There are multiple different types of drugs available for the treatment of Alzheimer’s disease: cholinesterase inhibitors to treat symptoms from mild to severe, and disease-modifying immunotherapies to remove amyloid plaques and slow disease progression. In addition, vaccines that aim to clear the amyloid-beta plaques that accumulate in the brains of Alzheimer’s patients—or the neurofibrillary tangles formed by abnormal tau proteins—have been an area of active study.
Now, a vaccine moves one step closer to approval. The Swedish biopharmaceutical company Alzinova recently announced that the FDA has approved the company’s Investigational New Drug (IND) application for its planned Phase II clinical study with the vaccine candidate ALZ-101 for Alzheimer’s disease. The company’s clinical development specializes in the treatment of Alzheimer’s disease, at the starting point of attacking toxic amyloid-beta oligomers.
“The FDA’s approval of our IND is a decisive confirmation of our readiness to advance ALZ-101 into the next stage of development,” noted Tord Labuda, PhD, CEO of Alzinova. “The approval gives us the green light to initiate the Phase II study in the United States and to build on the promising results from Phase Ib, while for the first time evaluating our vaccine candidate in a larger patient population. This marks an important step in realizing the therapeutic potential of ALZ-101 and bringing us closer to our goal of making our vaccine candidate available to patients.”
ALZ-101, a vaccine that stimulates the production of antibodies against the toxic Aβ oligomers, is Alzinova’s lead candidate. The company ran a first-in-human clinical study to evaluate the safety and immunogenicity of the oligomer-specific therapeutic vaccine ALZ-101 and released favorable data from part A of its Phase Ib clinical trial in November 2023.
With the recent IND approval, the study design, safety data, and manufacturing processes have been confirmed to meet regulatory requirements, enabling Alzinova to proceed with preparations as planned. The approval also allows the company to take the next step in evaluating the promising results from the Phase Ib study in a larger patient population, a decisive step in confirming the therapeutic potential of ALZ-101.
The planned Phase II study with ALZ-101 is designed as a multicenter trial, including sites in the United States, with the objective of evaluating safety, tolerability, and efficacy in patients with early Alzheimer’s disease. The study will enroll approximately 240 patients. Following dosing, a series of follow-up visits is planned during which both primary (a cognitive test) and secondary endpoints (including safety and tolerability) will be assessed. The study will be conducted at several clinics in collaboration with the contract research organization Worldwide Clinical Trials.
