Nyrada Inc. released its September quarterly report this morning – ASX release attached. The most significant point which Canary would like to draw your attention to is the enhanced trial design of the phase 1, first in human trial of the company’s PCSK9i drug designed to lower cholesterol (see slide from the recent Share Cafe presentation below). The trial will now include two new cohorts of volunteers with high cholesterol (8 of which are taking statins in cohort 10). This is in addition to 64 healthy volunteers participating in the trial.
Advantages of Modified Trial Design
Nyrada will get an indication of how well the new drug lowers LDL cholesterol levels from cohorts 9 and 10
It is hoped that incremental cholesterol lowering benefits will be shown in participants taking statins in cohort 10
The company will be able to progress straight to a phase 2 trial, accelerating the pace of the clinical program
The design changes provides a more cost-effective transition to a phase 2 trial
Nyrada does not expect to have any trouble finding participants for cohorts 9 and 10 given how common high cholesterol is in the community. Preclinical safety and toxicology studies are underway with the phase 1 trial anticipated to commence during the first half of calendar year 2023.
