Active Biotech reports on initial results in ARPEGGIO Phase II trial.
M2 EQUITYBITES-December 4, 2017-Active Biotech reports on initial results in ARPEGGIO Phase II trial
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Active Biotech AB (STO:ACTI), a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer, announced on Friday initial results from the Phase II proof of concept study of laquinimod in Primary Progressive MS (PPMS) sponsored by Active Biotech's partner Teva Pharmaceuticals Industries Ltd.
Reportedly, the primary endpoint of brain atrophy as defined by percent brain volume change (PBVC) from baseline to week 48, was not met after daily oral doses with 0.6 mg laquinimod.
Also, the secondary endpoint of time to confirmed disability progression was also not met. There was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg.
According to the company, the clinical safety profile of laquinimod 0.6 mg daily in PPMS patients resembled the safety profile demonstrated in relapsing remitting MS patients. The most common adverse events reported by patients treated with laquinimod 0.6 mg daily were nasopharyngities, headache, upper respiratory tract infection and back pain.
The ARPEGGIO study is a multinational, multicentre, randomised, double-blind, parallel-group, placebo-controlled, Phase II trial evaluating the efficacy, safety and tolerability of laquinimod at 0.6 and 1.5 mg/day in patients with PPMS. The higher-dose (1.5 mg) arm of the trial was discontinued in January 2016.
This study has the primary endpoint of brain atrophy as defined by PBVC from baseline to week 48, assessed by magnetic resonance imaging (MRI) analysis. Secondary endpoints include time to confirmed disability progression, the number of new T2 lesions and extended MRI data.
Data from the trial will be presented at a future scientific conference and the full results will be published, the company added.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Dec 4, 2017|
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