In full transparency, the following press release & photo were submitted to SOURCE media through its business wire service.
FRAMINGHAM – Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, this week announced the appointment of Glenn E. Pauly as Head of Commercial.
ALZ-801 (valiltramiprosate) is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD that blocks formation of neurotoxic soluble beta amyloid (Aβ) oligomers causing cognitive decline in Alzheimer’s patients. In mechanism of action studies, ALZ-801 fully inhibited the formation of amyloid oligomers at the Phase 3 clinical dose. ALZ-801 has shown potential for robust efficacy in the highest-risk Alzheimer’s population – patients with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), and favorable safety with no events of brain vasogenic edema, as seen in trials with plaque-clearing antibodies. This population is the focus of Alzheon’s pivotal Phase 3 APOLLOE4 trial and has the highest likelihood of demonstrating successful efficacy outcomes.
“Alzheon has experienced tremendous growth and progress in the past year, and today’s announcement of industry-leading disease modifying effects from our Phase 2 trial provides further validation of Alzheon’s pioneering precision medicine approach in blocking formation of amyloid oligomers, as well as the advantages of our path over infusions of plaque-clearing antibodies,” said Martin Tolar, MD, PhD, Alzheon Founder, President, and Chief Executive Officer. “These advances and our strong financial position, following the recent completion of the oversubscribed $50M Series D round, combined with the prestigious grants awarded by the National Institute on Aging totaling $51M, attracted top talent to Alzheon, to build a world-class development and business organizations. These funds will allow us to accelerate clinical trials leading to NDA submission and commercialization of ALZ-801, to potentially become the first oral agent that can slow or even stop and prevent Alzheimer’s pathology in all patients and healthy individuals at risk for the disease.”
Pauly brings to Alzheon more than 20 years of commercial launch experience in the biopharmaceutical industry. He has extensive experience with launching disease-modifying agents in multiple therapeutic areas working across multiple commercial functions including sales, account management and market access. Most recently, Mr. Pauly was the U.S. Western Division General Manager and Vice President for Alzheimer’s Disease at Biogen with responsibility for commercialization of Aduhelm®. Previously, Mr. Pauly has held commercial and executive roles at Johnson & Johnson, Genentech, and AstraZeneca, where he supported successful launches and commercialization for multiple products including Remicade®, Actemra®, Xolair® and Fasenra®.
“It is an incredibly exciting time to be joining Alzheon,” said Pauly. “Our lead molecule, ALZ-801, has an opportunity to be decisively disruptive in a market searching for viable therapeutic options. The ability of ALZ-801 to prevent the formation of neurotoxic amyloid-beta oligomers is unique and provides an attractive alternative to current plaque-removal strategies applied by amyloid-targeting antibodies. A precision medicine approach with an initial focus on patients carrying two copies of the APOE4 gene allows for a simplified diagnostic journey. Importantly, the oral mode of administration minimizes the potential burden patients and caregivers may endure in order to receive disease-modifying therapies and may also reduce the organizational infrastructure needs and healthcare resources required to manage patient care. I am looking forward to building a competitive commercial organization to support the potential launch of this breakthrough therapy.”
Alzheon has developed a well-differentiated solution to both treatment and prevention of Alzheimer’s disease and other neurodegenerative disorders with a broad platform of small molecules, which act upstream on the same pathway as anti-amyloid antibodies, preventing the formation of neurotoxic soluble amyloid oligomers without disrupting the insoluble plaque deposits in brain tissue and small vessels. ALZ-801 is, therefore, in a class of its own as an easy to administer oral tablet that has shown the potential for robust efficacy with a favorable safety profile, avoiding the vascular complications of brain edema and microbleeds seen with infusions of plaque-clearing antibodies.