Multiple sclerosis (MS) and Parkinson’s disease involve serious unmet medical needs. Within our Neurodegenerative Diseases therapeutic area, we are conducting research to discover new therapeutic options.
REFLEX is the name of the most important ongoing clinical trial focused on the further development of Rebif®, our successful MS treatment. The two-year pivotal Phase III study is evaluating the efficacy of the new formulation of Rebif® in more than 500 patients with clinically isolated syndrome. Study participants with this clinical picture have so far experienced a single MS-like symptom, such as optical or sensory disturbances, and are at risk of developing MS but have not yet been given a clinically definite diagnosis of MS. The trial is designed to evaluate whether treatment with Rebif® in the early stages of the disease can delay the progression to clinically definite MS.
The results of the completed 40-week Phase IIIb IMPROVE study confirm the therapeutic effect of the new formulation of Rebif® in patients with relapsing-remitting MS. After 16 weeks of treatment, the number of combined unique brain MRI lesions in patients treated with Rebif® was significantly lower compared to placebo. This positive effect could be detected as early as four weeks after treatment initiation and was sustained over the 40-week trial period. The results after 16 weeks also showed a significant reduction in the relapse rate versus placebo and an improvement in injection site reactions.
Cladribine tablets for the oral treatment of MS submitted for regulatory approval
With cladribine tablets, the Merck Serono division is developing a drug for the oral treatment of relapsing-remitting forms of MS. Treatment would become considerably more convenient for patients and compliance could improve since a single daily tablet would only need to be taken a few times a year for four to five days. We submitted marketing authorization applications for cladribine tablets with the EMA in Europe in July and with the FDA in the United States in September. The submissions are largely supported by results of the CLARITY study, a two-year randomized, double-blind, placebo-controlled Phase III trial of cladribine tablets as a monotherapy in 1,300 patients with relapsing-remitting MS. A significant relative reduction in annualized relapse rates was seen in patients treated with cladribine tablets compared to placebo. Data from a post-hoc analysis of the CLARITY study show that short-course treatment with cladribine tablets significantly increased the proportion of patients with absence of disease activity compared to placebo. At the end of November, the FDA issued a refuse to file letter.
Merck Serono will work closely with the FDA to successfully resubmit the application at the earliest possible point in time.
The two-year Phase III ORACLE-MS study is investigating cladribine tablets as a treatment for patients with an increased risk of developing MS. In the Phase II ONWARD study, we are evaluating the safety and tolerability of adding cladribine tablets to established treatment with interferon beta. Patient recruitment has been completed.
We discontinued the development of atacicept in multiple sclerosis after observing in one of three Phase II clinical trials increased MS disease activity in patients taking atacicept compared to placebo.
New study started with safinamide in late-stage Parkinson’s disease
Together with our partner Newron, we are developing safinamide as an oral add-on therapy for patients with Parkinson’s disease, which affects an estimated three million people in industrialized countries. We successfully completed the first Phase III clinical trial of safinamide administered as an adjunctive therapy to levodopa standard treatment in patients with advanced Parkinson’s disease after a six-month treatment period. Motor functions and the ability to perform daily activities improved significantly in patients treated with safinamide compared to placebo. In May, we started SETTLE, our second Phase III clinical trial in this indication, which will involve more than 450 patients. We are evaluating safinamide as an add-on therapy to a dopamine agonist in early Parkinson’s disease in a Phase III clinical trial.
back
