Praxis Precision Medicines Announces Upcoming Ulixacaltamide Presentations & Events
Praxis Precision Medicines (NASDAQ: PRAX) has scheduled an end-of-phase 2 meeting with the FDA for ulixacaltamide, aimed at treating Essential Tremor (ET), in June 2023. The company will also present key findings from its Essential1 trial at various medical conferences, including the 75th Annual AAN on April 23, 2023, and the World Congress on Parkinson’s Disease on May 15, 2023. Ulixacaltamide is a selective T-type calcium channel blocker designed to mitigate tremor activity, a common neurological disorder affecting roughly seven million people in the U.S. The current pharmacotherapy options are limited, underscoring the need for effective treatments, which may position ulixacaltamide favorably in the market.
- Scheduled FDA meeting to discuss ulixacaltamide development strategy.
- Presentations at major medical conferences to highlight Essential1 trial results.
- Ulixacaltamide targets significant unmet need in treatment for Essential Tremor.
- None.
Ulixacaltamide essential tremor end-of-phase 2 meeting with FDA scheduled for June 2023
BOSTON, April 17, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the following upcoming ulixacaltamide presentations and events focused on Essential Tremor (ET):
Medical Conference Presentations
- 75th Annual American Academy of Neurology (AAN), Boston, MA
- Summary: Industry talk presenting Essential1 topline results
- Title: Ulixacaltamide Essential1 ET Topline Results
- Date/Time: Sunday, April 23, 2023 at 1:00 p.m. EDT (Emerging Neurologic Care Presentation Stage in the Exhibit Hall)
- World Congress on Parkinson’s Disease and Related Disorders 2023 (IAPRD), Chicago, IL
- Summary: Poster presenting Essential1 topline results
- Title: Essential1: Results from a Phase 2 Trial Evaluating the Tolerability, Safety and Efficacy of Ulixacaltamide in Adults with Essential Tremor
- Date/Time: Monday, May 15, 2023 at 12:15 p.m. CT
- 2nd International Tremor Conference (ITC), New York, NY
- Summary: Essential1 results presentation and scientific talk
- Title: Essential 1: Results from a Phase 2 Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Clinical Trial to Evaluate the Tolerability, Safety, and Efficacy of Ulixacaltamide in the Treatment of Adults with Essential Tremor
- Date/Time: Thursday, May 18, 2023 at 4:20 p.m. EDT
Company Events
- Ulixacaltamide End-of-Phase 2 Meeting
- Summary: Meeting with U.S. Food and Drug Administration (FDA) to gain alignment on the overall development program and receive feedback on the Phase 3 clinical strategy to support a marketing application for ulixacaltamide
- Date/Time: June 2023
- Essential1 Results & Key Opinion Leader (KOL) Event
- Summary: Company hosted event to discuss full Essential1 results and provide insights into ulixacaltamide Phase 3 program with participation from ET KOLS
- Date/Time: June 2023 (additional details to follow)
The company hosted event will be available via live webcast through the Events & Presentations page of the Investors + Media section of the company’s website at www.praxismedicines.com. A replay of the webcast will be available on Praxis’ website for 90 days following the event.
About Ulixacaltamide
Ulixacaltamide is a differentiated and highly selective small molecule inhibitor of T-type calcium channels designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity. Ulixacaltamide, the most advanced program within Praxis’ Cerebrum™ small molecule platform, is currently in development for the treatment of essential tremor and as a non-dopaminergic treatment for the motor symptoms of Parkinson’s disease.
About Essential Tremor
Essential Tremor (ET) is the most common movement disorder, affecting roughly seven million people in the United States alone, including approximately two million diagnosed patients. ET is characterized by involuntary rhythmic movement in the upper limbs, with or without tremor in other body locations such as the head, vocal cords, or legs. These tremors significantly disrupt daily living and are progressive in nature, with increases in tremor severity and amplitude commonly observed over the course of the disease. There is only one approved pharmacotherapy for ET, propranolol, a beta blocker approved by the FDA in 1967, that offers limited efficacy and poor tolerability and is contraindicated for comorbidities that affect a significant share of the ET population. Other beta blockers and anti-convulsants are used off-label, though similarly are characterized by limited efficacy and tolerability. For these reasons, approximately
About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain. Praxis has established a diversified, multimodal CNS portfolio including multiple programs across movement disorders and epilepsy, with four clinical-stage product candidates. For more information, please visit www.praxismedicines.com and follow us on LinkedIn and Twitter.
FAQ
What is the purpose of the FDA meeting scheduled for June 2023 for PRAX?
When and where will the topline results of the Essential1 trial be presented by PRAX?
What is ulixacaltamide and its significance for Essential Tremor patients?
How many people in the U.S. are affected by Essential Tremor according to PRAX?
