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Alzamend Neuro, Inc. reports clinical-stage biopharmaceutical developments for therapies aimed at Alzheimer's disease, bipolar disorder, major depressive disorder and post-traumatic stress disorder. Its pipeline centers on AL001, a patented ionic cocrystal formulation that delivers lithium with salicylate and L-proline, and ALZN002, a cell-based therapeutic vaccine approach designed to target Alzheimer's beta-amyloid.
Recurring news includes Phase II “Lithium in Brain” clinical study updates, brain and blood lithium pharmacokinetic and pharmacodynamic data, research activity with Massachusetts General Hospital, scientific presentations, annual financial results and financing actions supporting the company's clinical programs.
Alzamend Neuro has confirmed positive results from its Phase 1 trial of AL001, a lithium-delivery system intended for Alzheimer's treatment. The data demonstrate that AL001 is bioequivalent to marketed lithium carbonate, with a significantly lower dosage and similar plasma concentration curves. No serious adverse events occurred, indicating a favorable safety profile. With over 40 million Americans affected by related conditions, AL001 may reduce the need for lithium monitoring and provide a safer alternative. The company plans to initiate a Phase 2 study in Alzheimer's patients soon.
Alzamend Neuro has reported positive topline results from its Phase 1 clinical trial for AL001, a lithium delivery system aimed at treating Alzheimer's disease. The trial demonstrated that AL001 is bioequivalent to marketed lithium carbonate, suggesting the potential for effective treatment at lower doses. AL001's safety profile is benign with no significant adverse effects noted. The company plans to initiate a Phase 2 trial and pursue regulatory applications for several psychiatric disorders within the year, addressing a critical public health need.
Alzamend Neuro, Inc. (Nasdaq: ALZN) recently announced that the topline data for its Phase 1 clinical trial of AL001, aimed at treating dementia related to Alzheimer’s, will be released in mid- to late-December 2021. The company aims to utilize these results to swiftly transition into a Phase 2 study in early 2022. In addition, the FDA has agreed to a combined Phase 1/2 clinical study for AL002, a cell-based vaccine aimed at Alzheimer's, with an IND submission planned for Q2 2022. The positive FDA feedback is a significant step for Alzamend in its development of innovative therapies for neurodegenerative diseases.
Ault Global Holdings (NYSE American: DPW) reported significant financial results for the nine months ending September 30, 2021. Revenue increased by 167% to $44.6 million, bolstered by lending and trading activities, contributing $19.6 million. However, Q3 saw a revenue decline of $36.5 million, totaling negative $30.8 million, mainly due to unrealized losses in investments, particularly a $33.4 million loss from Alzamend Neuro (Nasdaq: ALZN). Despite a net income of $1.3 million for nine months, Q3 net loss was $42.9 million.
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Alzamend Neuro has received FDA approval to proceed with a combined Phase 1 and 2 clinical trial for its Alzheimer’s treatment AL002. The therapy aims to utilize a mutant-peptide sensitized cell to enhance the immune system's ability to combat Alzheimer’s by reducing beta-amyloid plaques. Alzamend intends to file its IND application by the end of November 2021 and begin the clinical trial in early 2022, based on positive preclinical results and feedback from the FDA.
Alzamend Neuro has achieved a significant milestone by dosing the first group of participants in a six-month Phase I comparative study for AL001, aimed at treating dementia related to Alzheimer's disease. This study will assess the safety and pharmacokinetics of AL001 compared to conventional lithium treatments, involving at least 24 healthy participants. The company believes AL001 could offer significant improvements over existing therapies for the over 40 million Americans suffering from Alzheimer's.
Alzamend Neuro, Inc. (Nasdaq: ALZN) announced a partnership with Altasciences to conduct a six-month Phase I clinical study for AL001, aimed at treating dementia related to Alzheimer’s disease. The study, commencing in September 2021, will evaluate the pharmacokinetics of AL001 compared to a marketed lithium carbonate capsule. AL001 utilizes patented ionic cocrystal technology designed to enhance lithium delivery. Alzamend believes this formulation may significantly improve treatment options for Alzheimer’s and other neurodegenerative diseases, reducing potential regulatory burdens.
Alzamend Neuro, Inc. (Nasdaq: ALZN) announced an additional investment from Digital Power Lending, LLC, totaling $2 million for 1,333,333 shares at $1.50 each. This funding follows the FDA's approval for a Phase 1a study of AL001, a lithium-based therapy for Alzheimer's-related dementia. As part of a March 2021 agreement, further capital will be provided based on future milestones. CEO Stephan Jackman expressed gratitude for the support, indicating that the funding positions Alzamend well for advancing clinical trials without needing new capital.
Alzamend Neuro (Nasdaq: ALZN) has submitted a pre-IND meeting request to the FDA for AL002, a cell-based therapeutic vaccine aimed at combating Alzheimer’s by restoring the immune system's ability to fight the disease. Recent toxicology results have been positive, leading to plans for a Phase 1 clinical trial at Emory University School of Medicine to assess the treatment's safety and efficacy. This trial will enroll patients with early-stage Alzheimer’s for a year, including an interim statistical analysis after six months.