Annovis Bio

The Alzheimer's drug development landscape has expanded significantly beyond anti-amyloid antibodies, with 88 different clinical trials currently recruiting patients and twelve Phase 3 trials expected to report results in 2025.

Annovis Bio's buntanetap demonstrated significant improvements in cognitive function for early Parkinson's disease patients with mild dementia in a Phase III clinical trial, preventing cognitive decline compared to placebo.

Annovis Bio initiated a Phase 3 trial of buntanetap for early Alzheimer's, aiming to assess both symptomatic and disease-modifying effects over 18 months.

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.

Annovis Bio received FDA clearance to proceed with Phase 3 trials for buntanetap in early Alzheimer's disease following a successful End-of-Phase 2 meeting.

• Annovis Bio received FDA clearance to begin Phase 3 trials for buntanetap in early Alzheimer's disease, with a 6-month symptomatic study slated for Q1 2025. • The company's Q3 2024 financial results show a reduced net loss per share of $0.97, compared to $1.63 in Q3 2023, alongside $13.6 million in cash reserves. • Annovis Bio has filed three new patents for combination therapies involving buntanetap, including pairings with Trulicity and Viagra, to enhance cognitive benefits. • Recent funding rounds, including $4.4 million from an ELOC facility and $7.1 million from warrant exercises, provide sufficient capital for Phase 3 trial preparations.

• 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.

Annovis Bio will present two scientific posters on Buntanetap's efficacy in early Alzheimer's disease at the CTAD conference in Madrid.

Annovis Bio received FDA clearance to proceed with Phase 3 trials for buntanetap in early-stage Alzheimer's disease following a successful End-of-Phase 2 meeting.