• Groundbreaking New Clinical Trial Data Published in The Lancet Child & Adolescent Health
• Data shows that 51% of participants achieved sustained unresponsiveness (clinical remission) to peanut after 18 months of treatment
• Prota Therapeutics announces new round of capital raising for further P3 clinical investigation and global commercialization of its PRT120 OIT

MELBOURNE, Australia, Feb. 9, 2022 /PRNewswire/ -- Prota Therapeutics, an Australian biotechnology company focused on the development of novel oral immunotherapy treatments, has achieved a significant milestone in the treatment of peanut allergy in children. Published in The Lancet Child & Adolescent Health^[1], a highly regarded peer-reviewed medical journal, the Phase 2b clinical trial results validate Prota's lead product candidate PRT120. PRT120 is an investigational oral immunotherapy with a novel high dose, rapid escalation dosing regimen for the treatment of peanut allergy. The placebo-controlled trial confirms the effectiveness of PRT120 comprising Prota's rapid escalation dosing regimen in inducing clinical remission of peanut allergy in children and improving quality of life for patients.

The randomized controlled trial was designed to analyze the effect of an oral immunotherapy (the gradual introduction of the allergenic food) delivered via a proprietary, high dose, rapid dose escalation schedule, versus an oral immunotherapy delivered in the same way together with a probiotic in the treatment of children with peanut allergy. The researchers found that about half of children that received either type of treatment achieved remission, allowing them to stop treatment altogether and safely eat peanut freely.

The research was led by Murdoch Children's Research Institute (MCRI) with Professor Mimi Tang, CEO of Prota Therapeutics, as one of the Lead Investigators. The randomised controlled trial was conducted at The Royal Children's Hospital in Melbourne, Perth Children's Hospital, and the Women's and Children's Hospital in Adelaide, involving 201 children aged between 1-10 years. The trial was staged over four years, with participants followed up to 12 months post-treatment.

Remission of allergy refers to the absence of clinical reactivity that persists after treatment has been stopped for a period of time. This allows patients to stop treatment and no longer adhere to strict allergen avoidance. This contrasts with desensitisation which is a temporary increase in the amount of allergen that causes a reaction for patients that is only maintained with continuing treatment. Desensitisation provides protection against accidental exposure to allergen, however patients must remain on daily treatment and also maintain strict allergen avoidance.

Previous studies of peanut oral immunotherapy have shown limited success at stimulating remission, with only a small subset of patients achieving this endpoint after years of treatment. In this new trial, 51% of children achieved remission after 18 months, compared to 5% in the placebo arm, recording the highest rate of remission yet reported for a standalone peanut oral immunotherapy treatment in school-aged children.

The study used Prota's novel dosing regimen comprising a proprietary rapid escalation, high dose approach which researchers believe contributed to the remission rates being higher than previous oral immunotherapy trials, alongside other factors including the younger age of subjects.

Professor Mimi Tang, CEO of Prota Therapeutics and Lead Researcher at MCRI says: "This is an exciting time for our company with the publication of these remarkable results. It is the first randomized controlled study of peanut oral immunotherapy to show high rates of sustained unresponsiveness in school-aged children and the first to show that a peanut allergy treatment can provide substantial improvement in quality of life compared to current standard care of peanut avoidance. We are especially gratified by the strong improvement in quality of life for these children and will continue our path to bring this treatment to patients."

Dr Paul Kelly, Founding Partner of OneVentures, one of Prota's lead shareholders, comments "We recognize that peanut allergy is a growing health concern with an increasing number of patients affected every year. We are very proud to support Prota as they strive further ahead to improve the lives of peanut-allergic patients and their families through innovative solutions. This company has the potential to transform the way peanut allergy is treated and we are excited to see it flourish."

Prota Therapeutics is looking to raise funds to support the further clinical development and commercialization of PRT120. The company's food immunotherapy technology was developed at the Murdoch Children's Research Institute (MCRI), which led the four-year research study that validated its efficacy. Founded in 2016, privately-held Prota Therapeutics has leading Australian venture capital investment firm OneVentures as largest shareholders, supporting its clinical program and commercialization.

The paediatric peanut allergy market is estimated to be worth $3 billion by 2027, with around 1.1 million patients between the ages of 1-17 diagnosed in the US alone last year[1]. This presents a significant opportunity for Prota Therapeutics to bring PRT120 to market, providing a highly differentiated long-lasting treatment that offers meaningful improvements to the quality of life of patients and their families.

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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/^[2] 

About OneVentures

OneVentures is one of Australia's leading venture capital firms, with over $500M in funds under management. But we do more than invest. We take companies to that all important next stage, by actively shaping their future. We apply our years of international experience, operational and executional expertise to accelerate the growth of our portfolio companies.

A global growth focus drives our investment selection with our current portfolio including companies with truly innovative products tackling multi-billion-dollar problems, from needle-free vaccinations to virtual communications to adaptive e-learning.

Game changers, that deliver lasting gains.

Learn more at www.one-ventures.com^[3].

About OneVentures Healthcare Fund III

In December 2016 OneVentures launched its $170M Healthcare Fund III, a licensee of the Australian Government Biomedical Translation Fund. OneVentures Healthcare Fund invests in therapeutics, devices and diagnostics at or near clinical development with a clear commercial, regulatory and reimbursement pathway; and well-defined value inflection and exit points on deal entry.

The Fund will invest $10 to $20 million per company in Australian domiciled companies. The OneVentures team will provide support to drive these opportunities through the clinical, regulatory and reimbursement processes to achieve prominence in global markets.

Learn more at www.one-ventures.com.au/funds^[4] 

[1] Globaldata Peanut Allergy: Epidemiology Forecast to 2027^[5]

View original content to download multimedia:https://www.prnewswire.com/news-releases/prota-therapeutics-achieves-peanut-allergy-treatment-milestone-groundbreaking-clinical-trial-data-demonstrates-clinical-remission-of-peanut-allergy-in-paediatric-patients-301478382.html^[6]

References

1. ^{^} The Lancet Child & Adolescent Health (www.thelancet.com)
2. ^{^} https://protatherapeutics.com/ (protatherapeutics.com)
3. ^{^} www.one-ventures.com (www.one-ventures.com)
4. ^{^} www.one-ventures.com.au/funds (www.one-ventures.com.au)
5. ^{^} Globaldata Peanut Allergy: Epidemiology Forecast to 2027 (store.globaldata.com)
6. ^{^} https://www.prnewswire.com/news-releases/prota-therapeutics-achieves-peanut-allergy-treatment-milestone-groundbreaking-clinical-trial-data-demonstrates-clinical-remission-of-peanut-allergy-in-paediatric-patients-301478382.html (www.prnewswire.com)