Healthy Habits: Peanut Allergy Research with Prota Therapeutics

 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.

You can read the full release here. I also had a chance to learn more in this interview with Dr. Mimi Tang, CEO of Prota Therapeutics.

1. Can you share the difference between remission and desensitization when it comes to peanut allergies?

• Desensitisation refers to a temporary increase in the amount of peanut you can tolerate before reacting. This provides some comfort to patients and families in terms of gaining protection against trace amounts of cross contamination with peanut. However drawbacks of desensitisation are: 1)  protection is only temporary, so the patient must continue on daily treatment (indefinitely); 2) the underlying allergy is not addressed so patients must still follow a strict peanut avoidance diet; 3) studies to date have failed to show that desensitisation leads to an improvement in quality of life when compared with current standard care (allergen avoidance/placebo treatment).
• Remission is when there is no clinical evidence of peanut allergy (ie the patient passess a standard diagnostic peanut challenge, meaning we cant show evidence of clinical peanut allergy) after treatment has been stopped for weeks or months. Remission provides a longer-lasting protection because the underlying allergic response to peanut has been redirected towards tolerance. Benefits of remission for the patient and their families include: 1) the patient can stop treatment, 2) there is no longer a need to avoid peanut, removing the lifestyle restrictions of an avoidance diet, and 3) patients have the choice to eat peanut as part of their diet if they wish, 4) studies suggested that remission leads to a substantial and lasting improvement in quality of life compared with standard care (placebo / allergen avoidance).

• You might be interested in a podcast that I recorded a couple of months ago – it discusses the different outcomes of desensitisation and remission - Nuts for life podcast https://www.nutsforlife.com.au/resource/episode-16-peanut-allergy-trial/

 

2. What implications does this study have for families of kids with allergies?
• PRT120, a novel high dose, rapid escalation peanut oral immunotherapy, offers kids with peanut allergy and their families the ability to gain remission of their peanut allergy, allowing them stop avoiding peanut and eat peanut freely, without any ongoing treatment.
• PRT120 is the first food allergy treatment in development that has been shown to provide a significant improvement in quality of life compared with standard care (allergen avoidance/placebo treatment). This is a very important outcome because reduced quality of life is the main burden that children and families affected by food allergy have to live with.

 

Key takeaways from the study:  

• PRT120 induced remission of peanut allergy in 51% of treated patients, and full desensitisation (to around a serve of peanut) in a further 23% of treated patients.
• Children in remission were able to stop treatment and eat peanut safely in the 12 months post-treatment. Children who were only desensitised (without achieving remission) gained protection against around a serve of peanut while they remained on daily treatment.
• PRT120 led to a substantial and lasting improvement in quality of life compared with standard care
• This is the first study to compare the risks / benefits associated with the different clinical outcomes of desensitisation, remission and persistent allergy following peanut OIT. Findings highlight that remission is a better outcome for patients than desensitisation alone (without remission)
• Children with remission had fewer reactions than children who were only desensitised (without achieving remission)          
• Children in remission had significantly greater improvement in quality of life compared with children who were only desensitised
• Children with remission also had significantly better quality of life compared with children who remained allergic

 

3. What are the next steps that you hope to see coming out of this research?

• Prota will advance the development of PRT120 so it can be available to all children with peanut allergy
• PRT120 will be the first remission drug for treatment of food allergy
• Prota is raising capital to take PRT120 to the next stage of development , which is to be ready for a large phase 3 clinical trial in the US

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/.