BioWorld International Correspondent

Swedish firm Active Biotech AB soared to a 12-month high on the Stockholm stock exchange Tuesday, following positive news from a Phase II trial of laquinimod (SAIK-MS), an oral treatment for multiple sclerosis.

The shares climbed 41 percent Tuesday to close at SEK50.

The compound attained its primary endpoint in a placebo-controlled study involving 209 patients based in 20 treatment centers in Sweden, the UK, Russia and the Netherlands. The primary data analysis was based on an assessment of 187 patients. It indicated a 30 percent reduction in disease activity - as measured by magnetic resonance imaging (MRI) - in patients receiving 0.3 mg/day of laquinimod as compared with those receiving placebo. Trial participants who received 0.1 mg/day of drug also showed a decline in disease activity compared to the placebo group, but that was not statistically significant.

So far, Active Biotech said, the primary analysis has failed to show any statistically significant differences with respect to two secondary endpoints that are related to clinical outcome: expanded disability status scale (EDSS) and the number of exacerbations. It attributed the duration of the treatment period - six months - to the former finding.

"You need one to two years to see a clear effect on the EDSS scale," Chief Scientific Officer Tomas Leanderson told a conference call audience. The trial also was characterized by a low relapse rate, the company said. The entire patient group experienced a relapse rate of just 25 percent during the treatment period.

Nevertheless, the company is confident that the MRI data represent evidence of efficacy, although it is still too early to establish the precise level. "No compound is known that has had effects on MRI and has not had effects on clinical outcome, but I don't think one can extrapolate quantitatively the results from MRI to the clinical effect," Leanderson said. The company plans to present a full analysis of the data at an analyst event in Stockholm Nov. 6.

"This is an extremely positive milestone for the project and the company," CEO Sven Andréasson told the conference call audience. "We are now ready to plan in more detail for the Phase III trials in parallel with the partner discussions, which are ongoing." The company, with the help of a partner, aims to move laquinimod into a Phase III trial next spring. "We will now evaluate the possibility of increasing the dose since our safety profile is so benign," Leanderson said.

"If we succeed through Phase III all the way up to registration, this can become with great certainty the first oral compound for treatment of multiple sclerosis. According to our knowledge, there is no other project as advanced as ours," Andréasson said.

Laquinimod, which is derived from Active Biotech's Q-platform, is thought to act by blocking the autoimmune responses that characterize multiple sclerosis. Scientists at the company previously reported that the compound abolished leukocyte infiltration into the central nervous system in murine models.

Active Biotech is the outright owner of the molecule. It purchased the interest of Pharmacia Corp. (now a subsidiary of New York-based Pfizer Inc.) in the final quarter of last year. The company will, however, make an additional payment of US$1.5 million to Pfizer on signing an agreement, Andréasson said.