Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) reports that its multiple sclerosis treatment Laquinimod continues to be effective and well tolerated in an extension phase of an earlier trial, and Copaxone showed success in treatment at very early stages of the disease.
New data from the extension phase of oral Laquinimod in relapsing-remitting multiple sclerosis (RRMS) showed a "significant reduction in the mean number of gadolinium-enhancing (GdE) lesions in both patients who switched from placebo to Laquinimod and patients who continued with their initial Laquinimod dose."
The reduction in lesions in parties who switched from placebo to Laquinimod was 52%. The proportion of patients who switched to active treatment from placebo, and remained enhancing lesion-free, increased from 31% to 47%.
“These latest data show the rapid onset and sustainability of Laquinimod efficacy in MS patients,” said Dr. Giancarlo Comi of the University Vita-Salute San Raffaele, in Milan, who is principal investigator of the study. “Just as exciting is the fact that, with increased number of patients exposed to Laquinimod, we found no new risks or safety issues. This reinforces earlier results demonstrating the Laquinimod safety profile. The MS community looks forward to future data as we continue enrolling patients in the Laquinimod Phase III clinical program."
The present study is built on the initial 36-week, Phase IIb study results published in 'The Lancet", which showed that once-daily oral Laquinimod significantly reduced disease activity by a median of 60%, compared with the placebo, and was well tolerated.
In a separate development, Teva reported new data from its PreCISe study, in clinically isolated syndrome patients, which demonstrated that Copaxone significantly improved neuro-axonal integrity in patients presenting with a first clinical event suggestive of multiple sclerosis, compared with patients taking the placebo. The effect was maintained over two years of treatment. The data represent the first evidence of neuro-axonal protection by a disease modifying therapy in patients presenting with a first clinical event suggestive of multiple sclerosis.
The 243 patients treated with Copaxone had a 45% reduction in the risk of developing clinically definite multiple sclerosis (CDMS) compared with the 238 patients who received the placebo.
“These newly announced data, so far shown in RRMS patients treated with Copaxone, provide more evidence that treatment may control the neuronal damage associated with MS disease pathology,” said Dr. Douglas Arnold, Professor of Neurology at McGill University who is the primary investigator of the study. “The PreCISe trial demonstrated a significant benefit of Copaxone on both clinical and MRI disease activity, along with further reinforcing the excellent safety profile."
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