Active Biotech. has regained global development and commercialization rights of laquinimod, an investigational immunotherapy for neurodegenerative diseases, including Huntington’s disease (HD) and multiple sclerosis (MS).
After several years working together to advance laquinimod to the market, Teva will give Active Biotech full rights and data generated by the preclinical and clinical development program it has conducted since 2004.
“We are grateful for the good collaboration with Teva and for the broad development program that has been carried out for laquinimod,” Helén Tuvesson, chief executive officer of Active Biotech, said in a press release.
“The pronounced effect of laquinimod on brain atrophy demonstrated in both RRMS [relapsing-remitting multiple sclerosis] and [Huntington’s] patients supports our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases, where the medical need remains high. Therefore, we will assess all opportunities for a continuation of the development of laquinimod,” Tuvesson said.
Laquinimod is an oral active modulator of the immune system that changes the behavior of immune cells of the central nervous system, targeting brain inflammation and neurodegeneration.
Preclinical animal studies have shown that laquinimod increases the amount of a substance called brain-derived neurotrophic factor (BDNF) and prevents programmed cell death. BDNF is essential for the survival of nerve cells, and is present at lower-than-normal levels in patients with Huntington’s.
Laquinimod’s therapeutic potential showed inconsistent results when tested in clinical studies.
Laquinimod has been studied in the Phase 2 LEGATO-HD trial (NCT02215616), designed to evaluate the therapy’s effectiveness and safety in Huntington’s patients. Patients were treated with either three daily doses of the potential therapy (0.5 mg, 1 mg and 1.5 mg) or a placebo. However, the 1.5 mg was discontinued in January 2016 because of heart safety concerns found in MS studies.
Although the compound failed to meet the study’s primary endpoint of improving motor function in Huntington’s patients after 12 months of treatment, laquinimod met the secondary endpoint of reducing brain atrophy in these patients.
Active Biotech and Teva announced the expansion of laquinimod’s program in 2014, working closely for four years, now ending the collaboration.
Laquinimod has been granted orphan drug status in the United States by the Food and Drug Administration (FDA), which provides for seven years of market exclusivity in the event of future registration.