Prothena

• Cognition Therapeutics' Phase 2 SHINE study demonstrates that Alzheimer's patients with lower p-tau217 levels showed 95% improvement on ADAS-Cog 11 and 108% better MMSE scores with zervimesine treatment versus placebo. • Dr. Mary Hamby, VP of Research at Cognition, will co-host a precision medicine workshop at the Neuroimmunology Drug Development Summit, focusing on optimizing patient selection for clinical trials. • The company's findings suggest plasma p-tau217 could serve as a simple blood-based biomarker to identify Alzheimer's patients most likely to benefit from beta amyloid-targeted therapies.

Prothena's Phase 3 AFFIRM-AL trial evaluates birtamimab in Mayo stage 4 AL amyloidosis patients, targeting a survival benefit with a p-value threshold of 0.10 per FDA agreement.

Inhibikase Therapeutics discontinues development of risvodetinib for Parkinson's disease after Phase II trial fails to show significant efficacy despite meeting safety endpoints.

The European Medicines Agency's (EMA) CHMP supports Leqembi's approval for early Alzheimer's, reversing its earlier negative opinion.

Research in the seven major markets (7MM) increasingly prioritizes disease-modifying therapies (DMTs) and treatments for non-motor symptoms of Parkinson's disease.

• Clinical research in Parkinson's disease (PD) is increasingly focused on disease-modifying therapies (DMTs) to address unmet needs beyond motor symptom management. • 66% of the 93 products in Phase I-III development target key mechanisms like alpha-synuclein aggregation and neuroinflammation to slow disease progression. • Late-stage DMTs include Annovis Bio’s Posiphen and BioVie’s Triolex, targeting alpha-synuclein inhibition and inflammatory mediators, respectively. • Research also emphasizes non-motor symptoms, with agents like Cerevance’s solengepras and IRLAB’s Pirepemat targeting postural instability and PD-dementia.

• Clinical research in the seven major markets (7MM) for Parkinson's disease (PD) is heavily focused on disease-modifying therapies (DMTs) to address unmet needs. • 66% of the 93 products in Phase I-III development are prospective neuroprotective agents or DMTs targeting mechanisms like alpha-synuclein aggregation and neuroinflammation. • Researchers are also focusing on therapies for non-motor symptoms and postural instability, with 18% of the pipeline classified as 'other antiparkinsonian agents'.

• The Parkinson's disease (PD) therapeutic market faces unmet needs, notably the absence of neuroprotective/disease-modifying therapies (DMTs) and treatments for non-motor symptoms. • A significant portion of the PD drug development pipeline is dedicated to neuroprotective and disease-modifying agents, targeting mechanisms like alpha-synuclein aggregation and neuroinflammation. • Clinical trials are underway for therapies addressing postural instability, PD-dementia, and cognitive/emotional impairments, reflecting a comprehensive approach to managing PD's complexities.