend’s Phase IIa multiple ascending dose (MAD) clinical trial in healthy subjects, Altasciences is continuing to provide clinical monitoring, project management, biostatistics, pharmacokinetics (PK), bioanalysis, and medical writing solutions as the product candidate is evaluated in Alzheimer’s patients.

The purpose of the MAD study conducted at Altasciences’ Montréal clinical pharmacology unit, was to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions; to determine the maximum tolerated dose in healthy young and elderly study participants; and to allow Alzamend to proceed to the next step: dosing in planned subsequent Phase IIa clinical trials involving Alzheimer’s, bipolar disorder, major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) subjects.

“Our Phase I study was successfully conducted with Altasciences and we are excited to continue this partnership with our Phase IIa MAD study,” said Stephan Jackman, CEO of Alzamend. “We strongly believe that AL001’s patented ionic cocrystal technology may constitute a means of treating over 40 million Americans suffering from Alzheimer’s, bipolar disorder, MDD, and PTSD. We look forward to reporting topline data in June 2023 and further advancing clinical development of this promising potential therapeutic.”

The clinical and PK data generated during the clinical portion of the MAD study are undergoing evaluation by Altasciences to characterize the safety and drug exposure in healthy subjects, as well as Alzheimer’s patients.

“Altasciences’ mission is to help sponsors bring promising novel treatments, like AL001, to the people who need them, faster,” said Marie-Hélène Raigneau, co-chief operating officer. “Our team takes immense pride in the role we play to help improve lives through drug development and is delighted to continue our valued partnership with Alzamend.”

Altasciences has experience with early phase drug development, supporting sponsors with an end-to-end solution, from preclinical studies to clinical proof of concept, and beyond.