SFI: Shortening the odds for transplant patients
Innovation Profile Three Trinity professors got major funding for a drug that could reduce rejection in kidney transplants
Prof Luke O’Neill, Trinity College Dublin. Photograph: Alan Betson
A new drug which could significantly reduce the chances of rejection by kidney transplant patients has been developed by Irish biotech company Opsona Therapeutics and is about to enter phase-two clinical trials. The trial could result in the drug being approved for use in patients within the next two years and follows a successful fundraising round of €33 million from a consortium of 10 investors.
“It took about a year to secure this latest investment,” says Luke O’Neill. “It was very much a triple-act between me and the other two founders. I must have made more than 50 presentations before we finally got the whole thing together. It was a very complicated deal involving 10 different venture capital funds.”
O’Neill and Opsona have been engaged in research into proteins known as toll-like receptors (TLRs) for many years. These play a significant role in inflammatory conditions like rheumatoid arthritis and are also involved in the process that leads to the kidney transplant rejection.
“What we are doing addresses a very real need”, O’Neill explains. “Where you have a living donor who is a relative and a good match there is a very good chance of the transplant taking and not being rejected. However, in other cases where the kidney does not come from a live donor there is a 40 per cent chance of rejection.
“Dialysis is a horrible treatment for a patient and is a great burden on the health system. We believe there is a good possibility that our treatment could reduce the rejection rate by half and with more than 2,000 patients awaiting transplants in Europe at any one time this would be very significant.”
This latest trial is being carried out in 52 hospitals in the US and Europe and is a two-part multi-centred, double-blinded and placebo-controlled clinical study to evaluate the safety, tolerability and efficacy of the new product in renal transplant patients at high risk of rejection.
A phase-one clinical trial in healthy human volunteers has already proved successful while what is known as a “phase zero” study in a small number of patients who have had transplants has demonstrated the safety of the drug. “The trial will cost around €19 million and will take around a year and a half to complete,” O’Neill adds. “We’ll know then if it has been a success or not. This is what I call the ‘man-from-Del-Monte moment’ when we get the news if it will be approved.”
The science behind the drug is no less interesting than its potential as a treatment. There are 10 types of toll-like receptor and Opsona is targeting one of them: TLR2.