Lithium carbonate

MARLBOROUGH, Mass.--( BUSINESS WIRE )-- TheracosBio today announced that, in the wake of the federal government release of negotiated prices under the Medicare Drug Price Negotiation Program, BRENZAVVY® (bexagliflozin) remains the lowest priced sodium-glucose cotransporter 2 (SGLT2) as compared to the Negotiated Monthly List Price, also referred to as the Maximum Fair Price, for other drugs in the SGLT2 class. “ While we salute the work that the federal government is doing to reduce the cost of pharmaceuticals, including important therapies for people on Medicare with type 2 diabetes, the sad fact remains that, even at sharply reduced prices for the leading brands in the class, the majority of people who might benefit from the addition of an SGLT2 will remain financially unable to start and stay on therapy ,” said Brian Connelly, President and CEO of TheracosBio. “ TheracosBio, since its founding, has been committed to addressing such financial barriers traditionally associated with pharmaceutical therapy in common, chronic diseases like type 2 diabetes ,” Mr. Connelly added. In the United States, BRENZAVVY is sold at a low cash-pay price, usually $50 or less, through a network of online and independent pharmacies. As patients prescribed BRENZAVVY are often uninsured, underinsured, or on Medicare, this lowest-in-class price point makes SGLT2 therapy affordable for a larger number of people who might otherwise not be able to start and stay on therapy. For healthcare professionals, BRENZAVVY can easily be prescribed without insurance plan hurdles that the SGLT2 class traditionally faces, such as prior authorizations. BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Phase 3 clinical studies have shown BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors or combinations of these drugs. BRENZAVVY is available as 20 mg oral tablets recommended to be taken once daily, in the morning with or without food. BRENZAVVY is contraindicated in patients who are hypersensitive to bexagliflozin or any other ingredient in the BRENZAVVY tablet. The most common side effects of taking BRENZAVVY include female genital mycotic infections, urinary tract infections, and changes in urination, but more serious side effects are possible (see below, Important Safety Information about BRENZAVVY). BRENZAVVY treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL/min/1.73 m 2 . Patients with eGFR between 30 and 59 mL/min/1.73 m 2 are said to be in stage 3 chronic kidney disease. BRENZAVVY was the first SGLT2 inhibitor shown in a randomized, controlled clinical trial to be effective for glycemic control in adults with type 2 diabetes and stage 3 (3a + 3b) chronic kidney disease. To learn more about BRENZAVVY and for full prescribing information visit https://www.brenzavvy.com . To report suspected adverse reactions, contact TheracosBio at 1-855-BRENZAVVY (1-855-273-6928) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Important Safety Information about BRENZAVVY Limitation of Use: BRENZAVVY (bexagliflozin) is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. Contraindications BRENZAVVY is contraindicated in patients with hypersensitivity to bexagliflozin or any excipient in BRENZAVVY. Anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (SGLT2) inhibitors. Warnings and Precautions Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis BRENZAVVY increases the risk of life-threatening ketoacidosis in patients with type 1 diabetes. Type 2 diabetes and pancreatic disorders are also risk factors for ketoacidosis and fatal events of ketoacidosis have been reported in patients with type 2 diabetes using SGLT2 inhibitors. Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse. Signs and symptoms of diabetic ketoacidosis are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Assess patients who present with signs and symptoms of metabolic ketoacidosis, regardless of blood glucose levels. If suspected, discontinue BRENZAVVY, treat promptly and monitor for resolution before restarting. Consider ketone monitoring in patients with type 1 diabetes mellitus as well as in others at risk for ketoacidosis. Withhold BRENZAVVY in clinical situations known to predispose to ketoacidosis and resume when clinically stable. Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue BRENZAVVY and seek medical attention immediately if signs and symptoms occur. Lower Limb Amputation Lower limb amputations have been observed in patients treated with BRENZAVVY in a study of patients with type 2 diabetes who had either established cardiovascular disease (CVD) or were at risk for CVD. Of the 23 BRENZAVVY-treated patients who had amputations, 15 were amputations of the toe and midfoot and 8 were amputations above and below the knee. Some patients had multiple amputations. Lower limb infections, gangrene, ischemia, and osteomyelitis were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy. Before initiating BRENZAVVY, consider factors in the patient’s history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Counsel patients receiving BRENZAVVY about the importance of routine preventative foot care and monitor for signs and symptoms of diabetic foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and institute appropriate treatment. Volume Depletion BRENZAVVY can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors. Before initiating, assess volume status and renal function in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients with low systolic blood pressure, or patients on loop diuretics. In patients with volume depletion, correct this condition. After initiating, monitor for signs and symptoms of volume depletion and renal function. Urosepsis and Pyelonephritis Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including BRENZAVVY. Treatment with BRENZAVVY increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat them promptly. Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Insulin and insulin secretagogues (e.g., sulfonylureas) are known to cause hypoglycemia. BRENZAVVY may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with BRENZAVVY. Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) Serious, life-threatening cases requiring urgent surgical intervention have been identified in postmarketing surveillance in both males and females with diabetes mellitus receiving SGLT2 inhibitors. Serious outcomes have included hospitalization, multiple surgeries, and death. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal areas, along with fever or malaise. If suspected, start treatment, and discontinue BRENZAVVY. Genital Mycotic Infections BRENZAVVY increases the risk of genital mycotic infections. Patients who have a history of genital mycotic infections or who are uncircumcised are more likely to develop genital mycotic infections. Monitor and treat appropriately. MOST COMMON ADVERSE REACTIONS (>5%): Female genital mycotic infections, urinary tract infection and increased urination. USE IN SPECIFIC POPULATIONS Pregnancy: BRENZAVVY is not recommended during the second and third trimesters. Lactation: BRENZAVVY is not recommended when breastfeeding. Geriatric patients: There is a higher incidence of adverse reactions related to volume depletion. Renal Impairment: There is a higher incidence of adverse reactions related to reduced renal function. Hepatic Impairment: BRENZAVVY is not recommended for patients with severe hepatic impairment. DRUG INTERACTIONS: Inducers of UGT1A9 could result in more rapid clearance of BRENZAVVY by metabolism. Doses of insulin and sulfonylureas may need to be reduced to offset the action of BRENZAVVY. The safety of BRENZAVVY is compromised when it is coupled with insulin or an insulin secretagogue (sulfonylureas and meglitinides – the latter rarely used in the US). Lithium carbonate is used as a mood stabilizer in bipolar disorder. Lithium ions might be preferentially (compared to sodium ions) taken up with glucose in the kidney. Empirical evidence has shown that lithium levels can be lower when SGLT2 inhibitors are administered. SGLT2 inhibitors produce pronounced glucosuria, which makes urine testing for glucose diagnostically useless. Measurements of 1,5 anhydroglucitol are also compromised. For additional important safety information about BRENZAVVY, please see the full Prescribing Information . About TheracosBio TheracosBio develops novel therapeutics for diseases with significant societal impact. The mission of TheracosBio is to expand access to new medications for patients with common diseases.

ATLANTA--( BUSINESS WIRE )-- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“ Alzamend ”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“ Alzheimer’s ”), bipolar disorder (“ BD ”), major depressive disorder (“ MDD ”) and post-traumatic stress disorder (“ PTSD ”), today shared a letter from its Chief Executive Officer, Stephan Jackman. Dear Stockholders, I am reaching out to share an update about our clinical programs and the outlook for the future. Planned Clinical Trials The heart of Alzamend’s mission lies in pioneering breakthroughs that have the potential to transform lives. I am thrilled to share that our planned clinical trials are currently on pace to make significant progress over the next year. The dedication of our research and development partners, in collaboration with experts in the field, has propelled us closer to potentially achieving significant milestones. AL001 Our lead therapeutic drug candidate, AL001, is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Our preclinical data for AL001 treatment showed prevention of cognitive deficits, depression and irritability in mice models, and has shown to be superior in improving associative learning, memory, and irritability, compared with lithium carbonate treatments. In March 2022, we announced that full data sets from our Phase I bioequivalent study affirmed that the extent of lithium absorption in plasma indicated that AL001 at 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product. In June 2023, we announced topline data from our Phase IIA multiple-ascending dose study in Alzheimer’s and healthy patients, which initiated in May 2022. Results from the Phase IIA study identified a maximum tolerated dose (“ MTD ”), as assessed by an independent safety review committee. This MTD, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily (“ TID ”), is designed to be unlikely to require therapeutic drug monitoring (“ TDM ”). Moreover, this dose is designed to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts and thereby avoiding clinical disadvantages. In the latter half of 2023, Alzamend submitted and received "Study May Proceed" letters from the United States Food and Drug Administration (“ FDA ”) encompassing three additional investigational new drug (“ IND ”) applications for AL001 in BD, MDD, and PTSD. Alzamend recently announced it reached a partnership agreement with Massachusetts General Hospital to serve as its contract research organization (“ CRO ”) in connection with five Phase II clinical trials, one for healthy human subjects, and one each in patients with Alzheimer’s, BD, MDD and PTSD. The clinical trials will be designed to determine relative increased lithium levels in the brain of AL001 compared to a marketed lithium salt. One of Alzamend’s goals is to replace a 300 mg TID lithium carbonate dose for treatment of BD with a 240 mg TID AL001 lithium equivalent, which represents a daily decrease of 20% of lithium given to a patient. Lithium is a commonly prescribed drug for manic episodes in BD type 1 as well as maintenance therapy of BD in patients with a history of a manic episode. Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option (considered the “gold standard”) and is utilized off-label for MDD and PTSD. Alzamend believes these programs may qualify for the 505(b)(2) pathway for FDA approval, which is available to new formulations of an approved drug. Alzamend anticipates initiating all five of these studies in the first half of 2025, with exact dates to be announced before the end of 2024. ALZN002 Our secondary therapeutic drug candidate, ALZN002, is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. The proposed mechanism of action is through the pulsed-Dendritic Cell (“DC”) activation of T-cells that stimulates the immune system, resulting in the clearance of brain amyloid. As people age, their immune systems may degrade, and some people may be unable to produce natural beta-amyloid antibodies, the absence of which leads to the plaque build-up causing Alzheimer’s. ALZN002 is intended to elicit an immune response to produce anti-amyloid antibodies, which can then neutralize circulated beta-amyloids and prevent additional plaque build-up. The goal of this treatment approach is to foster tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms. In April 2023, we announced the initiation of a Phase I/IIA clinical trial for ALZN002. The purpose of this trial is to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of placebo in 20-30 subjects with mild to moderate morbidity. In February 2024, we received notice from our CRO on the clinical trial that it was terminating our contract with them. We are currently pursuing the engagement of a replacement CRO and anticipate that the study will resume in the fourth quarter of 2024. Financial Condition In an ever-evolving industry, financial prudence remains a cornerstone of our strategic approach. Our disciplined cost management, prudent resource allocation, and strategic investments in high-potential areas have collectively contributed to our financial resilience. We believe that this approach not only fortifies our foundation but also preserves our ability to achieve growth in the years ahead. We raised capital through an at-the-market sales agreement in the fourth quarter of 2023 through the first quarter of 2024, which we strategically utilized from time to time with a goal of not disrupting the market. We also entered into two separate securities purchase agreements in 2024. The first one with an entity associated with our founder and largest stockholder, pursuant to which we have received $2.1 million in gross proceeds to date, and which the investor has the right to purchase up to an additional $3.9 million of securities through March 31, 2025. The second agreement with an outside investor, pursuant to which we have received $7.0 million in gross proceeds to date. Under the second agreement, the investor is obligated to purchase, subject to certain conditions, up to an additional $18.0 million of securities through January 2026. Please see our Securities and Exchange Commission filings for additional information regarding the securities purchase agreements described above and the terms of such financing transactions. We remain grateful for the support from our investors as we continue to apply those strategic investments to drive our anticipated future growth. Our strategic roadmap includes further optimizing operational efficiencies, expanding our footprint within the industry, and deepening our commitment to bringing our therapeutics to the market. As we progress through 2024 and into 2025, we look forward to sharing with you updates on our clinical progress. Nasdaq Compliance In April 2024, we announced that a Nasdaq Hearings Panel granted Alzamend’s request to continue its listing on The Nasdaq Capital Market (“ Nasdaq ”), subject to Alzamend demonstrating compliance, on or before September 23, 2024, with Listing Rule 5550(b)(1), which requires stockholder equity of at least $2.5 million (the “ Stockholder Equity Rule ”) and satisfying all applicable requirements for continued listing on Nasdaq. We believe that the capital raises from the securities purchase agreements described above will enable us to achieve compliance with the Stockholder Equity Rule within the timeframe required by Nasdaq. I want to express my sincere gratitude for your continued trust and support. I fully understand that the market has not been kind these past few years. Our stockholders play a pivotal role in our journey, and we remain dedicated to delivering long-term value through prudent fiscal management and pioneering advancements in biotechnology. We eagerly anticipate the opportunities that lie ahead and are confident in our ability to create lasting value for all stockholders. Sincerely, Stephan Jackman Chief Executive Officer, Alzamend Neuro About Alzamend Neuro Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com .