Piper says significant read-through to Biogen drugs would be a “mistake,” while William Blair also highlights differences
An analyst at Piper Jaffray defended his Overweight rating on Biogen (BIIB) following this morning’s news that Roche (RHHBY) is discontinuing Phase 3 trials for its crenezumab drug for early Alzheimer’s disease.
BACKGROUND: Roche and its Genentech unit said Wednesday that it will halt CREAD 1 and CREAD 2, two late-stage clinical trials of its crenezumab drug for early Alzheimer’s disease, after an interim analysis indicated they were unlikely to hit the primary endpoint. Genentech had been working on the drug with AC Immune (ACIU). Roche said its decision to discontinue the studies was based on the results of a pre-planned interim analysis assessing the safety and efficacy of crenezumab conducted by the Independent Data Monitoring Committee, which indicated that crenezumab was “unlikely to meet the primary endpoint” of change from baseline in Clinical Dementia Rating-Sum of Boxes, or CDR-SB, Score. No safety signals for crenezumab were observed in this analysis, and the overall safety profile was similar to that seen in previous trials, the company said.
Roche said an Alzheimer’s Prevention Initiative, or API, study of crenezumab in familial Alzheimer’s disease, or fAD, in Colombia will continue in Phase 3 trials with gantenerumab and a phase 2 anti-tau trial. The company commented that “while the results with crenezumab are disappointing, they meaningfully contribute to our understanding of Alzheimer’s disease.” Meanwhile, AC Immune CEO Andrea Pfiefer said in a statement that the company is “extremely disappointed” about the outcome of the Phase 3 CREAD 1 interim analysis. The executive said AC Immune continues to be “optimistic about the potential future of crenezumab as we await the outcome of the Colombian API study to prevent AD symptoms in patients with familial AD to see if the antibody treatment may provide disease-modifying effects in patients with early-onset disease.”
IN DEFENSE OF BIOGEN: Piper Jaffray analyst Christopher Raymond maintained an Overweight rating on Biogen after Roche said it would discontinue the crenezumab trial. Raymond defended his rating in a research note by saying that key differentiators between crenezumab and BIIB’s aducanumab — and BAN2401 — exist, and, as with other A-beta targeting antibodies that have failed, crenezumab does not possess either the biology or the clinical data set of either aducanumab or BAN2401. Raymond, who recommends buying Biogen on weakness, contended that Biogen’s management has been “quick” to make key distinctions between crenezumab and its own molecules, including that crenezumab “lacks specificity for aggregated forms of a-beta that make up plaques,” and added that while its IgG4 backbone was designed to lower ARIA risk, the lack of effector function “likely hampers efficacy as well in that it hasn’t shown the kind of significant lowering of amyloid plaque burden that we’ve seen from aducanumab and BAN2401.” Given the differences, Raymond said a significant read-through to aducanumab or BAN2401 would be a “mistake.” Meanwhile, William Blair analyst Matt Phipps said there are fundamental differences between Roche’s crenezumab and Biogen’s aducanumab that make any read-through “very limited, if at all.” Roche’s decision to discontinue two Phase 3 studies evaluating crenezumab, an investigational antibody designed to target oligomers of beta-amyloid, in patients with Alzheimer’s disease does not change the analyst’s outlook for aducanumab. While Roche’s news will “undoubtedly be viewed negatively” for aducanumab, Biogen’s investigational antibody designed to target amyloid plaque, there are “very apparent differences between the antibodies,” Phipps contends. He points out that crenezumab has a more similar binding profile to solanezumab, and also is unique in having an IgG4 backbone, which reduces immune effector cell activation in an attempt to reduce the side effect known as amyloid related imaging abnormalities. Phipps keeps an Outperform rating on Biogen.
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