Biogen's (BIIB) Anti-LINGO Data Better then Expected; Stifel Affirms at 'Hold'
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Stifel affirms Biogen (Nasdaq: BIIB) at Hold following the release of Anti-LINGO data.
The firm commented:
Biogen finally released a sea of molecular and subgroup data from the SYNERGY trial. We find the detailed data much more encouraging that the Company’s original topline release and to our eyes responder analyses strongly suggest activity in the 10mg/kg and 30mg/kg subgroups. Other interesting features of the data include the poor efficacy of the highest dose group – consistent with meaningful brain penetration and better responses in all the expected groups including RRMS over SPMS and low numbers of brain lesions. Finally a correlation between patients that improved and some imaging endpoints suggests the company now has an assay (analogues to PET-imaging of A-beta plaque) to enrich further trials. The muted stock reaction suggests investors are looking at these data through a very different lens than was used for drugs like Solanezumab. MS is a degenerative disease; improvement in any patient group resulting from any duration of treatment could be very valuable.
Do we have a Subgroup? Detailed analysis of the SYNERGY study suggests that the least impacted subpopulation showed the most benefit from the treatment – a result that seems completely expected. For example, patients who at baseline had a “DTI score” of less than 0.73x10-3 showed the greatest clinical benefit on the primary endpoint, with an odds ratio of 6.35 (CI 2.43-16.62, p-value=0.0002) (Exhibit 1, DTI is an imaging parameter related to tissue integrity). Perhaps more importantly, this same parameter was seen to improve in patients marked as responders based on clinical improvements. As a result, Biogen seems to have an imaging biomarker it can use to enrich subsequent trials. This ability has been extremely valuable in the development of its AD antibody Aducanumab.
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