“Real-World” Trial Will Augment Ongoing Phase 3 PALISADE Trial to Support Regulatory Filings and Market Understanding
BRISBANE, CA, USA I May 11, 2017 I Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the enrollment of its first patient in the Phase 3 RAMSES (ARC007) clinical trial of AR101 for treatment of peanut allergy. AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.
The Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Age 4-17 Years, or RAMSES (ARC007), trial is designed to gain experience with AR101 in a real-world setting, without the use of a double-blind, placebo-controlled food challenge (DBPCFC) to confirm peanut allergy. It will assess the safety and tolerability of AR101 versus placebo. The trial follows the same up-dosing and maintenance protocol as Aimmune’s ongoing Phase 3 PALISADE trial, taking place in the United States, Canada, and eight countries in Europe.
“The peanut-allergic patients in my practice have been highly motivated to participate in Aimmune’s clinical trials. They’re looking for access to a potential treatment, since peanut allergy patients are at risk for life-threatening anaphylaxis and have to take extra caution with eating. My patients have been happy to have the opportunity to participate in these clinical trials and help with the effort which may lead to an approved product to treat their problem,” said Stanley M. Fineman, M.D., Atlanta Asthma & Allergy. “Not requiring the diagnostic food challenge requirement is more consistent with the way we practice, where the diagnosis of peanut allergy is typically made based on a strong clinical history and corroborating positive skin prick tests and/or elevated blood levels of peanut antibodies.”
RAMSES (ARC007) is a randomized, double-blind, placebo-controlled trial enrolling approximately 440 peanut-allergic patients ages 4–17 at multiple sites in the United States and Canada. Patient selection is based on stringent entry criteria, including a well-documented medical history of IgE-mediated reactions to peanut (including anaphylaxis), skin reactivity, and analyses of peanut-specific allergic antibodies.
The trial will monitor treatment-emergent adverse events during a six-month up-dosing period, and then, after unblinding, follow patients for at least six months on the maintenance dose of 300 mg of AR101 per day. Aimmune anticipates that the absence of an entry food challenge may improve the tolerability profile of AR101 in early stages of dosing by removing exposure to high levels of peanut allergen that may otherwise prime the immune system prior to treatment.
“We’re conducting our RAMSES trial not only to support regulatory filings and real-world market understanding, but also to test whether removing the entry food challenge can lead to improved tolerability of AR101 during early up-dosing. Recent data from our collaborator Dr. Erik Wambre and his colleagues at the Benaroya Research Institute on PALISADE patient samples support the idea that the food challenge may activate the immune system and thus increase the risk of additional allergic reactions in the early up-dosing period that follows,” said Aimmune CMO, Daniel Adelman, M.D. “Also, while some studies1,2 have shown that food allergy patients and caregivers report improvements in quality of life following food challenges, regardless of outcome, the process can be emotionally tough. We’ve been hearing a lot of enthusiasm from our PALISADE sites about starting RAMSES, and many of them have waitlisted patients who are eager to participate in the trial.”
For more information about the RAMSES (ARC007) trial, please see:
https://clinicaltrials.gov/ct2/show/NCT03126227
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age and is currently being evaluated in Phase 3 clinical trials. For more information, please see www.aimmune.com.
References
1. Franxman TJ, Howe L, Teich E, Greenhawt MJ. Oral food challenge and food allergy quality of life in caregivers of children with food allergy. Journal of Allergy and Clinical Immunology: In Practice 2015; 3:50.
2. van der Velde, J.L., Flokstra-de Blok, B.M., de Groot, H., Oude-Elberink, J.N., Kerkhof, M., Duiverman, E.J. et al, Food allergy-related quality of life after double-blind, placebo-controlled food challenges in adults, adolescents, and children. Journal of Allergy and Clinical Immunology 2012; 130:1136–1143.e2.
