Vectus Biosystems Limited announced the completion of the third and last of the three planned cohorts in the Multiple Ascending Dose (M.A.D.) segment of its first-in-human trial: "A phase I/Ib, first-time-in-human, single centre, double-blind, randomized, placebo-controlled, dose escalating study of the safety, tolerability and pharmacokinetics of single and repeat doses of VB0004 administered orally to healthy volunteers; and to patients with mild to moderate hypertension with low cardiovascular risk", which has been reviewed by the Trial Safety Review Committee (Committee). In this cohort of normal healthy subjects who received a 100mg dose of VB0004 for 14 consecutive days no significant adverse events were reported. This study group has further enhanced the impressive safety record of VB0004. The interim pharmacokinetics (PK) analysis confirms again that
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.