Vectus Biosystems Limited Announces Completion of Phase Ia for VB0004
the time to achieve the maximal concentration (Tmax) of VB0004 occurred six to eight hours after dosing and that the plasma half-life (the time taken for the plasma concentration of VB0004 to decrease by 50%) was 10 to 15 hours on both Days 1 and 14. The data also suggests that little to no accumulation of VB0004 occurred with time in normal individuals. This data reinforces the previous evidence that VB0004 will be amenable to once daily dosing, a desirable feature in medications for chronic conditions such as hypertension, heart failure, kidney failure and pulmonary fibrosis. To-date the Committee has reviewed data from all five planned Single Ascending Dose (S.A.D.) cohorts as well as all three planned M.A.D. cohorts. This Phase Ia trial has established an impressive safety profile for VB0004 with a maximum tolerated single dose of 300mg and no significant adverse events
seen in M.A.D. studies at 10mg, 30mg or 100mg administered daily over a 14-day period. Also established are consistent PK of six to eight hours to achieve maximal plasma concentration and a half life in excess of 10 hours. The Committee has now given permission for the Phase Ib section of the trial to commence. In this section of the clinical trial patients with uncomplicated hypertension will be treated for 28 days at a dose of 30mg of VB0004 per day. The trial is registered on the Clinical Trials Protocol Registration and Results Systems (ClinicalTrials.gov) and has been provided with the identifier NCT04925050. Protocol details may be found using this number on the ClinicalTrials.gov public website.