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Phase 2 study in multiple sclerosis: Opicinumab, an anti-LINGO-1, has missed the primary endpoint


The results from the phase 2 SYNERGY study evaluating Opicinumab ( anti-LINGO-1 ), an investigational, fully human monoclonal antibody being developed as a potential neuroreparative therapy in people with relapsing forms of multiple sclerosis ( RMS ) were reported.
In the study, Opicinumab missed the primary endpoint, a multicomponent measure evaluating improvement of physical function, cognitive function, and disability. However, evidence of a clinical effect with a complex, unexpected dose-response was observed.

Opicinumab also did not meet the secondary efficacy endpoint in SYNERGY, which evaluated the slowing of disability progression.
Safety and pharmacokinetics ( PK ) were also assessed as secondary endpoints.
Opicinumab was generally well-tolerated and the safety profile was consistent with what has been observed in prior studies. Opicinumab showed a linear, well-behaved PK profile over the studied dose range.

Opicinumab phase 2 development program

The two phase 2 trials ( RENEW and SYNERGY ) were designed to assess the biological activity and clinical potential of Opicinumab in central nervous system demyelinating diseases.

RENEW was a randomized, double-blind, placebo-controlled phase 2 study designed to evaluate the effect of Opicinumab treatment following a first episode of acute optic neuritis.
Opicinumab 100 mg/kg was administered intravenously once every four weeks for 20 weeks ( total of six doses ).
Results from RENEW showed improved latency recovery, as measured by the primary endpoint full-field visual evoked potential ( FF-VEP ), among Opicinumab participants, compared with placebo.
The study showed no effect on the secondary endpoints of change in thickness of the retinal layers ( optic nerve neurons and axons ) or visual function, as measured by spectral domain optical coherence tomography ( SD-OCT ) and low contrast letter acuity, respectively.

SYNERGY was a randomized, double-blind, placebo-controlled, dose-ranging phase 2 study that evaluated the impact of Opicinumab among 418 participants with relapsing forms of multiple sclerosis ( both relapsing-remitting and secondary progressive ) over 72 weeks.
The primary endpoint of the SYNERGY study was a multicomponent measure evaluating the number of study participants who experienced three month confirmed improvement of ambulation ( Timed 25-Foot Walk; T25FW ), upper extremity function ( 9-Hole Peg Test; 9HPT ), cognition ( 3-Second Paced Auditory Serial Addition Test; PASAT ) and standard measures of physical disability ( Expanded Disability Status Scale; EDSS ).
Secondary endpoints measured slowing of progression on the same components, as well as the safety and pharmacokinetics of Opicinumab.
Statistical testing assessed the dose-response trend based on the primary or secondary endpoint. Opicinumab was administered intravenously every four weeks at doses of 3 mg/kg, 10 mg/kg, 30 mg/kg or 100 mg/kg.
All study participants received concurrent treatment with 30 mcg Interferon beta-1a intramuscular injection once weekly. ( Xagena )

Source: Biogen, 2016

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