MS treatment staggers – but is it out?
Petach Tikva/Lund – Active Biotech AB suffered a severe setback in the development of its oral multiple sclerosis drug laquinimod. Together with ally Teva (Israel), the Swedish drugmaker announced that the substance failed in Phase III testing. A joint statement from the two companies stated that “results showed that the BRAVO study did not achieve its primary endpoint of reducing the annualised relapse rate.” However, there was data demonstrating significant reduction in brain-volume loss and the risk of disability progression. Teva said that study participants showed a 21.5% annual reduction in relapses, a 27.5% reduction in brain volume loss and a 33.5% reduction in the risk of disability progression – as measured by the Expanded Disability Status Scale – compared to those who received a placebo. Despite the setback, the drugmaker remains committed to laquinimod, Teva officials told analysts during a conference call. And data adjustment might do the trick. MRI scans showed patients in the laquinimod group had more brain lesions, which indicates they had more severe multiple sclerosis. If study results are adjusted to remove that imbalance, laquinimod might meet its primary goal of lowering the relapse rate. Analysts remained unconvinced: “We are not aware of a precedent case where an MS drug was approved without two statistically significant trials,” said Christopher Holterhoff from Oppenheimer & Co Inc. Analysts from Nordea Markets slashed the price target for Active Biotech to SEK40 from SEK70, while at the same time upgrading its recommendation from “Sell” to “Hold”. The company’s shares have dropped by about 60% since the beginning of August.