Biogen Idec has just announced its final first year results of the Phase 3 trial of its relapsing-remitting multiple sclerosis drug Plegridy (peginterferon beta-1a). The drug met all primary and secondary endpoints of the trial results indicating that it is very effective at reducing multiple sclerosis (MS) disease activity.
MS is a an autoimmune disease in which the immune system begins to attack the brain and spinal cord (central nervous system). Symptoms include weakness, inability to move arms or legs, loss of balance, and numbness.
Plegridy is a member of the interferon class of drugs, which are often used as first line treatment for MS. It works by extending the half-life and exposure of interferon beta-1a in the body. According to a previous study, published in the Archives of Neurology, interferon treatment is able to achieve and sustain a response as measured by regular magnetic resonance imaging evaluations.
The results, which were presented at the American Academy of Neurology‘s 65th Annual Meeting, revealed that in comparison to placebo, Pledigry reduced the annual relapse of patients with multiple sclerosis by 36 percent and reduced the proportion of patients who relapsed by 39 percent.
The Phase 3 ADVANCE clinical trial was a two-year-long study which aimed to evaluate the efficacy and safety of Plegridy in more than 1,516 randomized patients suffering from MS. It evaluated the effectiveness of two different doses of the drug given either every two or four weeks.
Peter Calabresi, M.D., director, the Johns Hopkins Multiple Sclerosis Center, said:
“These full first-year results provide a more complete picture of PLEGRIDY and its positive effects on the reduction of relapse, disability progression and lesion development. These data suggest that, if approved, PLEGRIDY may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with MS.”
Plegridy, dosed once every two weeks, showed numerically greater treatment effect than when dosed once every four weeks.
Gilmore O’Neill, Vice President, Global Neurology Late Stage Clinical Development at Biogen Idec, said:
“In the first year of the ADVANCE trial, PLEGRIDY demonstrated strong efficacy. We saw a marked reduction in relapse rate and this was supported by MRI results. If approved, PLEGRIDY will make an important therapeutic option in the injectable treatment segment. In addition to these encouraging therapeutic results, PLEGRIDY may reduce the treatment burden for patients by reducing the number of subcutaneous injections.”
Adverse events of the drug included redness at the area of the injection as well as influenza-like symptoms. However, overall, the drug performed well in terms of safety, with the number of adverse events among those taking Plegridy similar to those on placebo.