The late-stage trials – ASCLEPIOS I and II probed the efficacy and safety of ofatumumab 20mg given as a once-monthly subcutaneous injection, in comparison to daily once oral Aubagio 14mg in a total of 1,882 adult patients with multiple sclerosis (MS).
Both the studies met the primary endpoints, which were to prove superiority of the Novartis’ investigational drug to Aubagio. The parameter for these was lowering of the frequency of confirmed relapses as assessed by the annualized relapse rate (ARR) in patients treated for up to 30 months.
Novartis said that key secondary endpoints of delaying time to confirmed disability progression were also met in the ASCLEPIOS I and II studies.
Ofatumumab also delivered sustained efficacy, while showing a favourable safety profile, said the Swiss pharma giant. Its safety profile in the ASCLEPIOS studies is on par with the observations from phase 2 trials.
According to the pharma major, ofatumumab binds to the CD20 molecule on the B-cell surface, thereby inducing potent B-cell lysis and depletion.
The company reported positive phase 2b results for the investigational drug in MS patients in 2014. In the phase 2b trial, the anti-CD20 monoclonal antibody demonstrated a marked significant reduction in the number of new brain lesions in the first 24 weeks after its administration.
In August 2016, Novartis initiated ofatumumab’s phase 3 program in RMS. The Swiss company obtained rights for the monoclonal antibody from Genmab in MS and all other indications in late 2015.
Novartis will look to initiate submissions to health authorities to seek their approval for the investigational MS drug by the end of the year.
Novartis chief medical officer and global drug development head John Tsai said: “Ofatumumab, if approved, could be a highly attractive treatment option for a broad RMS patient population, including early MS.
“The powerful study results are a reflection of our commitment to reimagine MS treatment at all stages of the disease.”