Adeona Pharmaceuticals, a developer of synthetic DNA-based therapeutics, has commenced the Phase II clinical trial of its Trimesta drug, designed to treat cognitive dysfunction in multiple sclerosis (MS).
Trimesta, an oral estriol, is used for treating relapsing-remitting MS and for cognitive dysfunction in MS, both in female patients, and has been approved throughout Europe and Asia as a treatment for post-menopausal symptoms.
The randomised double-blind placebo-controlled Phase II trial will enroll 64 relapsing-remitting or secondary-progressive female MS patients at the University of California, Los Angeles (UCLA). The primary objective of the study is the average change in Paced Auditory Serial Addition Test (PASAT) scores at 12 months between each group, while secondary outcome measures include relapse rates, whole brain atrophy determined by MRI and safety.
Principal investigator of the study Rhonda Voskuhl said statistics show that 50-65% of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. "The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working," she added.
The study is based on findings from a previously completed ten-patient single-agent crossover Phase I/II clinical trial that demonstrated a considerable 14% improvement from baseline in PASAT cognitive testing scores in relapsing-remitting MS patients following six months of Trimesta therapy. PASAT is a measure of cognitive function that evaluates auditory information processing speed and flexibility, as well as calculation ability and is widely used in MS to measure cognitive function.
Another 15-centre Phase II randomised double-blind placebo-controlled clinical trial is also being conducted to assess Trimesta's ability to reduce relapse rates in women with the relapsing-remitting form of MS.
Adeona is a biotechnology company focused on the development of synthetic DNA-based therapeutics and innovative disease-modifying medicines for pulmonary arterial hypertension, relapses in multiple sclerosis, cognitive dysfunction in multiple sclerosis, fibromyalgia and amyotrophic lateral sclerosis (ALS).