Vectus Biosystems moves to phase 1b in drug trial to treat fibrosis and hypertension
Vectus Biosystems has completed phase 1a of its first in-human trial of its lead drug VB0004.
Biotechnology company Vectus Biosystems (ASX: VBS) has announced the completion of its phase 1a study of lead drug candidate VB0004 to treat fibrosis and hypertension.
It had been the company’s first in-human trial to evaluate the safety, tolerability, and pharmacokinetics of single and repeated doses of the drug in healthy volunteers, as well as patients with mild to moderate hypertension (high blood pressure) with low cardiovascular risk.
The company confirmed on Wednesday the completion of the third and last of its three planned cohorts in the multiple ascending dose segment of the trial, with no significant adverse events reported.
According to Vectus, this final study group “enhanced the impressive safety record” of VB0004, with the data reinforcing previous evidence that the drug 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 Trial Safety Review Committee has now given permission for the phase 1b section of the trial to commence. In this segment, patients with uncomplicated hypertension will be treated for 28 days at a daily dose of 30 milligrams of VB0004.
Potentially transformational treatment
Vectus chairman Dr Ronald Shnier described the completion of phase 1a as a significant milestone in proving the safety of the antifibrotic/antihypertensive drug.
“This is particularly pleasing as we move towards the next phase of testing of a compound that can have a significant and widespread global positive impact on disease, the pathology of which has many aetiologies,” he said.
Fibrosis is the replacement of functioning tissue in organs such as the heart, lungs, kidneys, liver among others by scar tissue resulting in a loss of function.
Data from the World Health Organization (WHO) indicates that fibrosis plays a role in more than 40% of deaths worldwide.