Vectus Biosystems progresses clinical trials of drug VB0004 for treating fibrosis and hypertension
Phase 1a clinical trials of VB0004 generated an “impressive safety profile”, and will underpin a phase 1b study.
Fibrotic diseases specialist Vectus Biosystems (ASX: VBS) has confirmed that it will move to the next phase of testing of its lead drug for treating fibrosis and hypertension.
In its September quarter report, the company says phase 1a clinical trials to date have established an “impressive safety profile” for the drug candidate VB0004, with consistent pharmacokinetics (drug absorption, distribution, metabolism, and excretion).
The phase 1a human clinical trials were completed in September, across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts
A trial safety review committee reviewed data from all five SAD, as well as all three MAD cohorts.
The trial achieved a maximum tolerated single dose of 300 milligrams, with no significant adverse events seen in MAD studies at 10mg, 30mg or 100mg (administered daily over a 14-day period).
The trial also established consistent pharmacokinetics of six-to-eight hours to achieve maximal plasma concentration and a half life in excess of 10 hours.
‘Significant milestone’
“This is a significant milestone in proving the safety of the company’s antifibrotic/ antihypertensive drug,” Vectus stated.
Vectus hopes the data provide more 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.
“This is particularly pleasing as Vectus moves towards the next phase of testing of its compound that can have a significant and widespread global positive impact on disease, the pathology of which has many aetiologies .”
Upcoming trials
Vectus is now moving to first-in-human, phase 1b trials of VB-0004 on patients with mild to moderate hypertension with low cardio-vascular risk.
From a drug ‘library’ of 1,000 compounds, Vectus has also selected potential candidates for liver fibrosis (VB4-A32) and lung fibrosis (VB4-A79).
The company also hopes that VB0004 will be able to repair fibrotic damage resulting from COVID-19.
Accugen technology
During the quarter, Vectus continued its work on the development program in food safety and diagnostic testing using its Accugen technology, “which is a large and growing market”.
Consisting of AccuCal™ and RealCount™ software, this technology aims to improve the speed and accuracy of measuring the amount of DNA and RNA in samples tested in laboratories.
Funding
The company reported cash on hand of $952,000 as of 30 September, with cash burn of $325,000.
Expenses were largely related to the VB0004 trial costs.
In late September, Vectus issued just over 10.98 million fully paid ordinary shares, following the conversion of all remaining convertible notes – 9.62 million in all – at a conversion price of $0.50 per note.
The 22 note holders also elected to have the accumulated interest paid by way of 1,361,736 shares.
In July 2022, the company also received a $936,000 research and development tax refund from the Australian Taxation Office, relating to the year ended 30 June 2021.
The company expects a further refund of $1.3 million in the June quarter of 2023.
Vectus also reports “a number of discussions underway that are expected to result in additional funding for the company.”
Vectus background
Following a $5.1 million initial public offer, Vectus listed on the ASX in February 2016.
The company was founded in 2005 by Maurie Stang and hypertension expert Dr Karen Duggan.
Mr Stang is also chairman of – and a driving force behind – the ASX-listed Nanosonics (ASX: NAN), now a global leader in surgical probe sterilisation.