Results affirm the advantages of Prota's remission peanut OIT
treatments, which lead to significant and sustained benefits
including substantially improved Health Related Quality of
Life
- Study underscores the need to aim for remission as the optimal
treatment outcome.
- Highlights significant long-term benefits provided by two
high-dose peanut oral immunotherapy treatments that induce
remission of allergy.
MELBOURNE, Australia, Aug. 14,
2024 /PRNewswire/ -- Prota Therapeutics Pty Ltd
(Prota), an Australian clinical-stage biotechnology company focused
on the development of novel oral immunotherapy treatments that
induce remission of allergy, today announced publication in the
journal Allergy of the first long-term study directly
comparing remission and desensitization endpoints following
food allergen oral immunotherapy (OIT). The Phase
2b follow-on study also reports
2-year post-treatment outcomes for Prota's remission-inducing
high-dose peanut oral immunotherapies: PRT120, a standalone
high-dose OIT, and PRT100, a probiotic OIT combination treatment,
which were previously shown to induce remission of peanut allergy
in 51% and 46% of treated patients, respectively.
The PPOIT-003LT study, a continuation of the Phase 2b PPOIT-003 randomized, multi-center trial,
provides significant insights into the long-term outcomes of
children who received one of two remission-inducing high-dose
peanut oral immunotherapies: a Peanut Oral Immunotherapy on its own
(OIT) or a combined Probiotic Peanut Oral Immunotherapy (PPOIT).
The study directly compared the long-term benefits and risks
associated with the different treatment outcomes -- remission,
desensitization and allergy, and also reported long-term outcomes
for OIT and PPOIT compared to placebo.
Findings validate remission as a preferred outcome to
desensitization. Participants who achieved remission following
treatment were able to stop treatment and safely consume peanuts
freely. At two years after completing treatment, remission
participants reported fewer peanut ingestion reactions, with no
moderate or severe reactions, no rescue epinephrine injector use,
and most importantly, significantly greater improvement in quality
of life compared to participants who only achieved
desensitization.
Participants who were only desensitized had difficulty
maintaining their required daily peanut ingestion dose and
continued to report severe reactions that required rescue
epinephrine treatment. They did not experience any improvement in
quality of life compared to the allergic group.
Findings also confirmed that both the high-dose OIT (PRT120) and
the combination PPOIT (PRT100) treatments provide lasting benefits
that persist or are improved upon during the 2-year period after
stopping treatment. At 2-years after completing treatment with
either PRT120 or PRT100, children experienced fewer reactions over
time, and continued to enjoy significantly improved health related
quality of life (HRQOL) compared to the placebo group.
Key Findings
- A standalone high-dose peanut oral immunotherapy (OIT) and a
combination probiotic high-dose peanut oral immunotherapy (PPOIT)
that induced remission of peanut allergy in 51% and 46% of treated
patients, respectively, were shown to provide lasting benefits at
2-years after treatment, including significantly improved quality
of life compared with placebo-treated patients.
- Participants with remission were half as likely to have an
allergic reaction to peanut compared with desensitized patients
(15.9% in the remission group, 36.8% in the desensitized
group).
- In the 2nd-year after treatment, remission participants had no
moderate or severe reactions and no rescue epinephrine use; whereas
24% of reactions in desensitized participants were moderate or
severe, and 14.3% of desensitized participants required rescue
epinephrine to treat reactions.
- Participants who achieved remission reported substantial and
clinically meaningful improvement in health-related quality of life
(HRQOL) compared with both desensitized participants and those who
remained allergic; whereas participants who were only desensitized
(without remission) showed no improvement in HRQOL compared with
allergic participants.
Study Design
- Participants: 151 of the 176 (86%) eligible children
aged 1-10 with confirmed peanut allergy who completed the Phase
2b PPOIT-003 randomized trial.
- Study endpoints: Comparison of long-term outcomes by
clinical allergy status: remission, desensitization (without
remission) and persistent allergy; comparison of long-term outcomes
by treatment group: High-dose peanut oral immunotherapy (OIT),
Probiotic Peanut Oral Immunotherapy (PPOIT), and placebo.
- Outcomes Measured: Peanut ingestion, reactions, and
health-related quality of life (HRQOL) at 1-year and 2-years after
treatment.
Summary
The follow-on study, PPOIT-003LT, showed two key findings:
- Remission is a demonstrably better outcome for patients than
only being desensitized or remaining allergic. Remission
participants reported fewer and milder allergic reactions to peanut
(with no requirement for rescue epinephrine) compared to
desensitized patients and, most importantly, experienced
substantially better quality of life compared to both desensitized
and allergic participants.
- The clinical benefits of both the high-dose OIT (Prota's lead
product, PRT120) and PPOIT are sustained or even improved upon in
the long-term, with continuing reductions in reactions to peanut
over time, particularly for remission participants, and lasting
quality of life improvements compared with placebo treatment.
Among benefits of achieving remission
- Freedom from ongoing treatment.
- Reduction in allergic reactions, and in severity of
reactions.
- Substantial HRQOL improvements.
- Positive attitudes toward peanut consumption.
- Psychological benefits including reduced anxiety.
According to the study Principal Investigator, Paxton Loke,
Ph.D., Research Clinician in the Allergy Immunology group at the
Murdoch Children's Research Institute (MCRI), "Remission offers a
more favorable long-term outcome in terms of reduced reactions and
improved quality of life compared to desensitization without
remission or persistent allergy. This study underscores the need to
aim for remission as the optimal clinical outcome."
"The findings from the PPOIT-003LT study highlight the
significant benefits of achieving remission through PRT120
treatment, a high-dose rapid escalation oral immunotherapy for
peanut allergies," said Lead Investigator Professor Mimi Tang, Ph.D., Director of the Allergy
Translation Centre and Head of Allergy Immunology at the Murdoch
Children's Research Institute (MCRI), and CEO of Prota
Therapeutics.
About Prota Therapeutics
Prota Therapeutics is an
Australian proprietary limited late clinical-stage biotech
company dedicated to advancing allergen oral immunotherapies for
treating food allergies, particularly addressing the prevalent and
potentially life-threatening issue of peanut allergy.
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
Murdoch Children's Research Institute (MCRI). For more information
please visit: https://protatherapeutics.com/.
About Murdoch Children's Research Institute
Murdoch
Children's Research Institute is the largest child health research
institute in Australia committed
to making discoveries and developing treatments to improve child
and adolescent health in Australia
and around the world. They are pioneering new treatments, trialling
better vaccines and improving ways of diagnosing and helping sick
babies, children and adolescents. It is one of the only research
institutes in Australia to offer
genetic testing to find answers for families of children with
previously undiagnosed conditions.
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SOURCE Prota Therapeutics