Infensa Bioscience doses first patient in a Phase 1 trial of IB409 for cardiovascular diseases
Infensa Bioscience Pty Ltd today announced it has dosed the first patient in a Phase 1 clinical trial with IB409, a novel therapeutic for treating cardiovascular diseases.
Cardiovascular diseases are the leading cause of death worldwide, responsible for 20.5 million fatalities in 2021. Heart attack and stroke account for the majority, causing 17 million – or 27 per cent – of global deaths.
Current standard-of-care therapies for heart attack and stroke focus only on restoring blood flow, leaving significant unmet needs as they do not prevent tissue damage caused by both loss of oxygen (ischemia) due to blockage of a coronary artery or by restoration of blood flow (reperfusion) when the blockage is treated. IB409 is a first-in-class therapeutic designed to fill these critical treatment gaps by protecting against both types of tissue injury – ischemic and reperfusion.
Infensa’s Chief Executive Officer, Mark Smythe, said, “We are delighted to announce the first dosing of IB409, marking Infensa’s transition from an early-stage to a clinical-stage company, a significant milestone in our trajectory. I extend our gratitude to the volunteers, Infensa staff and other investigators who have made possible the trial of this potential first-in-class treatment for heart attack and stroke.”
The Phase 1 clinical trial is a first-in-human study that will assess the safety, tolerability, dosage and pharmacokinetics of IB409.
Professor Glenn King, Infensa’s Chief Scientific Officer, said the drug candidate was based on research from his team at The University of Queensland’s Institute for Molecular Bioscience that isolated a novel peptide, Hi1a, from the venom of an Australian funnel-web spider.
“The development of Hi1a was underscored by exceptionally promising preclinical data published in world-leading scientific journals, with the Infensa team transforming the spider-venom peptide into IB409, a miniaturised peptide suitable for drug development,” King said.
Chair of the Infensa Bioscience Board, Ananth Siva, said the company is guided by a seasoned management team and board of directors, with extensive experience in biotechnology and pharmaceutical development.
“Our CEO Mark Smythe has a proven track record founding peptide-based therapeutic companies and advancing them through clinical development. IB409 represents his seventh peptide therapeutic to enter clinical trials. Mark is the founder and a previous Executive of Protagonist Therapeutics, a NASDAQ-listed company currently worth AUD7.5 billion,” Siva said
“Our Chief Development Officer Michael Ankersen has guided clinical trials at prominent international pharma companies and is responsible for two drugs on the market, one to treat diabetes and a therapeutic for cancer side effects.”
The Phase 1 trial is funded by $17.8 million from the Australian Government’s Medical Research Future Fund MRFF, and $250,000 in philanthropic funds raised by the Victor Chang Cardiac Research Institute (VCCRI) and St Vincent’s Hospital, Sydney. Infensa’s $23 million Series A raise – one of the largest in Australia – has also been instrumental in enabling this milestone.
The MRFF project involves researchers from UQ’s Institute for Molecular Bioscience, VCCRI, Monash University, the Baker Heart & Diabetes Institute, St Vincent’s Hospital, the Alfred Hospital in Melbourne, and The Prince Charles Hospital in Brisbane.