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2023-03-06| Trials & Approvals

Praxis Stock Hits All-Time Low After Phase 2 Tremor Data Released

by Reed Slater
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After announcing results from its Phase 2 study evaluating the safety and efficacy of ulixacaltamide to treat essential tremor (ET), Praxis Precision Medicines’ stock sunk to the lowest its ever been due to the less-than-stellar results. Despite missing statistical significance in the primary endpoint and clearly not impressing shareholders, Praxis says it plans to initiate Phase 3 trials for the drug in the second half of this year. 

ET and Praxis’ Efforts So Far

Affecting about seven million Americans each year, with 2 million diagnosed, ET is the most common movement disorder. ET can cause involuntary movement in the upper limbs, disrupting daily living. The disorder is progressive and can worsen over time. 

Ulixacaltamide is a small molecule that Praxis designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit related to ET. The company is also developing ulixacaltamide to treat Parkinson’s Disease.

Praxis recently announced results from its Essential1 study, which evaluated the safety and efficacy of ulixacaltamide in 132 ET patients. The study did not meet its primary endpoint of demonstrating improvement in modified activities of daily living (mADL) from baseline to day 56 compared to placebo. 

Even with the disappointing results in the primary endpoint, Praxis seems to be hanging its hat on secondary endpoints, including statistically significant improvements in the Clinical Global Impression-Severity (CGI-S) and Patient Global Impression-Change (PGI-C) scores. 

Related Article: Reata’s Groundbreaking Therapy for an Ultra-rare Neuromuscular Disease Secures FDA Approval

Praxis’ Ambitions Going Forward

After publishing the Essential1 study’s results, Praxis’ stock plummeted to less than one dollar on Friday, the lowest ever since the company went public in October 2020. Despite the study’s results and shareholders’ reactions, Praxis appears to be forging ahead in ulixacaltamide’s development. 

Marcio Souza, president and CEO of Praxis said, “The results from Essential1 illustrate the clear potential of ulixacaltamide as an effective and well-tolerated treatment for people with essential tremor. The study showed meaningful improvement in patient’s daily functioning, while also providing insights to guide the program’s advancement to Phase 3, including a deeper understanding of endpoints and trial design.”

With some tenacity and determination, Praxis plans to meet with the FDA to discuss the end of the Phase 2 trials and the beginning of Phase 3 trials. If all goes to plan, the company will initiate Phase 3 trials for ulixacaltamide to treat ET in 2023’s second half. 

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