Sometimes the slow, measured pace of medical research is frustrating. On average it takes about 12 years for a new drug to move from discovery to general practice, but each step towards approval is important as it validates whether or not these new medicines actually work and are safe. A new four-year follow-up study on the efficacy of a probiotic-based peanut allergy cure has revealed the majority of the original participants are still displaying tolerance to peanuts, paving the way for the final phase of trials to bring the treatment to the public.
In 2013, a team at the Murdoch Children's Research Institute in Melbourne, Australia, completed a study involving over 60 children suffering from peanut allergies. Over 18 months the children either received a placebo or a combination of the probiotic Lactobacillus rhamnosus with a peanut protein. At the end of the study 82 percent of the children receiving the probiotic treatment could safely eat peanuts.
"It appears that we have been able to modify the allergic response to peanut such that the immune system produces protective responses rather than a harmful response to the peanut protein," said pioneer of the therapy Professor Mimi Tang, four years ago after the original study was published.
A big question that remained was whether this degree of peanut tolerance would hold over the long term. Now four years later the long-term data is in – and it's extraordinarily positive. Eighty percent of those subjects that were tolerant of peanut by the end of the original study were still regularly eating peanuts years later with no problems.
"These children had been eating peanut freely in their diet without having to follow any particular program of peanut intake in the years after treatment was completed," says Professor Tang of the recent follow-up work.
The research also suggests that a tolerance-based treatment for food allergies could be a realistic and effective target for addressing other food allergies.
The next step for the researchers is to move into Phase III clinical trials, which are often considered the most expensive and time-consuming part of the development process as they involve large patient groups across multiple locations. In the US the FDA can sometime approve treatments to market while they are still undergoing Phase III trials.
The team at the Murdoch Children's Research Institute has already jointly set up a company called Prota Therapeutics with a goal of moving this treatment through to public use as quickly as possible. No specific timeframe has been outlined, but the treatment should be available in the near future and could dramatically change the lives of many people suffering from this dangerous allergy.
The new follow-up study was published in the journal The Lancet Child & Adolescent Health.