Trial Design Likely Boosted Biogen (BIIB) BIIB037 Efficacy Data - Nomura

While many are signing the praises of Biogen (NASDAQ: BIIB) this morning following Phase Ib data for BIIB037 in Alzheimer’s disease (AD), Nomura analyst M. Ian Somaiya is not so sanguine - asking "was it the drug or the trial design?"

Somaiya commented, " The Phase Ib efficacy data exceeded even the most bullish investor expectations based on benefit on the Mini Mental State Examination (MMSE) and clinical dementia rating (CDR) scale. However, the degree of benefit seems to be driven by more rapid deterioration of the placebo group compared to prior studies in mild-to-moderate AD, despite the enrollment of only mild patients in this trial. We therefore believe the dramatic benefit seen in this trial was more a reflection of a well-designed study (i.e., others can do the same) than novelty of the drug. Overall, we believe the 3mg/kg dose represents the safest dose, with the 10 mg/kg dose unlikely to move forward based on higher incidence of ARIA-E in Apo E4 carriers and non-carriers. We await efficacy data from the 6 mg/kg dose to determine if BIIB037 will provide the flexibility of a minimally effective dose and high efficacy dose moving into Phase III trials, which would increase in our view probability of regulatory and commercial success."

The firm maintained a Neutral rating and price target of $401 on BIIB.

For an analyst ratings summary and ratings history on Biogen click here. For more ratings news on Biogen click here.

Shares of Biogen closed at $433.65 yesterday.

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