The dosing of the first patient in the Phase 2 Atopic Dermatitis (AD) clinical trial is expected later this quarter
WATERTOWN, MA, USA I October 27, 2023 IKymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that the first patient has been dosed in the randomized Phase 2 clinical trial in hidradenitis suppurativa (HS) evaluating KT-474 (SAR444656), a first-in-class, investigational IRAK4 degrader. The Phase 2 study will evaluate the efficacy, safety, pharmacokinetics, and biological effects of KT-474 compared with placebo in adult patients with moderate to severe HS. Kymera’s partner Sanofi is conducting the Phase 2 study in HS, and has initiated a second randomized Phase 2 trial in AD. Under the terms of the collaboration, dosing of the first patient in the HS trial generated a milestone payment of $40 million. Dosing of the first patient in the AD trial will also generate a milestone payment to Kymera.
“The initiation of dosing in the first Phase 2 trial of KT-474 in HS is an important step in the development of this molecule and a significant achievement for Kymera in demonstrating the potential of protein degradation to transform the treatment of complex, inflammatory diseases with small molecules,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “Based on the encouraging KT-474 Phase 1 results, we believe that this molecule has the potential to offer HS patients a well-tolerated and effective oral drug. We look forward to sharing additional updates as our partner Sanofi advances this program, including dosing the first patient in the second Phase 2 trial in AD later this quarter.”
“At Sanofi, we’ve very excited about the potential of protein degraders to deliver new treatments for immunological and inflammatory diseases by selectively targeting specific proteins and critical pathways, like IRAK4,” said Naimish Patel, MD, Head of Global Development, Immunology and Inflammation, Sanofi. “HS is a chronic, debilitating skin disease whereby there remains a tremendous need for new treatment options. We look forward to progressing the Phase 2 program in HS and AD.”
About KT-474
KT-474 is an oral IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven complex inflammatory diseases where there is an opportunity to significantly advance the standard of care, including HS and AD. In the Phase 1 trial, KT-474 showed evidence of robust IRAK4 degradation in the blood and active skin lesions of HS and AD patients and was generally well tolerated. Treatment with KT-474 was associated with a systemic anti-inflammatory response and improvement in skin lesions and symptoms in both HS and AD patients, with internal consistency between the effect on inflammatory biomarkers and impact on clinical endpoints. KT-474 was generally safe and well-tolerated, with no serious adverse events, no drug-related infections, and no dose interruptions or discontinuations due to adverse events.
The safety and efficacy of KT-474 (SAR444656) is currently being evaluated in double blind, placebo-controlled, randomized Phase 2 clinical trials in adult patients with moderate to severe HS and AD. Sanofi, which is collaborating with Kymera on the development of KT-474 outside of the oncology and immune-oncology fields, is conducting the Phase 2 studies.
More information on the Phase 2 studies in HS (NCT06028230) and AD (NTC06058156) can be found at www.clinicaltrials.gov.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that causes painful lumps deep in the skin. It results in painful nodules and abscesses that can persist and worsen over time. It can affect daily life and emotional well-being, especially as the disease progresses. HS tends to start after puberty, usually before age 40. There are no FDA approved oral treatments for HS.
About Kymera Therapeutics
Kymera is a biopharmaceutical company pioneering the field of targeted protein degradation, a transformative approach to address disease targets and pathways inaccessible with conventional therapeutics. Kymera’s Pegasus platform is a powerful drug discovery engine, advancing novel small molecule programs designed to harness the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. With a focus on undrugged nodes in validated pathways, Kymera is advancing a pipeline of novel therapeutic candidates designed to address the most promising targets and provide patients with more effective treatments. Kymera’s initial programs target IRAK4, IRAKIMiD, and STAT3 within the IL-1R/TLR or JAK/STAT pathways, and the MDM2 oncoprotein, providing the opportunity to treat patients with a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors.
Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a “Fierce 15” company by Fierce Biotech and has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston’s top workplaces. For more information about our people, science and pipeline, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
SOURCE: Kymera Therapeutics
Post Views: 122
The dosing of the first patient in the Phase 2 Atopic Dermatitis (AD) clinical trial is expected later this quarter
WATERTOWN, MA, USA I October 27, 2023 IKymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that the first patient has been dosed in the randomized Phase 2 clinical trial in hidradenitis suppurativa (HS) evaluating KT-474 (SAR444656), a first-in-class, investigational IRAK4 degrader. The Phase 2 study will evaluate the efficacy, safety, pharmacokinetics, and biological effects of KT-474 compared with placebo in adult patients with moderate to severe HS. Kymera’s partner Sanofi is conducting the Phase 2 study in HS, and has initiated a second randomized Phase 2 trial in AD. Under the terms of the collaboration, dosing of the first patient in the HS trial generated a milestone payment of $40 million. Dosing of the first patient in the AD trial will also generate a milestone payment to Kymera.
“The initiation of dosing in the first Phase 2 trial of KT-474 in HS is an important step in the development of this molecule and a significant achievement for Kymera in demonstrating the potential of protein degradation to transform the treatment of complex, inflammatory diseases with small molecules,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “Based on the encouraging KT-474 Phase 1 results, we believe that this molecule has the potential to offer HS patients a well-tolerated and effective oral drug. We look forward to sharing additional updates as our partner Sanofi advances this program, including dosing the first patient in the second Phase 2 trial in AD later this quarter.”
“At Sanofi, we’ve very excited about the potential of protein degraders to deliver new treatments for immunological and inflammatory diseases by selectively targeting specific proteins and critical pathways, like IRAK4,” said Naimish Patel, MD, Head of Global Development, Immunology and Inflammation, Sanofi. “HS is a chronic, debilitating skin disease whereby there remains a tremendous need for new treatment options. We look forward to progressing the Phase 2 program in HS and AD.”
About KT-474
KT-474 is an oral IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven complex inflammatory diseases where there is an opportunity to significantly advance the standard of care, including HS and AD. In the Phase 1 trial, KT-474 showed evidence of robust IRAK4 degradation in the blood and active skin lesions of HS and AD patients and was generally well tolerated. Treatment with KT-474 was associated with a systemic anti-inflammatory response and improvement in skin lesions and symptoms in both HS and AD patients, with internal consistency between the effect on inflammatory biomarkers and impact on clinical endpoints. KT-474 was generally safe and well-tolerated, with no serious adverse events, no drug-related infections, and no dose interruptions or discontinuations due to adverse events.
The safety and efficacy of KT-474 (SAR444656) is currently being evaluated in double blind, placebo-controlled, randomized Phase 2 clinical trials in adult patients with moderate to severe HS and AD. Sanofi, which is collaborating with Kymera on the development of KT-474 outside of the oncology and immune-oncology fields, is conducting the Phase 2 studies.
More information on the Phase 2 studies in HS (NCT06028230) and AD (NTC06058156) can be found at www.clinicaltrials.gov.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that causes painful lumps deep in the skin. It results in painful nodules and abscesses that can persist and worsen over time. It can affect daily life and emotional well-being, especially as the disease progresses. HS tends to start after puberty, usually before age 40. There are no FDA approved oral treatments for HS.
About Kymera Therapeutics
Kymera is a biopharmaceutical company pioneering the field of targeted protein degradation, a transformative approach to address disease targets and pathways inaccessible with conventional therapeutics. Kymera’s Pegasus platform is a powerful drug discovery engine, advancing novel small molecule programs designed to harness the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. With a focus on undrugged nodes in validated pathways, Kymera is advancing a pipeline of novel therapeutic candidates designed to address the most promising targets and provide patients with more effective treatments. Kymera’s initial programs target IRAK4, IRAKIMiD, and STAT3 within the IL-1R/TLR or JAK/STAT pathways, and the MDM2 oncoprotein, providing the opportunity to treat patients with a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors.
Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a “Fierce 15” company by Fierce Biotech and has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston’s top workplaces. For more information about our people, science and pipeline, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
SOURCE: Kymera Therapeutics
Post Views: 122
