Ferrous Sulfate/Ascorbic Acid

MELBOURNE, Australia and SAN FRANCISCO, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced promising new data related to ATH434 was presented at the Society for Neuroscience that took place November 11-15, 2023, in Washington, D.C. The poster entitled, “Potent Antioxidant and Mitochondrial-protectant Effects of ATH434, a Novel Inhibitor of α-Synuclein Aggregation with Moderate Iron-binding Affinity,” presents new data indicating that ATH434 can preserve mitochondrial function after oxidative injury and exert direct anti-oxidant activity independent of its iron binding properties. These features were not observed with another iron binding agent approved for treating iron overload that was also investigated. The study was run under the direction of Dr. Daniel J. Kosman, Distinguished Professor of Biochemistry at the State University of New York at Buffalo. David Stamler, M.D., Chief Executive Officer of Alterity, commented, “These exciting new data underscore the potential of ATH434 as a treatment for neurodegenerative diseases, including Parkinson’s disease and related disorders. We have long known that ATH434 is able to reduce labile iron which, when elevated, can drive oxidative stress. The demonstrated mitochondrial protection may reveal additional mechanisms that augment its ability to slow disease progression. We are grateful for the valued contributions from our collaborators in Dr. Kosman’s laboratory at SUNY-Buffalo.” The study, authored by Dr. Danielle Bailey, investigated the efficacy of ATH434 and comparator agents as mitochondrial protectants using a menadione-induced model of oxidative stress in a neuronal cell line. A suite of in-solution assays detailed the mechanisms underlying ATH434’s direct antioxidant capacity. The poster presentation can be accessed on Alterity’s website under The Science page. About ATH434 Alterity’s lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson’s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in two clinical trials: Study ATH434-201 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA and Study ATH434-202 is an open-label Phase 2 Biomarker trial in patients with more advanced MSA. ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission. About Alterity Therapeutics Limited Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s web site at www.alteritytherapeutics.com. Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: AustraliaHannah Howlettwe-aualteritytherapeutics@we-worldwide.com+61 450 648 064 U.S.Remy Bernardaremy.bernarda@iradvisory.com +1 (415) 203-6386 Forward Looking Statements This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the Company’s filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Pivotal trial will evaluate the effect of RBT-1 as a preconditioning agent in people undergoing cardiothoracic surgeryEstimated 600K CABG and valve repair surgeries in US/year, creating a large initial market for RBT-1PROTECT enrollment on track, NDA filing anticipated early 2026 SOUTHLAKE, Texas, Oct. 25, 2023 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal and metabolic diseases, today announced that the first patient has been dosed in the pivotal Phase 3 PROTECT trial of RBT-1, the Company's first-in-a-new-class preconditioning agent under investigation to reduce post-operative complications following cardiothoracic surgery. PROTECT is expected to be conducted at approximately 35 sites in the United States and Canada. Continue Reading Post-operative complications from cardiothoracic surgery represent a major unmet medical need. In the United States (US), there are approximately 600,000 CABG, valve repair, and related procedures conducted annually, with 66% of patients having complications that result in $6.5 billion in unnecessary healthcare costs. This represents a significant and growing initial market for RBT-1, which if approved, would be the first and only approved pharmacological therapy to reduce the risk of post operative complications following cardiothoracic surgery. RBT-1 (stannic protoporfin/iron sucrose), a fixed dose combination product given once intravenously over 1-2 hours, 24-48 hours before surgery, is a potent inducer of anti-inflammatory, antioxidant and iron-scavenging pathways. In a completed Phase 2 study, RBT-1 demonstrated statistically significant positive data in primary and several secondary endpoints, with reduced time in the ICU, shortened patient recovery time and fewer hospital readmissions. "We are pleased to initiate our PROTECT Phase 3 study of RBT-1. This milestone represents a significant step towards addressing the unmet needs associated with post-operative complications after cardiothoracic surgery, and underscores our commitment to transforming this treatment landscape," said Frank Stonebanks, Co-CEO of Renibus. "With our pivotal trial now underway in our PROTECT program, we are considering ways to expand the opportunity with RBT-1 across a wide spectrum of procedures and post-operative complications, including potentially transplant surgeries, TAVR's (trans aortic valve replacements) and thoracic aortic aneurysms. We believe that RBT-1 has broad "pipeline-in-a-product" potential, and we look forward to executing well in Phase 3 and bringing our product to patients in need." PROTECT is a Phase 3, Rand omized, Double-Blind, Placebo-Controlled S tudy to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complica tions in Subjects Undergoing Cardiac Surgery. The study is a randomized, double-blind, multi-center, placebo-controlled trial evaluating the effect of RBT-1 in approximately 400 patients. The primary endpoint is a severity-based composite hierarchy using the Win-Ratio or Finkelstein-Schoenfeld Method that includes the following: death, AKI requiring dialysis, ICU days, and 30-day cardiopulmonary readmission rates. Secondary and exploratory objectives include time on the ventilator, need for blood products, new onset atrial fibrillation, delirium, hospital length of stay, cost effective analyses and safety. Top line results are expected mid-2025. Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, added, "The cardiac surgery community is grateful for Renibus' commitment to bringing a new treatment option forward for patients undergoing cardiac surgery. RBT-1 is a potentially transformational pre-conditioning product, and I am enthusiastic about the initial results demonstrated in our patients." About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory, antioxidant and iron-scavenging pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardiorenal and metabolic diseases. Renibus' first-in-class lead program is RBT-1, currently being evaluated in a pivotal Phase 3 PROTECT study. RBT-3 is a novel, low molecular weight iron nanoparticle that has the potential to rapidly resolve iron deficiency and may reduce the risk of cisplatin-induced nephrotoxicity. RBT-9 (stannic protoporfin) is a potent anti-inflammatory and antioxidant drug with broad spectrum anti-viral properties. It has been investigated in a 42-patient Phase 2, randomized, placebo-controlled trial in high-risk patients with COVID-19. The data from this trial indicated the RBT-9 has the potential to significantly improve clinical outcomes in life threatening viral infections. Additional pre-clinical work is underway to help inform the clinical development strategy. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Frank Stonebanks Co-CEO, Renibus [email protected] SOURCE Renibus Therapeutics