Allergy immunotherapy company Prota Therapeutics Pty Ltd (Prota), is pleased to announce it has partnered with Chr. Hansen, a leading global bioscience company, to manufacture and supply pharmaceutical quality LGG®1 probiotic strain, Lactobacillus rhamnosus, initially for the treatment of peanut allergy.
Approximately 220-250 million people globally suffer from food allergies, an increase of 350 per cent over the past 20 years. The economic impact for treatment of food allergies in the US has been estimated at US$24.8 billion per year.2
Peanut allergy is the most common cause of anaphylaxis, a life-threatening allergic reaction, and one of the most common causes of death from food allergy. More than three million Americans suffer from peanut allergy3 resulting in a global peanut allergy therapeutics market estimated to reach more than US$10 billion by 2025.4
Prota Therapeutics is pioneering a new form of oral immunotherapy to treat food allergies, with its patented probiotic and peanut oral immunotherapy (PPOIT) treatment licensed from the Murdoch Children’s Research Institute (MCRI). Treatment will combine Chr. Hansen’s specifically formulated pharmaceutical quality LGG® probiotic strain, Lactobacillus rhamnosus, with targeted doses of proprietary formulations of peanut protein. The treatment is designed to reprogram the immune system’s response to peanuts and eventually develop tolerance.
Leveraging Chr. Hansen’s manufacturing and microbial solutions expertise
Building upon earlier trials conducted at the Murdoch Children’s Research Institute, Prota Therapeutics is progressing towards a large-scale Phase III clinical trial, under a US Investigational New Drug Application (IND). The aim is to commercialize a medicinal product using new pharmaceutical grade therapeutic dosage forms for treating peanut allergy as the first indication, and to build on the relationship with Chr. Hansen to explore indications for treating other food allergies.
“An effective therapy to treat peanut allergies is now a realistic target. Chr. Hansen is the ideal partner for us, both as the owner of one of the key components in the therapeutic product – LGG® – and as a leading expert in microbial solutions. Chr. Hansen has demonstrated the capability to deliver a pharmaceutical quality product that can be regulated as a biological therapeutic product. Together with our proprietary peanut protein formulation, we aim to take this combination product through a Phase III clinical trial to commercialization of a treatment for peanut allergies,” says Dr. Suzanne Lipe, CEO at Prota Therapeutics.
Unlocking the potential of good bacteria
Numerous studies have highlighted the therapeutic potential of specific bacteria in preventing and treating metabolic, gastrointestinal and other diseases. Investigating specific bacteria for the treatment of food allergies is an area that has recently gained momentum.
Having produced LGG® for more than 10 years before fully acquiring LGG® from Valio in 2016, this new partnership is an example of how Chr. Hansen’s focus on industry leading product quality and clinical documentation can expand the potential of the probiotic strain, LGG® into a new breakthrough area.
Christian Barker, Executive Vice President, Health & Nutrition at Chr. Hansen says:
“Chr. Hansen has the ability to maximize the value of a probiotic strain through our deep experience in microbial process development and formulation, our focus on quality, and our global reach. The partnership with Prota Therapeutics is part of our strategy to become the partner of choice for companies wanting to develop new generations of therapeutic microbes.”
Chr. Hansen brings the world’s best documented probiotic strain to the partnership
Lactobacillus rhamnosus is the best documented probiotic strain in the world. It has been used in food, dietary supplements and infant nutrition since 1990 and has shown beneficial effects on the gastrointestinal and immune system. It is supported by more than 300 clinical studies and 1,200 scientific publications.
Paradigm shift in management of food allergy
As previously reported after publication of 4 year follow up data, Prota’s products aim to provide sustained long-term effects and the ability to include peanut in the diet, rather than using therapy to merely protect against accidental ingestion. “For the first time, we could have products on the market that provide meaningful and long-lasting treatment benefits, which allow sufferers to eat peanut products without thinking about it, as part of a regular diet just like unaffected people” said Dr. Suzanne Lipe.
“Our partnership with Chr. Hansen could see us extending this treatment approach for other food allergies, opening a potential pipeline of products for the company.”
1 LGG® is a trademark of Chr. Hansen
2 Gupta R et. al., JAMA Pediatrics 2013; 167(11):1026-103
3 Sicherer et. al., J Allergy Clin Immunol 2010;125:1322-6
4 DelveInsight, “Peanut Allergy – Competitive Landscape, Market Insights, Epidemiology and Market Forecast-2025”