EuBiologics(206650) will attempt a clinical trial of a therapeutic vaccine that simultaneously targets amyloid beta (Aβ) and tau (Tau), the major pathological proteins of Alzheimer's disease.
EuBiologics said on the 18th that it has filed an investigational new drug (IND) application with the Ministery of Food and Drug Safety for a phase 1 clinical trial in Korea of its Alzheimer's disease therapeutic vaccine candidate "PediVax."
PediVax is a peptide-based therapeutic vaccine that targets both Aβ and tau. Unlike conventional antibody therapies that administer antibodies externally, it is being developed as an active immunization approach in which vaccination prompts the patient's body to produce antibodies that recognize Aβ and tau.
EuBiologics' immune-enhancing technology "EuIMT" and antigen display technology "SNAP" were applied to PediVax. The company said it confirmed in preclinical studies the generation of antigen-specific antibodies against Aβ and tau, and evaluated cognitive function improvement and safety in an Alzheimer's disease animal model.
In phase 1, safety and tolerability will be confirmed first in patients with mild cognitive impairment or mild Alzheimer's disease. At the same time, immunogenicity, including antibody generation against Aβ and tau, will also be assessed.
If the Ministery of Food and Drug Safety approves the clinical trial, participants will be enrolled into low-, mid-, and high-dose groups and randomly assigned with a placebo group. After a total of five administrations at 4-week intervals, the study will track long-term safety and immune responses.