Kymera Announces Expansion of KT-474 (SAR444656) HS and AD Phase 2 Studies Following Interim Review of Safety and Efficacy
08 Julio 2024 - 3:05PM
Kymera 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 following a review of preliminary KT-474 safety and efficacy
data by an Independent Data Review Committee, Sanofi has informed
Kymera that it intends to expand the ongoing Hidradenitis
Suppurativa (HS) and Atopic Dermatitis (AD) Phase 2 trials to more
rapidly progress towards pivotal studies.
“We are pleased that Sanofi has taken steps to expand these
studies, as we are firm believers in the potential for KT-474 to
address significant unmet needs with large market potential,” said
Nello Mainolfi, PhD, Founder, President and CEO, Kymera
Therapeutics. “This expansion, supported by the results of the
interim analysis, is intended to accelerate overall timelines and
inform future registrational trials. We look forward to sharing
further information as it is available, including trial designs and
updated timing for the expanded Phase 2 data readouts.”
About KT-474 IRAK4 Degrader KT-474 (SAR444656)
is a first-in-class IRAK4 degrader in development for the treatment
of immune-inflammatory diseases with significant patient need, such
as hidradenitis suppurativa (HS), atopic dermatitis (AD), and
potentially others. IRAK4 is a key protein of the myddosome complex
that mediates signaling through IL-1 and toll-like receptors, which
play a crucial role in initiating the immune response against
invading pathogens. IRAK4 is a scaffolding kinase that acts at the
interface of the innate and adaptive immune responses with a
variety of functions depending on its kinase activity and
scaffolding function. Eliminating IRAK4 completely through
degradation impacts both the kinase and scaffolding functions,
therefore having the potential to achieve a broad, well-tolerated,
anti-inflammatory effect providing a novel therapeutic approach for
a variety of immune-inflammatory diseases. KT-474 was the first
heterobifunctional small molecule protein degrader to enter
clinical development for immunological diseases. Sanofi, which is
collaborating with Kymera on the development of KT-474 outside of
the oncology and immuno-oncology fields, is conducting randomized,
placebo-controlled Phase 2 clinical trials of KT-474 in both HS and
AD.
More information on the Phase 2 studies in HS (NCT06028230) and
AD (NCT06058156) can be found at www.clinicaltrials.gov.
About Kymera TherapeuticsKymera is a
clinical-stage biotechnology company pioneering the field of
targeted protein degradation (TPD) to develop medicines that
address critical health problems and have the potential to
dramatically improve patients’ lives. Kymera is deploying TPD to
address disease targets and pathways inaccessible with conventional
therapeutics. Having advanced the first degrader into the clinic
for immunological diseases, Kymera is focused on delivering oral
small molecule degraders to provide a new generation of convenient,
highly effective therapies for patients with these conditions.
Kymera is also progressing degrader oncology programs that target
undrugged or poorly drugged proteins to create new ways to fight
cancer. Founded in 2016, Kymera has been recognized as one of
Boston’s top workplaces for the past several years. For more
information about our science, pipeline and people, please visit
www.kymeratx.com or follow us on X (previously Twitter) or
LinkedIn.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, without limitation,
implied and express statements by Kymera Therapeutics regarding
its: strategy, business plans and objectives for its clinical
programs for KT-474; plans and timelines for the preclinical and
clinical development of its product candidates, including the
therapeutic potential, clinical benefits and safety thereof;
expectations regarding timing, success and data announcements of
current ongoing preclinical and clinical trials of KT-474; Sanofi’s
intent to expand the Phase2 clinical trials of KT-474; the ability
to initiate new clinical programs; and Kymera's financial condition
and expected cash runway into the first half of 2027. The words
"may," "might," "will," "could," "would," "should," "expect,"
"plan," "anticipate," "intend," "believe," "expect," "estimate,"
"seek," "predict," "future," "project," "potential," "continue,"
"target" and similar words or expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Any forward-looking
statements in this press release are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and important factors that may cause actual events or
results to differ materially from those expressed or implied by any
forward-looking statements contained in this press release,
including, without limitation, risks associated with: the timing
and anticipated results of our current and future preclinical
studies and clinical trials, supply chain, strategy and future
operations; the delay of any current and future preclinical studies
or clinical trials or the development of Kymera Therapeutics' drug
candidates; the risk that the results of current preclinical
studies and clinical trials may not be predictive of future results
in connection with current or future preclinical and clinical
trials, including for KT-474; Kymera Therapeutics' ability to
successfully demonstrate the safety and efficacy of its drug
candidates; the timing and outcome of the Kymera Therapeutics'
planned interactions with regulatory authorities; obtaining,
maintaining and protecting its intellectual property; the risks
associated with pandemics or epidemics; and Kymera Therapeutics'
relationships with its existing and future collaboration partners.
These and other risks and uncertainties are described in greater
detail in the section entitled "Risk Factors" in the Quarterly
Report on Form 10-Q for the period ended March 31, 2024, as well as
discussions of potential risks, uncertainties, and other important
factors in Kymera Therapeutics' subsequent filings with the
Securities and Exchange Commission. In addition, any
forward-looking statements represent Kymera Therapeutics' views
only as of today and should not be relied upon as representing its
views as of any subsequent date. Kymera Therapeutics explicitly
disclaims any obligation to update any forward-looking statements.
No representations or warranties (expressed or implied) are made
about the accuracy of any such forward-looking statements.
Investor and Media
Contact: Justine KoenigsbergVice President, Investor
Relationsinvestors@kymeratx.commedia@kymeratx.com 857-285-5300 |
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