Shares of Praxis Precision Medicines dropped 48% Friday morning following mixed Phase II results for ulixacaltamide (PRAX-944), its candidate being studied in movement disorder essential tremor.
Photo of man with tremors eating soup/Getty Images
Shares of Praxis Precision Medicines dropped 48% Friday morning following mixed Phase II results for ulixacaltamide (PRAX-944), which is being studied as a treatment for essential tremor (ET).
Data from the Essential1 trial showed that after 56 days, patients treated with ulixacaltamide had some improvement in modified Activities of Daily Living (mADL), the study’s primary endpoint. Still, that benefit did not reach statistical significance, causing the candidate to fall short.
PRAX-944 did meet specific secondary endpoints, including significant improvement in the patients’ TETRAS-ADL, Clinical Global Impression-Severity (CGI-S) and Patient Global Impression-Change (PGI-C) scores.
The trial tested the effect of daily treatment with ulixacaltamide at 60 or 100 mg in 132 patients.
Marcio Souza, CEO of Praxis, stated in the press release that based on the data, it’s clear to his team that ADLs are the preferred endpoint for a study in essential tremors. Though results were not as positive as the company had hoped, he said the candidate’s potential is clear.
ET is the most common movement disorder, affecting approximately 7 million people in the U.S. Despite this; there is only one treatment on the market for the disorder– propranolol, a beta blocker approved by the FDA in 1967.
Due to the treatment’s low efficacy and tolerability, roughly 40% of patients who seek pharmacotherapy treatment stop said treatment within two years.
Praxis plans to meet with the FDA to discuss the study findings and move the candidate into a Phase III trial in the second half of 2023.
