The CRO Altasciences announced that it worked with Alzamend Neuro to complete the clinical portion of a Phase IIa trial of AL001 in healthy subjects.
On March 22, Alzamend reported that it completed the clinical portion of a Phase IIa trial (NCT05363293) testing AL001 in both healthy subjects and patients with Alzheimer’s disease. On April 18, the CRO Altasciences announced that it had worked with Alzamend to complete the Phase IIa clinical portion in healthy subjects, and was continuing to provide clinical support as AL001 is evaluated in patients with Alzheimer’s disease.
Altasciences is evaluating results from the trial, and topline data is expected in June 2023.
AL001 is an oral treatment that is lithium-salicylate-L-proline engineered ionic cocrystal. According to Alzamend, it can deliver the benefits of marketed lithium carbonate, which is approved for bipolar disorder, while mitigating toxicities associated with lithium.
In each of the multiple healthy young and elderly and Alzheimer’s cohorts, consisting of six active and two placebo patients each, multiple ascending doses were administered three times daily for 14 days. The target lithium dose for Alzheimer’s treatment is expected to be at a level that will not require therapeutic drug monitoring.
Alazmend’s other pipeline product, ALZN002, is a patented method using a mutant peptide sensitised cell as a cell-based therapeutic vaccine which seeks to restore the ability of the patient’s immunological system to combat Alzheimer’s Disease. The company received go-ahead from the U.S. Food and Drug Administration (FDA) in October 2022 for Phase I/IIa clinical trial that began in March 2023.
“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, Chief Executive Officer 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.”