EXCLUSIVE: Alzamend Neuro Completes Clinical Portion Of Mid-Stage Alzheimer's Trial

  • Alzamend Neuro Inc ALZN announced it had completed the clinical portion of its Phase 2A multiple ascending dose (MAD) study of AL001 in subjects with dementia related to Alzheimer’s. 
  • This blinded, placebo-controlled trial (AL001-02) was initiated in May 2022 and is designed to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose in patients diagnosed with mild to moderate Alzheimer’s and healthy subjects.
  • Alzamend is also pursuing AL001 for bipolar disorder, major depressive disorder, and post-traumatic stress disorder. 
  • Related: Alzamend Neuro Seeks FDA Nod For Dementia Immunotherapy Study
  • AL001 is a novel lithium-salicylate-L-proline engineered ionic cocrystal lithium delivery system. 
  • “We strongly believe that AL001’s patented ionic cocrystal technology could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million American suffering from Alzheimer’s, bipolar disorder, MDD, and PTSD”, said Stephan Jackman, CEO of Alzamend. 
  • The company anticipates reporting topline data in June 2023.
  • Lithium has been well characterized for safety and is approved/marketed in multiple formulations for bipolar affective disorders. 
  • AL001 lithium ascending dosing for the MAD cohorts tested incremental fractions of the usual lithium exposure for the treatment of the bipolar affective disorder, with the target lithium dose for Alzheimer’s treatment expected at a level that will not require therapeutic drug monitoring.  
  • Price Action: ALZN shares closed +13.50% at $0.42 on Tuesday.
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