New research suggests that powerful magnets could effectively treat bipolar disorder. This therapy, which is known as accelerated intermittent theta burst stimulation (iTBS), uses magnetic waves targeted at specific brain regions and has shown promise in easing symptoms for patients with treatment-resistant bipolar disorder.1 Initially approved for major depressive disorder by the FDA, iTBS offers a non-drug option for bipolar patients who do not respond well to medications or struggle with their side effects. Other companies advancing treatments for bipolar disorder include Alzamend Neuro, Inc. (NASDAQ:ALZN) a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer’s disease, bipolar disorder, major depressive disorder, and PTSD, Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), Teva Pharmaceutical Industries Limited (NYSE:TEVA), and AbbVie Inc. (NYSE:ABBV) are other pharmaceutical companies working on innovative treatments for various mental health disorders.
Alzamend Neuro, Inc. (NASDAQ:ALZN) is focused on rapidly developing and marketing safe and effective treatments to bring aid to the over 43 million Americans and over 600 million people worldwide suffering from psychiatric illnesses.
Alzamend Neuro’s pipeline includes two innovative drug candidates: AL001 and ALZN002. AL001, a patented ionic cocrystal technology, safely delivers lithium by combining lithium, salicylate, and L-proline for the treatment of Alzheimer’s Disease, Bipolar Disorder, Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD). ALZN002 uses a patented method to restore the immune system’s ability to combat Alzheimer’s. AL001 aims to reduce the harmful side effects of traditional lithium therapy by ensuring safer distribution in the brain and eliminating the need for constant monitoring.
Alzamend Neuro, Inc. (NASDAQ:ALZN) is advancing treatments for mental health disorders, potentially accelerating clinical phase progress due to the success of AL001. In 2023, the company filed IND applications for Phase IIA Clinical Trials of AL001 for Bipolar Disorder, MDD, and Post-Traumatic Stress Disorder (PTSD). By the end of 2023, the FDA granted approval for these studies via “Study may proceed” letters.
On August 6th, Alzamend Neuro, Inc. (NASDAQ:ALZN) announced a partnership with Massachusetts General Hospital for a Phase II clinical trial of AL001, involving patients with bipolar disorder. Dr. Ovidiu Andronesi, MD, PhD, from Harvard University, will be the Principal Investigator. This trial will compare AL001’s bioavailability and distribution against a marketed lithium carbonate product in the human brain. Previous Phase I and Phase IIA studies showed a benign safety profile and identified a candidate dose unlikely to require therapeutic drug monitoring.
Lithium is commonly prescribed for manic episodes in bipolar disorder type 1, maintenance therapy, and off-label for MDD and PTSD. This trial aims to predict the minimum dose necessary to achieve the equivalent effectiveness and safety of AL001 compared to marketed lithium salts. Alzamend Neuro believes this program may fulfill regulatory safety requirements via a Section 505(b)(2) pathway for FDA approval, a process that uses pre-existing data and new findings to help expedite the approval process.
“We are elated to partner with Massachusetts General Hospital and Dr. Andronesi in this pivotal study for our lead therapeutic candidate AL001,” said Alzamend Neuro, Inc. (NASDAQ:ALZN) CEO Stephan Jackman, “If we can develop a next-generation lithium product (AL001) with an improved safety profile and enhanced biodistribution in the brain that would not routinely require therapeutic drug monitoring (“TDM”), it would constitute a major improvement over current lithium-based treatments and positively impact the 7+ million Americans afflicted with bipolar disorder. We look forward to providing more details regarding study timelines and market opportunity in the near future.”
Alzamend Neuro, Inc. (NASDAQ:ALZN) also announced a collaboration with Massachusetts General Hospital (MGH) to conduct a Phase II clinical trial for AL001 for the potential treatment of Alzheimer’s disease. This trial will involve both Alzheimer’s patients and healthy subjects to compare the bioavailability and brain distribution of AL001 versus a marketed lithium carbonate product. The trial, which will also be led by Dr. Ovidiu Andronesi of Harvard University, aim to establish AL001’s safe, effective, and tolerable dosing requirements.
Click here for more information about Alzamend Neuro, Inc. (NASDAQ:ALZN).
Pharma Advances: New Treatments for Bipolar Disorder, Depression, and Schizophrenia
In April 2024, Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) announced FDA approval of Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes in adults with bipolar I disorder. Fanapt, an atypical antipsychotic, has been used since 2009 for schizophrenia. This approval offers a new treatment option for bipolar I disorder, characterized by periods of mania and depression, affecting 2.8% of US adults. A pivotal study of 400 patients showed significant improvement in mania symptoms with Fanapt® over placebo by Week 4. Fanapt’s safety profile remains consistent with previous schizophrenia studies, offering flexible dosing and a well-known safety record.
In June, Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) announced positive topline results from Study 502, evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for major depressive disorder (MDD). Combined with the positive results from Phase 3 Study 501, these findings support their supplemental New Drug Application (sNDA) for the adjunctive treatment of MDD, expected to be submitted to the FDA in the second half of 2024. CAPLYTA® (lumateperone) is approved for adults to treat schizophrenia and depressive episodes linked with bipolar I or II disorder (bipolar depression), either alone or in combination with lithium or valproate.
Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Limited (NYSE:TEVA), announced on June 1 the presentation of seven studies at the Psych Congress Elevate 2024 Annual Meeting in Las Vegas, Nevada. These studies focus on their long-acting injectable (LAI) schizophrenia research program, including strategies for transitioning patients from a once-monthly intramuscular injection of Invega Sustenna to UZEDY, an extended-release injectable suspension of risperidone administered subcutaneously every one or two months for adults with schizophrenia.
AbbVie Inc. (NYSE:ABBV) and Gilgamesh Pharmaceuticals have partnered to develop next-generation therapies for psychiatric disorders, leveraging AbbVie’s psychiatry expertise and Gilgamesh’s innovative neuroplastogen research platform. These new compounds aim to offer clinical benefits for conditions like mood and anxiety disorders while minimizing psychoactive effects seen in traditional psychedelics. Gilgamesh’s research platform has successfully identified lead compounds in this novel therapeutic class. Under the agreement, AbbVie will lead development and commercialization efforts, with Gilgamesh receiving an upfront payment of $65 million and potential milestone payments totaling up to $1.95 billion, along with royalties on future sales.
As of July 18, Alzamend Neuro, Inc. (NASDAQ:ALZN) closed two tranches of a private placement of a $25 million purchasing agreement.
Click here for more information about Alzamend Neuro, Inc. (NASDAQ:ALZN).
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