Phase II study of Trimesta for relapsing-remitting multiple sclerosis yields positive efficacy and safety results


Synthetic Biologics reports that the University of California, Los Angeles (UCLA) School of Medicine (USA) has announced preliminary, positive top-line data from the phase II clinical trial evaluating Trimesta (oral estriol), an oral, once-daily treatment for relapsing-remitting multiple sclerosis in women. 

The phase II study, initiated and led by Rhonda Voskuhl, professor, Department of Neurology, Jack H Skirball chair in Multiple Sclerosis Research and director, Multiple Sclerosis Program at UCLA David Geffen School of Medicine, USA, demonstrated that Trimesta given with first-line relapsing-remitting multiple sclerosis therapy Copaxone (glatiramer acetate injection) resulted in reduced annualised relapse rate. It also yielded improved cognitive function at 12 months of treatment compared to placebo and Copaxone. Voskuhl presented the data at the 66th Annual Meeting of the American Academy of Neurology in Philadelphia, USA (26 April–3 May) as part of the Emerging Science Program.

Voskuhl comments: “Pregnancy is known to be a period of relative protection from multiple sclerosis relapses, and the therapeutic effects of pregnancy hormones, including estriol, include both anti-inflammatory and neuroprotective mechanisms as evidenced in animal models of the disease. We are encouraged by the top-line results from this first randomised placebo-controlled trial evaluating oral estriol due to the positive impact of adjunctive therapy with estriol on the patients in this study. We look forward to continued clinical evaluation of estriol, which we believe has the potential to slow disease progression and improve quality of life for women with relapse-remitting multiple sclerosis.”

The trial randomised 158 women with relapsing-remitting multiple sclerosis at 16 sites across the USA. Among the results, women receiving Trimesta plus Copaxone demonstrated a statistically significant 47% decrease in annualised multiple sclerosis relapse rate in the first 12 months of treatment as compared to women receiving placebo plus Copaxone. In addition, a significant improvement in cognitive function was observed at 12 months as measured by Paced Auditory Serial Addition Test (PASAT) scores. After 24 months of treatment, the reduction in relapse rate persisted in favour of the Trimesta plus Copaxone treatment group compared to the Copaxone plus placebo group (32%). Both treatment groups exhibited improvement in measures of cognitive function at 24 months. Treatment was safe and well tolerated with no evidence of adverse effects on breast or uterus.

Voskuhl’s work is supported by grants exceeding US$8 million, which were awarded primarily by the National Multiple Sclerosis Society (NMSS) in partnership with the NMSS’s Southern California chapter, and the National Institutes of Health (NIH).