Vectus Biosystems Limited announced that all five of the planned cohorts in the Single Ascending Dose (S.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", have been reviewed by the Trial Safety Review Committee (Committee). The results of the 2mg, 10mg, 30mg, 100mg and 300mg doses of VB0004 have now been reviewed by the Committee. Of greatest significance, no adverse events have been observed at any of the five doses of VB0004 studied to-date.

Further, the latest dose of 300mg has added very significantly to the therapeutic safety margin for VB0004. The interim pharmacokinetic (PK) analysis confirmed that the time to achieve its maximal concentration (Tmax) after dosing occurred at six to eight hours and the plasma half-life (the time taken for the plasma concentration of VB0004 to decrease by 50%) was 17 to 17.5 hours. This preliminary 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.

The Committee also reviewed the outcomes for the first Multiple Ascending Dose (M.A.D.) cohort in which 10mg of VB0004 was administered daily for 14 days. Again, there were no adverse events adding to the impressive safety profile of VB0004. The Committee has now given permission for the second M.A.D. cohort to proceed and the first three participants have been enrolled.