First Company to Validate Significant Quality of Life Improvements Compared with Standard Care
Children’s ability to eat peanut freely and safely delivers meaningful improvement in quality of life for families and patients
MELBOURNE, Australia, May 16, 2022 /PRNewswire/ — Prota Therapeutics Pty Ltd, an Australian biotechnology company developing novel oral immunotherapies for peanut allergies, is the first company to validate significant Health-Related Quality of Life improvements (HRQL), when compared to placebo, in a Phase 2b clinical trial of oral immunotherapy PRT120, in which 51 percent of treated children aged 1-10 years achieved clinical remission (Lancet, 2022). As importantly, PRT120 treatment led to a significant and substantial improvement in quality of life for children and their families.
Children and families affected by food allergy suffer severely reduced quality of life due to lifestyle restrictions imposed by the need for allergen avoidance and the unpredictability of potentially life-threatening reactions.
“Stella’s quality of life has improved considerably,” said Ju Lee Ng, whose daughter was among the 51% of children who achieved remission. “After treatment we were able to travel and enjoy an amazing holiday without the fear and stress of experiencing an allergic reaction. As well, her level of anxiety is dramatically lower. The burden to always check food labels for peanuts or brief her teachers or friends’ parents was removed.”
A report by the Institute for Clinical and Economic Review (ICER) cited improving quality of life for both the patient and caregivers as an important goal of treating peanut allergies. Recognizing the importance of health-related quality of life improvements as a clinically meaningful endpoint, Prota prioritized, measured and validated this treatment outcome in its clinical trials.
The researchers, at the Murdoch Children’s Research Institute (MCRI) in Melbourne, Perth Children’s Hospital, and the Women’s and Children’s Hospital in Adelaide, were the first to show significant quality of life improvement following treatment compared with placebo (standard care) in a large, randomized, placebo-controlled peanut allergy trial. The PRT120-treated group achieved clinically meaningful improvements in quality of life compared with the placebo group at 12-months post-treatment (p= 0.002).
Food allergy quality of life expert Matthew Greenhawt, M.D., Director, Food Challenge and Research Unit at Children’s Hospital Colorado, noted that these results are exceptionally promising. “Families seeking peanut allergy treatment have expressed a desire for protection against peanut ingestion that has meaningful impact, in that socialization can be enhanced and the burden of avoidance can be relieved, leading to a restoration of normalcy. The high number of children in this trial able to regularly incorporate peanut into the diet ad libitum represents such a highly meaningful target, and I think is well reflected in their improvement in quality of life.” Dr. Greenhawt was not involved in the clinical trial design or conduct but is a member of Prota’s scientific advisory board.
Children who achieved remission were able to stop treatment and introduce peanut into their diet, no longer having to follow strict peanut avoidance, which the researchers believe were key to improving quality of life. The group achieving desensitization only did not have such quality-of-life improvement.
“Improving quality of life is the most meaningful outcome for peanut allergy patients. We are very pleased to have shown such meaningful improvement in quality of life compared with standard care, exceeding minimum clinically important quality of life differences,” said Lead Investigator Professor Mimi Tang, Ph.D., Head of the Allergy Immunology Group at MCRI. “As well, this is the first treatment that offers a solution for every child with peanut allergy, whether they react to tiny or large amounts of peanut. This is important because all children with peanut allergy live with lifestyle restrictions, fear and anxiety caused by current management, and can benefit from treatment.”
About Prota Therapeutics
Prota Therapeutics is an Australian, proprietary limited, privately-held biotech company established in 2016 to develop and commercialize novel oral immunotherapy treatments. Prota holds an exclusive license to the proprietary food immunotherapy technology developed at the MCRI. The company is, in part, a OneVenture’s Healthcare Fund III investment. This fund was established with investment in part from the Australian Commonwealth Government through the BioMedical Translation Fund initiative. Prota Therapeutics has its headquarters in Melbourne, Australia. More information: https://protatherapeutics.com/.