As promised earlier this year, Teva Pharmaceutical Industries of Israel has now initiated late-stage trials of laquinimod, which the firm hopes will be the first oral treatment to hit the market for multiple sclerosis.

Teva, along with its Swedish partner Active Biotech, has started enrolment in Allegro, a 24/30-month, Phase III study designed to evaluate laquinimod versus placebo in the treatment of relapsing-remitting multiple sclerosis (RRMS). The trial aims to enrol approximately 1,000 patients.

Recently, Teva concluded a 36-week extension of a 36-week Phase IIb core trial, which demonstrated that laquinimod 0.6mg met its primary endpoint and the majority of the patients that participated are now receiving treatment with the drug in a continued open-label extension trial. Additional new data has demonstrated that laquinimod may have both anti-inflammatory and neuroprotective properties.

Another Phase III trial in RRMS, called BRAVO, is expected to begin enrolment in the first quarter of 2008, which will provide risk-benefit data comparing once-daily orally administered laquinimod to a product already on the market. 1,200 participants will be followed for two years.

The excitement around laquinimod is based on the fact that it is an oral treatment. As Doug Jeffery of the Wake Forest University Baptist Medical Center, pointed out, there are several RRMS treatments available but “they are all administered via injection or infusion. An orally administered therapy brings us one step closer to offering patients and physicians a highly effective, new, convenient and less invasive method of drug delivery".

Teva is already a leading player in the MS market with the injectable Copaxone (glatiramer acetate) but previous attempts at attempting to produce an oral formulation have failed. In March last year, the company and partner Lundbeck shelved plans for a coated tablet formulation of Copaxone and the Israeli firm said that it had been developing a oral version for six years, but that two rounds of Phase II trials had failed to show an acceptable level of efficacy for the drug.

Other companies developing oral drugs for MS in late-stage trials include Novartis with FTY720 (fiungolimod) and Merck Serono with Mylinax (cladribine), while Sanofi-Aventis has teriflunomide.