Alzamend Neuro Inc ALZN received the FDA's "Study May Proceed" letter to initiate study AL001-BD01, a Phase 2A clinical study of AL001 for bipolar disorder type 1.
The company expects the first patient to be dosed in the first quarter of 2024
As a follow-up to our "IND submission" release in August, the FDA has granted us a "Study May Proceed" notification. Therefore, trial is expected to start in Q1. Data from previous Phase I and Phase 2A for AL001 will allow this trial to begin in Phase 2 rather than in Phase 1, the company told Benzinga.
This will be the 2nd "indication" for AL001. We began clinical trials for the indication of Alzheimer's Disease, and we expect to submit two more INDs by the end of 2023 for AL001…Major Depressive Disorder and PTSD, the company told Benzinga.
"If we are able to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the 7 million Americans who have bipolar disorder, said Stephan Jackman, Chief Executive Officer of Alzamend.
The company says Alzamend's recently completed Phase IIA study of AL001 in Alzheimer's patients and healthy subjects identified a candidate dose unlikely to require therapeutic drug monitoring.
Safety aspects of AL001 development may qualify for a Section (505)(b)(2) NDA pathway in support of FDA approval.
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