1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Praxis Pushes Ulixacaltamide Into Phase III For Essential Tremor, But Uncertainty Remains

 
• By Alaric DeArment

Praxis hopes to initiate a Phase III later in 2023, but an analyst said it is unclear if regulators will align with the company on a proposed primary endpoint.

Praxis announced results from its Phase II study in essential tremor • Source: Shutterstock

Praxis Precision Medicines, Inc. plans to move ulixacaltamide for essential tremor into Phase III development after announcing mixed results from the Phase IIb Essential1 trial, meaning it has found some success in shifting its R&D focus after a study of its drug for depression failed in 2022. But some uncertainty remains about the proposed primary endpoint for the ulixacaltamide Phase III trial based on its communication with US regulators.

The company said 3 March that the results of Essential1 showed a numerical improvement in the primary endpoint of modified...

More from Clinical Trials

Actuate Is Looking For A Buyer To Advance Pancreatic Cancer Candidate

 
• By Jessica Merrill

After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.

In Brief: Kezar Plots Lupus Revival For Zetomipzomib As FDA Lifts Hold On Hepatitis Trial

 
• By Manas Mishra

The go-ahead to resume a trial for its only drug candidate, zetomipzomib, in hepatitis could give Kezar a glimmer of hope of reviving another halted study in lupus nephritis.

AstraZeneca’s Amyloidosis Drug Fails In Phase III But Subgroup Hopes Persist

 
• By Andrew McConaghie

Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.

PureTech Ponders Way Forward As CEO Exits

 
• By Kevin Grogan

Bharatt Chowrira departs days after firm’s chair stepped down.

More from R&D

Kailera Eyes Global Obesity Market With Hengrui’s Phase III Dual Agonist

 
• By Joseph Haas

With China’s Hengrui reporting successful Phase III data for its dual GLP-1/GIP agonist, licensee Kailera is readying plans to demonstrate better efficacy than current obesity drugs.

Sellas Targets Tambiciclib To Adverse-Risk Frontline AML Patients After Phase II Success

 
• By Alaric DeArment

The biotech announced positive Phase II data for the drug combined with AbbVie/Roche’s Venclexta and BMS’s Vidaza in relapsed/refractory acute myeloid leukemia.

China’s Mid-Cap Companies Thriving On Big Pharma Deals

 
• By Andrew McConaghie and Edwin Elmhirst

Big pharma is increasingly looking east to restock its pipelines, a process that is helping to forge a new generation of mid-sized R&D-based companies in China and is reflected in their stock price performance.