Drug platform company Annovis Bio is set to continue its Phase II DISCOVER clinical trial of ANVS401 in patients suffering from Alzheimer’s disease.
The news comes after a Data Safety Monitoring Board recommended no modifications to the trial following analysis of the safety and demographic data, enrolment, status, and vital signs of the participants.
In preclinical studies, ANVS401 was found to normalise axonal transport by blocking the neurotoxic proteins that kill nerve cells. The drug showed encouraging tolerability profile in three Phase I trials involving patients with different neurodegenerative diseases.
Apart from Alzheimer’s disease, ANVS401 is being developed to treat Parkinson’s disease (PD) and Alzheimer’s in Down Syndrome (ADDS).
The Phase II trial is assessing the effect of the drug candidate on neurotoxic proteins in the spinal fluid of Alzheimer’s disease patients. Stable isotope labelling kinetics (SILK) will be employed to determine the effects.
In addition, ANVS401’s safety, pharmacokinetics, pharmacodynamics and efficacy will be investigated.
DISCOVER is being performed at the University of California, San Diego, Johns Hopkins, Indiana University, Washington University, the Cleveland Clinic, and Columbia University.
The trial is designed to enrol a total of 24 patients and has recruited 11 patients to date.
Analysis data did not show any adverse events in the participants. Interim results from the study are expected to be available later this year.
Annovis Bio CEO Maria Maccecchini said: “We are extremely pleased that the Data Safety Monitoring Board has unanimously supported that the study continues without modification. This trial will provide proof of mechanism and proof of concept for ANVS401.
“It will also provide the necessary dose range and safety information we need to progress our drug development into pivotal Phase II/III clinical efficacy studies.”
Funding for the Phase II trial is supported by the National Institute on Aging ADCS grant.