Alzheon Appoints Renowned Biopharma Exec Gino Santini to Board

Alzheon, Inc., a clinical-stage biopharmaceutical company specializing in treatments for Alzheimer’s disease (AD) and other neurodegenerative disorders, has announced the appointment of Gino Santini to its Board of Directors. This move is strategically timed as Alzheon looks forward to a transformative year in 2024, with the planned readout of its APOLLOE4 Phase 3 trial and subsequent regulatory submissions.

Martin Tolar, MD, PhD, the Founder, President, and CEO of Alzheon, expressed enthusiasm about Santini's appointment. Tolar emphasized Santini’s potential to guide the company through the transition from clinical trials to regulatory procedures and commercial launch. Tolar also highlighted Alzheon’s unique approach to disease modification, which aims to overcome significant obstacles in the Alzheimer’s treatment market.

Santini’s professional background includes a prestigious career at Eli Lilly, where he held various leadership positions, culminating as Senior Vice President of Corporate Strategy and Business Development. He has been involved with several other pharmaceutical companies as a board member, bringing extensive experience to Alzheon. Santini holds a mechanical engineering degree from the University of Bologna and an MBA from the University of Rochester.

Santini’s addition to the Board comes as Alzheon is preparing for the potential approval and commercialization of ALZ-801 (valiltramiprosate). ALZ-801 is an investigational oral agent in Phase 3 development, designed to modify the disease course of Alzheimer’s. It works by blocking the formation of neurotoxic soluble beta amyloid oligomers, which are believed to contribute to cognitive decline in Alzheimer’s patients. The drug has shown promising results, demonstrating robust clinical efficacy and favorable safety profiles, including the absence of increased risk for brain vasogenic edema.

Alzheon has been conducting biomarker trials to evaluate the effects of ALZ-801 on Alzheimer’s pathology. The ongoing Phase 2 biomarker trial (NCT04693520) is focused on early AD patients who carry the APOE4 gene, which is present in a significant portion of the Alzheimer’s population. This trial assesses various biomarkers, clinical efficacy, safety, tolerability, and pharmacokinetics over a treatment period of up to 208 weeks.

The APOLLOE4 Phase 3 trial (NCT04770220) is designed to test the efficacy and safety of ALZ-801 in early AD patients who are homozygous for the APOE4 allele. This double-blind, randomized trial compares ALZ-801 to a placebo over a 78-week period, with a long-term extension to evaluate the drug's effects for up to 130 weeks. The trial is financially supported by a $51 million grant from the National Institute on Aging.

Alzheon, Inc. is committed to developing innovative treatments by targeting the underlying pathology of neurodegeneration. Their lead candidate, ALZ-801, is positioned as a first-in-class oral agent targeting neurotoxic amyloid oligomers. Alzheon’s approach leverages individual genetic and biomarker information to advance therapies that could have a significant impact on patients’ lives.

With the upcoming milestones in 2024, including the potential NDA submission and commercial launch of ALZ-801, Alzheon is poised for a pivotal year. The addition of Gino Santini to the Board of Directors is expected to provide the strategic and business acumen necessary to navigate this critical phase of the company’s development.