$4.510
-0.050 (-1.10%)At close
ATHE News
ATHE Events
Alterity Therapeutics Granted New Patent for ATH434
Alterity Therapeutics announced that the United States Patent and Trademark Office has granted a new composition of matter patent for ATH434, the company's lead clinical asset. ATH434 is an oral agent designed to treat the underlying pathology of neurodegenerative diseases such as Multiple System Atrophy, Parkinson's disease and related disorders. The newly granted patent represents a significant intellectual property milestone for Alterity and strengthens ATH434's long-term commercial potential as the Company prepares to initiate Phase 3 trial activities in MSA by year-end 2026.
Alterity Therapeutics Receives FDA Meeting Minutes Confirming ATH434 Phase 3 Trial
Alterity Therapeutics announced that it has received the official meeting minutes from its End-of Phase-2 meeting for ATH434 in Multiple System Atrophy from the FDA. The minutes confirm the elements of the registrational Phase 3 program previously announced on June 9 and the path toward a potential new drug application filing. The minutes confirmed that the FDA agreed with the proposed Phase 3 trial design, including the study population, treatment regimen, and efficacy endpoints. Alignment was reached on the selection and analysis of the primary endpoint - the 11-item UMSARS Part I1 rating scale, a functional measure of activities of daily living affected in MSA. Agreement was also reached on selection of key secondary endpoints, including the Swallowing Disturbance Questionnaire, the Orthostatic Hypotension Symptom Assessment and the Clinical Global Impression of Severity. The Phase 3 study is expected to enroll approximately 200 patients who will be randomized in a 1:1 ratio and treated with ATH434 50 mg or matching placebo twice daily for 12 months. The FDA further indicated that a single pivotal trial plus confirmatory evidence could provide the necessary data to support an approval of ATH434 for the treatment of MSA. Alterity expects that the data from its ATH434-201 Phase 2 clinical trial will provide the required confirmatory evidence. The FDA also indicated that the anticipated size of Alterity's safety database at the conclusion for the Phase 3 was reasonable. A single pivotal trial provides an efficient route to completion of the clinical development program and potential filing of an NDA, both in time and resources required. The company also plans to offer an open label extension to participants who complete the Phase 3 trial to continue their treatment and enhance the safety database for ATH434.
Alterity Therapeutics Publishes MSA Study Results
Alterity Therapeutics announced the publication of a peer-reviewed study in NeuroImage, demonstrating that quantitative susceptibility mapping MRI can detect disease-specific iron accumulation in the brains of patients with Multiple System Atrophy, distinguish MSA from Parkinson's disease, and track clinical disease severity - including in early-stage disease. MSA patients showed significantly higher iron content in the lentiform nucleus - comprising the globus pallidus and putamen - versus both healthy controls and PD, with the most pronounced effect in the globus pallidus. Iron content in the globus pallidus distinguished MSA from PD with moderate-to-good accuracy, with comparable performance in the early-stage subgroup - a setting in which clinical misdiagnosis is common. Higher iron content was significantly correlated with greater overall disease severity on the Unified Multiple System Atrophy Rating Scale, linking the imaging measure directly to patients' functional and motor impairment. In preliminary 12-month analyses of the early-stage bioMUSE cohort, both the magnitude and spatial extent of abnormal iron accumulation increased progressively, paralleling clinical decline. Alterity remains on track to hold its End-of-Phase 2 meeting with the FDA in mid-2026, the next key step toward initiation of a pivotal Phase 3 trial in MSA.
Alterity Therapeutics Receives FDA Feedback, Advances ATH434 Phase 3 Development
Alterity Therapeutics announced it has received regulatory feedback following a Type C meeting with the FDA regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy. This second Type C Meeting builds on Alterity's recent regulatory interactions with the FDA and represents a further step for the planned Phase 3 trial in MSA. Alterity received written feedback supporting its plans related to the chemistry, manufacturing, and control elements of the program. The first Type C meeting, which was announced in March, related to clinical pharmacology and non-clinical development aspects of the program. "Confirming alignment with the FDA on the chemistry and manufacturing of ATH434 represents another critical step toward initiation of our Phase 3 program," said David Stamler, CEO of Alterity. "The FDA endorsed our plans related to the manufacture and testing of ATH434 for use in our Phase 3 trial and ultimately for commercialization, if approved. We continue to advance ATH434 through the necessary steps to initiate our pivotal development program, and we look forward to finalizing our plans with the FDA at an End-of-Phase 2 meeting that remains on track for mid-year 2026."
Alterity Therapeutics Presents ATH434 Clinical Data
Alterity Therapeutics announced the presentation of new data analyses from the Phase 2 trial of ATH434, demonstrating clinical efficacy in patients with Multiple System Atrophy. The analysis was delivered in an oral presentation during a Late Breaking Science Session at the American Academy of Neurology annual meeting taking place in Chicago. The presentation, entitled, "ATH434 Demonstrates Disease-Modifying Signal in Multiple System Atrophy Using the MuSyCA Composite Scale," described an analysis from the ATH434-201 Phase 2 clinical trial in MSA utilizing the MSA Combined Outcome Assessment. The MuSyCA is a newly developed scale that includes 11 items from both the UMSARS1 I and UMSARS II with highest standardized effect sizes across four MSA cohorts and is intended to improve detection of disease progression in clinical trials. Assessment of the ATH434-201 trial showed results utilizing MuSyCA. MuSyCA demonstrated sensitivity to disease progression with placebo participants worsening by approximately +9.7 points over 52 weeks, confirming the scale is sensitive to change over the study period. Consistent with prior data, ATH434 slowed disease progression on the MuSyCA assessment with a treatment effect of -1.9 to -4.0 points at Week 52. In contrast, when utilizing a MMRM3 statistical analysis, ATH434 slowed disease progression on the modified UMSARS I versus placebo by -3.1 points at 75 mg and -4.7 points at 50 mg.
This page is for research only and is not investment advice. Models can be wrong. Past performance does not guarantee future results.