Vectus Biosystems Limited announced that the second 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", has been reviewed by the Trial Safety Review Committee (Committee). In this cohort, which received a 30mg dose of VB0004 for 14 consecutive days, no significant adverse events were reported, adding again to the impressive safety record of VB0004. The interim PK analysis confirmed that the time to achieve the maximal concentration (Tmax) of VB0004 occurred six to eight hours after dosing, and the plasma half-life (the time taken for the plasma concentration of VB0004 to decrease by 50%) was between 10 and 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, adding to the safety profile of VB0004. This data provides further 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 two of the three planned M.A.D. cohorts. The study 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 and 30mg administered daily over a 14-day period. Also established are the consistent 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 third and final M.A.D. cohort to proceed, in which participants will receive 100mg per day for 14 days. Four participants have been enrolled and commenced the 14-day study.