The surge comes after the company that researches Alzheimer’s disease, bipolar disorder and depressive disorder announced a key alliance for the development of a study.
The actions of Alzamend Neuro soared Monday after the company announced it would begin a mid-stage study of its treatment for patients with post-traumatic stress disorder (PTSD). Shares of the Nasdaq-listed firm rose +460%, moderating the rise, having reached +600% as soon as the market opened.
The pharmaceutical company said it has partnered with Massachusetts General Hospital as its contract research organization to conduct a Phase 2 study of AL001, the company’s lithium therapeutic drug candidate. The goal of the new study is to identify a potentially ideal dose to achieve the same effectiveness and safety of AL001 compared to products currently on the market.
“Alzamend is optimistic that this study will help meet regulatory safety standards,” the company added.
Although lithium does not have a Food and Drug Administration (FDA) indication for PTSD, the company said that treatment with low doses of lithium carbonate has been reported to provide effective treatment for reducing inappropriate anger, irritability, anxiety and insomnia in these patients.
Details about Alzamend Neuro
Alzamend Neuro is a biopharmaceutical company focused on developing innovative products for the treatment of Alzheimer’s disease, bipolar disorder (BD), major depressive disorder (MDD), and PTSD. Massachusetts General Hospital is the original and largest clinical education and research facility of Harvard Medical School/Harvard University and is home to the largest hospital-based research program in the world.
Alzheimer’s
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Lithium was the first mood stabilizer approved by the FDA and remains a first-line treatment option (considered the “gold standard”) for TB. Furthermore, lithium has been on the market for over 35 years and its human toxicology is well characterized, which could mitigate the regulatory burden on safety data.
The aim of this new trial is to evaluate the comparative increase in lithium levels in the brain and its structures compared to a commercially available lithium salt in patients with PTSD.By examining the lithium content in patients’ brains and brain structures during treatments, Alzamend aims to predict the minimum dose needed to achieve the same effectiveness and safety of AL001 in contrast to established lithium salts..
Alzamend is optimistic that this study will help meet regulatory safety standards through the US FDA’s 505(b)(2) approval pathway, which is specifically designed for new formulations/delivery systems of an approved drug.
Source: Ambito
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