Biogen (BIIB) Up on New Data From Phase III Studies on Aduhelm
Biogen BIIB announced new data from a pre-specified analysis of two phase III studies — EMERGE and ENGAGE — on Aduhelm (aducanumab) in patients with Alzheimer’s disease (AD) at the Clinical Trials on Alzheimer’s Disease conference.
Data from both the studies demonstrated that the drug achieved a significant reduction in plasma p-tau181, a biomarker of the hallmark tau tangles in AD in a dose- and time-dependent manner versus placebo. This reduction in plasma p-tau demonstrated a statistically significant correlation with reduced cognitive and function decline in AD patients.
Aduhelm received accelerated approval from the FDA earlier this year in June for the treatment of patients with mild cognitive impairment or mild dementia due to AD. The approval was based on data from the ENGAGE and EMERGE phase III studies in patients with early-stage AD. Data from both these studies demonstrated that Aduhelm has reduced amyloid beta plaques by 59-71% at 18 months of treatment.
In the latest data release, Biogen noted that the reduction in p-tau181 was significantly correlated with changes in the lowering of amyloid beta plaque. Biogen also noted that the effect of the decline was greater in patients who were treated with higher doses of Aduhelm and at a longer duration. Participants who were administered Aduhelm in the EMERGE study reported a p-tau reduction of 13% compared to placebo whose p-tau rose by 8%. Meanwhile, participants administered Aduhelm reported a reduction in p-tau by 16% in comparison to placebo, which rose by 9%.
Per the company, while Aduhelm did achieve statistical reduction in two hallmarks of AD, i.e. amyloid beta plaque and p-tau181, it also demonstrated a statistically significant correlation of these two hallmarks, with a decline in cognitive and functional decline in AD patients. Shares of the company were up 3% in the after-market trading session on Nov 11, following the news. In fact, Biogen’s shares have risen 8.9% so far this year against the industry’s 14.2% decline.
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Despite being the first medicine to be approved for reducing the clinical decline in AD indication and targeting the underlying cause of the disease, Aduhelm has had a slower-than-expected launch. The drug’s FDA approval faced a lot of criticism about its mixed efficacy results. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval last November due to mixed outcomes data from the ENGAGE and EMERGE phase III studies. In fact, the drug also comes with a hefty price tag of $56,000 a year, which was widely condemned. These issues have seemingly affected demand, patient access and reimbursement for Aduhelm. The drug recorded sales of $0.3 million for third-quarter 2021, which was lower than expected.
While Aduhelm has garnered several negative headlines, it has also put a spotlight on AD since its controversial approval. Bigwig companies like Roche RHHBY and Eli Lilly LLY, which are also preparing their own AD candidates, show promise.
Roche’s pipeline candidate for AD, gantenerumab, is an anti-amyloid beta antibody developed for subcutaneous administration. Last month, Roche announced that gantenerumab was granted the Breakthrough Therapy Designation by the FDA in October based on data that showed that the candidate significantly reduced brain amyloid plaque in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension studies as well as other studies.
Eli Lilly is evaluating donanemab, an investigational antibody therapy for AD. The company's phase II study, TRAILBLAZER-ALZ, investigated the efficacy and safety of donanemab in patients with early, symptomatic AD. Lilly has already initiated a rolling submission with the FDA seeking approval for donanemab under the accelerated approval pathway based on data from TRAILBLAZER-ALZ.
Apart from Aduhelm, Biogen is also developing another drug, lecanemab, an investigational anti-amyloid beta protofibril antibody, as a treatment for early AD in collaboration with Eisai. Earlier in September, Eisai initiated a rolling submission of a biologics license application (BLA) seeking approval under accelerated pathway for lecanemab in the given indication. The BLA is supported by data from a phase IIb study, which showed that treatment with lecanemab resulted in a consistent reduction of clinical decline across several clinical endpoints in patients with early AD and confirmed amyloid pathology.
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Zacks Rank & Stock to Consider
Biogen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Sarepta Therapeutics SRPT, currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sarepta’s loss estimates per share estimates for 2021 have narrowed from $7.15 to $4.99 in the past 30 days. The same for 2022 has narrowed from $5.00 to $3.61 in the past 30 days. Sarepta’s earnings beat estimates in two of the last four quarters and missed on the other two occasions, delivering an average surprise of 11.06%. Sarepta’s stock price closed at $86.10 at the end of the Nov 11 trading session.
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