Vectus Biosystems unveils more promising results from phase 1 clinical trial

Ahead of enticing pharmaceutical partners, Vectus Biosystems (ASX: VBS) is confident that positive results will continue to flow from the ongoing phase 1 trial of its lead drug VB0004 which treats fibrosis and high blood pressure.

The biotechnology company has developed its lead compound VB0004 as a treatment for hypertension (high blood pressure) and fibrosis (the replacement of functional tissue by scar tissue) which includes treatment for heart, kidney and liver diseases.

It is currently undertaking its first in-human trial to study the safety, tolerability, and pharmacokinetics of single and repeated doses of the drug in normal human volunteers. Following which two groups of patients with mild to moderate hypertension with low cardiovascular risk will be studied.

In its latest update, the company reported no significant adverse events from the second of three planned cohorts in the multiple ascending dose (MAD) segment of the trial. This news follows previous trial successes including nil reports of adverse events experienced during the single ascending dose (SAD) segment of the study.

Further, this data provides 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.

Earlier this month, the Trial Safety Review Committee gave permission for the third and final MAD cohort to proceed after reviewing data from all five SAD cohorts and the first two of the three planned MAD cohorts. Four participants were enrolled and commenced the study, where they received 100 milligrams per day of VB0004 (or placebo) for 14 days.

Vectus is awaiting the data with high anticipation, believing results so far already place it in a strong position to attract interest from big pharma.

Recent results

The latest results from Vectus’ phase 1/1b single centre, double-blind, randomised, placebo-controlled, dose escalating study demonstrated that a 30mg dose of VB0004 for 14 consecutive days led to no significant adverse events and suggested that little to no accumulation of the drug occurred with time.

In this second MAD cohort, interim pharmacokinetics analysis also confirmed that the time to achieve maximal concentration of VB0004 occurred six to eight hours after dosing and the plasma half-life (the time taken for the drug’s plasma concentration to decrease by 50%) was between 10-15 hours on both days one and 14.

The multiple dosing segment of the study followed the single dose studies undertaken during the first half of the year, which also reported no significant adverse events even at the highest single dose of 300mg of VB0004. Pharmacokinetic analysis from the SAD cohorts revealed similar data as the MAD cohorts (six hours to reach maximal plasma concentration and 10-15 hours for the concentration to reduce by half), providing promising evidence that VB0004 would be amenable to once-daily dosing.

Potentially transformational treatment

Commenting on the earlier single dose results, Vectus chairman Dr Ron Shnier had described VB0004 as a “truly transformational agent” that has the potential to “not just slow down disease progression, but in fact, potentially provide clinical reversal of existing damage”.

Vectus is backed by non-executive director and second largest shareholder Maurie Stang, who is also the chairman for $1.3 billion disinfection device company Nanosonics (ASX: NAN). Mr Stang recently told media that if VB0004 continues down its current path, it would likely be the “largest and most important drug to come out of Australia”.

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.

WHO data indicates that fibrosis plays a role in more than 40% of deaths worldwide.