New Spherix Data in Alzheimer’s Disease Reveals High Potential for Emerging Anti-Amyloid Therapies from Genentech, Biogen/Eisai, and Eli Lilly, As Well As Novo Nordisk’s Semaglutide
Differentiation amongst these pipeline agents will hinge on ease of access, easy-to-use companion diagnostics, and safety
EXTON, Pa., July 2022 – Despite multiple high-profile trial failures in early Alzheimer’s disease (AD) over the past several years, the pipeline remains robust, with several mechanisms of action (MOAs) being evaluated. Three late-phase anti-amyloid monoclonal antibodies – Biogen/Eisai’s lecanemab, Eli Lilly’s donanemab, and Genentech’s gantenerumab – are expected to read out over the next year and could help shape this evolving market.
Spherix recently surveyed 100 US neurologists and Alzheimer’s disease specialists and followed up with ten qualitative interviews to assess the current and future treatment paradigm for early AD patients. Insights, which are included in the Market Dynamix™ service, uncover referral patterns, diagnostic tools, drivers of treatment selection, and appetite for emerging therapies (among other factors).
While last year’s FDA approval of Biogen/Eisai’s Aduhelm as the first disease-modifying therapy (DMT) to treat AD initially appeared to be a turning point for this disease, the drug has been plagued by questions surrounding its risk- and cost-benefit profile. CMS’ recent decision to only reimburse Aduhelm for Medicare patients in the clinical trial setting will substantially limit use of the drug and leaves the market open for new DMTs (see Spherix’s Special Topix™: Impact of CMS Reimbursement Decision on Alzheimer’s Disease Therapies (US) for further insights).
Indeed, surveyed neurologists anticipate that their treatment approach for early AD patients will significantly change in the next three years, given the promise of the pipeline and that the diagnosis rate for early AD will increase with the launch of new DMTs. However, even with the potential availability of easier to use (and less invasive) biomarker tests for AD diagnosis, respondents lacked consensus on whether diagnosis would shift away from specialists to PCPs, suggesting that neurologists will likely continue to be the primary drivers of AD patient management.
Among ten profiled pipeline therapies, donanemab emerged as the most preferred agent to gain FDA approval; neurologists mentioned (unaided) its potential efficacy as the top advantage of the drug. Notably, gantenerumab’s differentiated dosing profile as a subcutaneous injection rather than an IV infusion stood out to neurologists as a key advantage of the drug.
However, neurologists estimate that lecanemab could garner a slightly higher peak share than donanemab or gantenerumab. The oral dosing profile of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist already approved for type 2 diabetes, was its main advantage – with the majority of neurologists anticipating prescribing the therapy within six months of approval for AD.
Neurologists’ high interest in tau-targeting mechanisms could bode well for UCB/Roche’s bepranemab, Eli Lilly’s LY3372689, and Janssen’s JNJ-63733657 if clinical data for these drugs prove positive. As noted by one interviewed neurologist, “The tau antibodies are intriguing, especially seeing if a microtubule binding region might work…you’ve got a number of small molecule tau agents. There’s still a lot of drugs out there with multiple different MOAs that I still think are pretty intriguing.”
About Market Dynamix™
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.
Learn more about our services here.
About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select dermatology, rheumatology, gastroenterology, nephrology, and neurology markets.
All company, brand or product names in this document are trademarks of their respective holders.
