CK-0045 induced exposure-dependent reductions
in body weight and improvement of key metabolic parameters in
participants with obesity
Data support advancement of CK-0045 into Phase
2 proof-of-concept studies in individuals with type 2 diabetes
and/or obesity
COPENHAGEN, Denmark, July 23,
2024 /PRNewswire/ -- Cytoki Pharma,
ApS (Cytoki), a clinical-stage biotechnology company
pioneering a new class of medicines that harness IL-22 biology to
drive improved outcomes for metabolic disease, today announced
positive data from a Phase 1 study evaluating the safety,
tolerability, and pharmacokinetics of CK-0045, its lead lipidated
IL-22 candidate, in healthy participants and otherwise healthy
participants with obesity. The data signal the effect of CK-0045
across several key metabolic parameters including body weight,
cholesterol, blood glucose levels, and insulin sensitivity.
"As the obesity treatment landscape continues to evolve, there
remains a need for approaches that drive lasting disease
modification through healthy weight loss and broader, deeper weight
loss-independent metabolic effects," said Rasmus Jorgensen,
Ph.D., Founder and CEO of Cytoki Pharma. "We believe CK-0045 offers
a differentiated opportunity to address obesity and type 2
diabetes, either as monotherapy or in combination with other
clinical approaches and are encouraged by these first data
supporting CK-0045's unique mechanism of action."
IL-22 is a non-immunomodulatory cytokine that selectively
targets epithelial tissues such as the gut and liver. Previously
reported preclinical data demonstrate the potential of lipidated
IL-22 to reduce body weight and improve glucose homeostasis in mice
through a novel mode-of-action.
Results from the Phase 1 study signal successful translation of
the preclinical findings to humans, with confirmed target
engagement based on liver and gut-derived biomarkers.
Pharmacokinetic data confirm feasibility of once weekly
subcutaneous dosing. CK-0045 induced exposure-dependent reductions
in body mass that were complemented by beneficial reductions in
low-density lipoprotein cholesterol, blood insulin concentration,
and insulin resistance—particularly in participants with reduced
insulin sensitivity.
CK-0045 was safe and tolerated across the multiple ascending
dose portion of the study, with all but one participant having
completed dosing. The most commonly occurring side effects were
mild skin reactions and a notable absence of substantial
gastrointestinal effects was observed.
The available clinical data support advancement of CK-0045 into
Phase 2 proof-of-concept studies in individuals with obesity and
type 2 diabetes to further assess the clinical relevance of
observed effects. Initiation of the Phase 2 is anticipated in the
second half of 2024.
About CK-0045
CK-0045 is a long-acting analogue of
interleukin-22 (IL-22), an atypical, non-immunomodulatory cytokine
that selectively targets epithelial cells. In-licensed from Novo
Nordisk A/S, CK-0045 incorporates validated technology to optimize
the pharmacologic properties of the endogenous IL-22 protein to
create a differentiated, first-in-class therapy with potential to
address a broad range of metabolic diseases, including obesity and
type 2 diabetes, and conditions characterized by epithelial injury,
such as inflammatory bowel disease. CK-0045 has been evaluated in a
randomized, double-blind, placebo-controlled Phase 1 study designed
to investigate its safety, tolerability, and pharmacokinetics in
healthy individuals with and without obesity (NCT05712876). CK-0045
is expected to enter Phase 2 studies in the second half of
2024.
About Cytoki Pharma
Cytoki Pharma is a clinical-stage
biotechnology company pioneering a new class of medicines that
harness IL-22 biology to drive improved outcomes for
cardiometabolic disease. Cytoki's lead program, CK-0045, is a
lipidated IL-22 analogue that has been evaluated in a Phase 1
clinical study and is expected to enter Phase 2 clinical studies in
the second half of 2024. The lead compound is selected from a full
program of therapeutic IL-22 variants based on an exclusive license
from Novo Nordisk A/S. The company is also advancing a broader
portfolio of preclinical IL-22-based assets for the treatment of
metabolic disease and inflammatory bowel disease. Cytoki was
founded in 2019 and is led by a team of pharma industry veterans
with deep expertise in the discovery and clinical development of
novel drugs. Please visit www.cytokipharma.com or follow us on
LinkedIn for additional details.
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SOURCE Cytoki Pharma