Novartis ($NVS) released updated data for its MS candidate siponimod (aka BAF312) over the weekend which showed it can cut the risk of patients’ disability progressing by 21% when compared with placebo over three months.
The Swiss major posted top-line results from its Expand Phase III last month, but this is the first time it has revealed some deeper stats. Novartis also said that the risk reduction for 6-month confirmed disability progression “was greater, further supporting robustness of the data,” although it still has not published full figures for this.
“Novartis will complete full analyses of the Expand data and evaluate next steps in consultation with health authorities,” the Big Pharma said. It latest figures were announced over the weekend at London’s ECTRIMS conference.
Its experimental drug, a modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, is seeking to treat those with secondary progressive multiple sclerosis (SPMS).
This one of a number of subpopulations with the disease and is marked by continuous worsening of neurological function over time, independent of relapses. Other subpopulations include relapsing remitting and relapsing forms of MS, as well as primary progressive MS.
The Phase III data of more than 1,600 patients also showed a consistent reduction in the risk of confirmed disability progression across predefined subgroups, including patients without relapses, as well as a “significant difference in favor of BAF312 compared to placebo in annualized relapse rate, the percent change in brain volume, and change from baseline in the volume of T2 lesions (brain lesions identified by a T2-weighted magnetic resonance imaging scan).”
The company noted however that there was not a significant change in baseline when it came to the Timed 25-Foot Walk test (T25FW).
Some analysts have seen the med as an underappreciated, undiscovered gem in Novartis’ pipeline. In a note to investors, David Evans of Kepler Cheuvreux said he thought the drug had a 60% chance of hitting $3 billion peak sales. “An effective drug in SPMS would have a huge impact,” he added.
There are a number of meds on the market for the relapsing and remitting forms of MS, including those from Novartis ($NVS) in the form of its blockbuster Gilenya (fingolimod), Biogen ($BIIB), German Merck, Sanofi ($SNY), Teva ($TEVA) and others--but there are currently no drugs on the market for some of the progressive forms of the disease, which makes up around 10-15% of all MS patients.
Just last week its across-town rival Roche ($RHHBY) posted positive data from its late-stage for Ocrevus (ocrelizumab), showing it could best aging MS injectable Rebif (interferon beta-1a) in relapsing MS, as well as reducing the risk of disability progression by 24% in patients with the particularly debilitating and rare form of the disease, known as primary progressive multiple sclerosis (PPMS).
Roche is hopeful for an FDA approval just before the New Year, with a European approval slated for mid-2017--sales projections are averaging around the $4 billion a year at peak mark.
There are however many older meds that can be used to treat SPMS, including both Rebif and Gilenya, as well as Sanofi’s Lemtrada (alemtuzumab) and Novantrone (mitoxantrone)--a chemotherapeutic agent that has been approved by the FDA for SPMS, although this can come with some high AE risks.
Novartis, which has previously said it plans for a 2019 filing for its candidate, will be hopeful siponimod can produce better efficacy and safety to trump its rivals.
“There are very few available treatment options to delay disease progression in SPMS, and there is a high unmet need for effective therapies with an acceptable safety profile for people with the condition,” said Vasant Narasimhan, global head drug development and CMO for Novartis.
“Novartis is the global leader in understanding the role of S1P receptor modulation in the treatment of MS, and the positive results of the Expand study are a continuation of our ongoing efforts to innovate and meet the needs of patients. These data are a positive stride forward in an unserved disease area, and we look forward to evaluating next steps with health authorities.”