3.3.2. SUNBEAM

The SUNBEAM phase III study [99] included 1,346 patients with RRMS, randomized to daily oral OZM 0.5 mg (*n* = 451) or 1 mg (*n* = 447) versus weekly intramuscular 30 μg IFNβ-1a IM (*n* = 448). Inclusion criteria included ages 18–55 years, EDSS 0.0–5.0, diagnosis of RRMS, with the same remaining inclusion and exclusion criteria as RADIANCE Part B. Only the data for 1 mg OZM is presented.

The primary endpoint in SUNBEAM was ARR with OZM treatment versus IFNβ-1a over 12 months of observation. Key secondary endpoints included number of new or enlarging T2 brain lesions, number of Gd+ brain lesions at one year, and time to three-month CDP. Other secondary endpoints included whole brain volume loss. Exploratory endpoints included cortical grey matter and thalamic volume changes at one year. ARR at one year was 0.181 for OZM and 0.35 for IFNβ -1a treated patients, a relative risk reduction of 48% (*p* < 0.0001) favoring OZM treated patients. There was a 48% relative reduction in the number of new or enlarging T2 brain lesions favoring OZM-treated patients (*p* < 0.001) and total number of Gd+-brain lesions reduced by 63% in the OZM treatment arm (*p* < 0.0001) compared to IFNβ-1a. There was no statistically significant di fference between OZM and IFNβ-1a for time to three-month CDP. There was a 33% relative reduction (*p* < 0.0001) in percentage whole brain volume decrease for OZM treated patients, as well as an 84% (*p* < 0.0001) relative reduction in cortical grey matter loss and a 39% (*p* < 0.0001) relative reduction in thalamic volume loss in OZM treated patients. It is of particular interest to learn the results of on-going studies which are focused on cognitive functioning and patient reported outcome status [100] in light of the demonstrated relative reduction in cortical gray matter and thalamic volume loss in OZM treated patients.

The regulatory approval for the higher OZM dose is a 92 mg capsule, as opposed to the 1.0 mg OZM hydrochloride tablets used in the clinical trials [85].
