Alzheon, Inc. Announces First Patient Dosed in Long-Term Extension of APOLLOE4 Phase 3 Trial of Oral ALZ-801/Valiltramiprosate and Launches 52-Week Extension of Phase 2 Biomarker Trial in Patients with Early Alzheimer's Disease

Alzheon, Inc. announced the dosing of the first patient in a long-term extension of the ongoing pivotal APOLLOE4 Phase 3 trial of 265 mg oral tablet of ALZ-801/valiltramiprosate, administered twice daily, in Early AD subjects carrying two copies of the e4 allele of the apolipoprotein E gene (APOE4/4 homozygotes). Early AD includes patients with mild cognitive impairment due to AD (MCI) and mild AD. ALZ-801/Valiltramiprosate is an investigational oral disease-modifying therapy in Phase 3 development for the treatment of Early AD.

In mechanism of action studies, ALZ-801 fully blocked the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose. Oral ALZ-801 has shown both potential for robust clinical efficacy in the highest-risk and most fragile late-onset Alzheimer's population - patients with two copies of the apolipoprotein e4 allele (APOE4/4 homozygotes), and favorable safety with no increased risk of vasogenic brain edema. The long-term open label extension of the APOLLOE4 Phase3 trial will continue to evaluate safety and efficacy of ALZ-801 tablet in APOE4/4 homozygous subjects with Early AD.

Participants in the APOLLOE4 phase 3 trial who completed Week 78 of the study and who are still eligible, are offered enrollment in the long-term extension and will be treated with ALZ-801 for 52 weeks, followed by a four-week safety visit after the last dose of ALZ-801. The primary objective of the APOLLOE 4 trial is to measure the impact of ALZ-801 on cognition using the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog). ALZ-801/valility is a potential first-in-class, investigational oral disease-modify therapy in Phase 3 development for The treatment of early Alzheimer's disease.

In mechanism-of-action studies, ALZ-801fully blocked the formation of neurotoxicuble beta amyloid (Ab) oligomers at the Phase 3clinical dose. ALZ-801 has shown potential for robust clinical efficacy in The highest-risk AD population - patients with two copies the apolipoprotein e 4 allele (APOE4/4 homozygotes), and favorable Safety with no increased risk of vasogen edema.