Kymera Therapeutics (KYMR) Reports First-in-Human Dose in Phase 1 Trial of KT-474
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Kymera Therapeutics, Inc. (NASDAQ: KYMR) today announced that the Company recently initiated dosing in the single ascending dose (SAD) portion of the Phase 1 clinical trial evaluating KT-474 in adult healthy volunteers and patients with atopic dermatitis or hidradenitis suppurativa. KT-474 is a potential first-in-class, highly active and selective, orally bioavailable IRAK4 degrader being developed for the treatment of toll-like receptor (TLR)/interleukin-1 receptor (IL-1R)-driven immune-inflammatory diseases, such as atopic dermatitis, hidradenitis suppurativa, rheumatoid arthritis and potentially other indications.
“We are excited to initiate dosing in the SAD portion of the Phase 1 trial of KT-474, marking the first time that a heterobifunctional small molecule degrader has ever been administered to healthy volunteers,” said Jared Gollob, MD, Chief Medical Officer of Kymera Therapeutics. “Atopic dermatitis, hidradenitis suppurativa and rheumatoid arthritis collectively impact millions of people in the U.S. alone, and we believe our novel approach of degrading IRAK4 with KT-474 offers the potential to improve outcomes over current treatment options. We look forward to our next milestone of establishing safety, on-target pharmacology, and mechanistic proof-of-concept with KT-474 in healthy volunteers later this year.”
The first-in-human Phase 1 trial is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered KT-474 in adult healthy volunteers and patients with atopic dermatitis or hidradenitis suppurativa. Additional information on this clinical trial can be found on www.clinicaltrials.gov.
“KT-474 is the first heterobifunctional protein degrader candidate to advance into the clinic for immune-inflammatory conditions, representing a significant achievement for Kymera and an important milestone for the whole field of targeted protein degradation,” said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics. “I am proud of the progress that our R&D organization has made to advance our first program into the clinic in only four years, and we are looking forward to the initiation of our IRAKIMiD and STAT3 Phase 1 oncology trials in 2021, setting up a transformational year for Kymera.”
About IRAK4 and KT-474
IRAK4 is a key protein involved in inflammation mediated by the activation of TLRs and IL-1Rs. Aberrant activation of these pathways is the underlying cause of multiple immune-inflammatory conditions. KT-474 is designed to block TLR/IL-1R-mediated inflammation more broadly compared to monoclonal antibodies targeting single cytokines and enable pathway inhibition that is superior to IRAK4 kinase inhibitors by abolishing both the kinase and scaffolding functions of IRAK4.
Kymera is collaborating with Sanofi on the development of degrader candidates targeting IRAK4, including KT-474 (SAR444656), outside of the oncology and immuno-oncology fields.
Pegasus™ is Kymera Therapeutics’ proprietary protein degradation platform, created by its team of experienced drug hunters to improve the effectiveness of targeted protein degradation and generate a pipeline of novel therapeutics for previously undruggable diseases. The platform consists of informatics-driven target identification, novel E3 ligases, proprietary ternary complex predictive modeling capabilities, and degradation tools.
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