Clinical-stage biopharmaceutical company Alzheon has secured $100m in a Series E funding round to develop and commercialise ALZ-801/Valiltramiprosate, an oral tablet designed as a disease-modifying therapy for Alzheimer's disease (AD).
Alerce Medical Technology Partners spearheaded the financing round.
The development comes after the company raised $50m in a Series D round in 2022.
The investment will be used to complete the APOLLOE4 Phase III clinical trial to evaluate the efficacy of ALZ-801 in 325 early AD patients.
The study will report its results in the third quarter of 2024, with a new drug application (NDA) submission to follow.
ALZ-801 inhibits the formation of soluble toxic amyloid aggregates, acting upstream from all late-stage amyloid-targeting treatments.
The financial boost will also support the manufacture of the product and prepare for the potential launch of ALZ-801 commercially, as the first oral disease-modifying therapy for Alzheimer's.
ALZ-801 has demonstrated the ability to fully block the formation of neurotoxic soluble beta-amyloid oligomers at the Phase III clinical dose level.
It also demonstrated clinical efficacy in the highest-risk AD population and favourable safety, without causing higher brain vasogenic oedema risk.
ALZ-801 was also evaluated in a two-year, 84-patient, Phase II biomarker study completed in the second half of 2023.
The biomarker trial is now extending into a fourth year.
Alzheon founder, president and CEO Martin Tolar stated: “Alzheon has experienced tremendous progress in the past year and the promise of our novel oral Alzheimer’s treatment, ALZ-801, has attracted prominent institutional and private investors.
“Our ability to raise $150m over the last two financing rounds in the current climate speaks volumes about the prospects of our innovative science and technology.
“Our well-differentiated drug candidate with a favourable safety profile, showing no increased risk of vasogenic brain oedema in more than 3,000 AD patients, is positioned to potentially become the first oral disease-modifying therapy for the treatment of Alzheimer’s disease.”