SOURCE: Aimmune Therapeutics
Post Views: 28
“Real-World” Trial Will Augment Ongoing Phase 3 PALISADE Trial to Support Regulatory Filings and Market Understanding
BRISBANE, CA, USA I May 11, 2017 I Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the enrollment of its first patient in the Phase 3 RAMSES (ARC007) clinical trial of AR101 for treatment of peanut allergy. AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.
The Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Age 4-17 Years, or RAMSES (ARC007), trial is designed to gain experience with AR101 in a real-world setting, without the use of a double-blind, placebo-controlled food challenge (DBPCFC) to confirm peanut allergy. It will assess the safety and tolerability of AR101 versus placebo. The trial follows the same up-dosing and maintenance protocol as Aimmune’s ongoing Phase 3 PALISADE trial, taking place in the United States, Canada, and eight countries in Europe.
“The peanut-allergic patients in my practice have been highly motivated to participate in Aimmune’s clinical trials. They’re looking for access to a potential treatment, since peanut allergy patients are at risk for life-threatening anaphylaxis and have to take extra caution with eating. My patients have been happy to have the opportunity to participate in these clinical trials and help with the effort which may lead to an approved product to treat their problem,” said Stanley M. Fineman, M.D., Atlanta Asthma & Allergy. “Not requiring the diagnostic food challenge requirement is more consistent with the way we practice, where the diagnosis of peanut allergy is typically made based on a strong clinical history and corroborating positive skin prick tests and/or elevated blood levels of peanut antibodies.”
RAMSES (ARC007) is a randomized, double-blind, placebo-controlled trial enrolling approximately 440 peanut-allergic patients ages 4–17 at multiple sites in the United States and Canada. Patient selection is based on stringent entry criteria, including a well-documented medical history of IgE-mediated reactions to peanut (including anaphylaxis), skin reactivity, and analyses of peanut-specific allergic antibodies.
The trial will monitor treatment-emergent adverse events during a six-month up-dosing period, and then, after unblinding, follow patients for at least six months on the maintenance dose of 300 mg of AR101 per day. Aimmune anticipates that the absence of an entry food challenge may improve the tolerability profile of AR101 in early stages of dosing by removing exposure to high levels of peanut allergen that may otherwise prime the immune system prior to treatment.
“We’re conducting our RAMSES trial not only to support regulatory filings and real-world market understanding, but also to test whether removing the entry food challenge can lead to improved tolerability of AR101 during early up-dosing. Recent data from our collaborator Dr. Erik Wambre and his colleagues at the Benaroya Research Institute on PALISADE patient samples support the idea that the food challenge may activate the immune system and thus increase the risk of additional allergic reactions in the early up-dosing period that follows,” said Aimmune CMO, Daniel Adelman, M.D. “Also, while some studies1,2 have shown that food allergy patients and caregivers report improvements in quality of life following food challenges, regardless of outcome, the process can be emotionally tough. We’ve been hearing a lot of enthusiasm from our PALISADE sites about starting RAMSES, and many of them have waitlisted patients who are eager to participate in the trial.”
For more information about the RAMSES (ARC007) trial, please see:
https://clinicaltrials.gov/ct2/show/NCT03126227
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age and is currently being evaluated in Phase 3 clinical trials. For more information, please see www.aimmune.com.
References
1. Franxman TJ, Howe L, Teich E, Greenhawt MJ. Oral food challenge and food allergy quality of life in caregivers of children with food allergy. Journal of Allergy and Clinical Immunology: In Practice 2015; 3:50.
2. van der Velde, J.L., Flokstra-de Blok, B.M., de Groot, H., Oude-Elberink, J.N., Kerkhof, M., Duiverman, E.J. et al, Food allergy-related quality of life after double-blind, placebo-controlled food challenges in adults, adolescents, and children. Journal of Allergy and Clinical Immunology 2012; 130:1136–1143.e2.
SOURCE: Aimmune Therapeutics
Post Views: 28
