Our Approach at Alzheon
We are building on new insights into AD to target APOE4 patients.
The Right Patients: APOE4/4 Mild AD for confirmatory Phase 3 study
- Homogeneous population of patients overexpressing Aβ pathology
- Focus on the early stage of AD where Aβ oligomers a play key role in disease progression
The Right Drug: Improved ALZ-801 oral prodrug formulation
- Consistent plasma levels provide for high brain penetration to inhibit Aβ oligomer formation
- No vasogenic brain edema in tramiprosate clinical trials
The Right Trial: FDA accepted trial design in APOE4/4 AD patients
- Designed to confirm efficacy signals with same validated cognitive & functional measures
- Favorable safety observed with tramiprosate in clinical trials involving more than 2,000 subjects
- FDA agreed to the use of tramiprosate safety data for an NDA submission with ALZ-801
- Fast Track designation granted by FDA for ALZ-801 AD program