Melbourne biotech startup Prota Therapeutics has raised US$21 million (A$32m) ahead of a Phase 3 clinical trial for its oral therapy treatment for peanut allergy.
The round, a combination of equity and debt financing, was led by Singapore-based SPRIM Global Investments (SGI). Australian VC OneVentures was an early backer of the biotech and one of its largest shareholders via the OneVentures Healthcare Fund III.
Founded in 2016 to develop and commercialise novel oral immunotherapy treatments for food allergy, Prota’s first product addresses an market expected to be worth US$1 billion by 2030, and growing by 10% annually, in part due to the increasing incidence of peanut allergy globally.
The funds will go towards the chemistry, manufacturing, and controls (CMC), and regulatory path to an Investigational New Drug (IND) application the company expects to submit in the next 15 months.
A Phase 2b clinical trial for the treatment, called PRT-120, was hosted by the Murdoch Children’s Research Institute (MCRI) in 2022 and indicated that Prota’s high dose, rapid escalation dosing regimen to be highly successful in inducing clinical remission of peanut allergy in children and, more importantly, leading to significant and clinically meaningful improvement in quality of life of patients.
The long-term follow-up data from the trial further showed that children in remission have fewer reactions, less rescue epinephrine use, and far greater improvement in quality of life than children who are only desensitised, validating remission as the patient-preferred outcome.
The Phase 3 trial is expected to take place in the US and Australia.
Prota’s technology is based on over 15 years of research led by Professor Mimi Tang at the MCRI.
“Our Phase 2b multicentre randomised controlled trial conducted by MCRI showed that PRT120 is highly effective at inducing remission of allergy, and more importantly, leads to significant and clinically meaningful improvement in quality of life, compared with standard care (placebo treatment),” Professor Tang said.
“Long-term follow-up data further shows that children in remission have fewer reactions, less rescue epinephrine use, and far greater improvement in quality of life than children who are only desensitized, validating remission as the patient-preferred outcome.”
OneVentures founding partner Dr Paul Kelly said the investment deal in the current market validates the potential of Prof Tang’s technology in the face of a persistent unmet need.
“Prota’s treatment offers the promise of an induction of remission of allergy, allowing patients to eat peanuts freely and enjoy an improved quality of life,” he said.