EARLY ALZHEIMER'S DISEASE

Eli Lilly's Kisunla has been approved by the FDA to treat early symptomaticAlzheimer's disease. Phase 3 data demonstrated that Kinsula significantly slowscognitive and functional decline by up to 35% over 18 months and reduced amyloidplaques by 84% on average. Results indicated that patients had up to a 39%reduced risk of progressing to more advanced stages of the disease, with nearly half completing their treatment in just 12 months.

DIAGNOSTIC INNOVATION

Advancements in Alzheimer's diagnostics are on the horizonwith two studies highlighting high accuracy in blood tests,providing a less invasive alternative to current diagnosticmethods. Sunbird Bio's blood-based tau biomarker technology demonstrates a 92% correlation with PET scans,efficiently detecting tau aggregation in the brain.PrecivityAD2's blood test shows a 91% diagnostic accuracy,exceeding the performance of standard clinical evaluationsthat hover around 61-73%. Both studies presented at AAIC2024 underscore the potential for blood tests to replace orsupplement PET and CSF tests, potentially improving early diagnosis, patient outcomes, and streamlining diagnostic processes in both primary and specialist care settings.

REGULATORY DECISIONS

The FDA has granted approval for Alpha Cognition’sZUNVEYL, previously known as ALPHA-1062, as a treatment for mild-to-moderate Alzheimer's disease. ZUNVEYL is the first treatment to addressAlzheimer's without being absorbed through the GI tract and has a dual mechanism of action as acholinesterase inhibitor and allosteric potentiator topromote activity of acetylcholine in the brain which is important for memory, motivation, and attention.Following the administration of the drug, only 0.06%of a 24mg dose of benzgalantamine reachessystemic circulation, effectively bypassing the gutand reducing side effects.

REGULATORY DECISIONS

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) hasrecommneded against granting marketing approval for Eisai and Biogen’s Alzheimer's drug, Leqembi, due to significant safety concerns and its marginal benefit inslowing cognitive decline. Clinical trials showed the drugslowed cognitive decline by 27% among early-stageAlzheimer's patients, but the CHMP decision noted cases of brain swelling, and found its impact on memoryand problem-solving to be minimal. Despite receiving accelerated approval in the US for early-stage AD, thetherapy's US launch has also faced hurdles like requisitediagnostic tests and regular brain scans.

MARKET DYNAMICS

Asceneuron has secured $100 million in Series Cfunding to advance their oral OGA inhibitor ASN51 into a Phase 2 Alzheimer's trial. The funding round, led by Novo Holdings, comes with the aim to compete with industry giants Eli Lilly and Biogen in the tau targeting therapeutic space. Lilly's LY3372689 andBiogen's BIIB113 both deviate from the typicalamyloid-targeting treatments available on the market,and are in Phase 1 and Phase 2 clinical trials,respectively. Asceneuron will evaluate ASN51 in direct competition with these tau-targeting treatments, and will also pursue additional indications, such asParkinson's and amyotrophic lateral sclerosis.

MARKET DYNAMICS

AbbVie is ending development of ABBV-916 as amonotherapy for Alzheimer's due to its inability to dedifferentiated from approved treatments. The decision follows an interim analysis of a Phase 2 studyinvolving 195 participants, which showed similar efficacy and safety profiles to existing therapies, such as Eli Lilly’s donanemab and Eisai / Biogen’s Leqembi.Despite discontinuing ABBV-916, AbbVie is exploringcombination treatments and remains invested inneuroscience, including an $8.7 billion acquisition of Cerevel Therapeutics.