Codexis and Nestlé Health Science Announce Interim Results from Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency
February 23 2023 - 4:05PM
Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company,
and Nestlé Health Science, a leader in the science of nutrition,
today announced interim results from a Phase 1 study to investigate
the safety, tolerability, pharmacokinetics (PK), and
pharmacodynamics of CDX-7108.
CDX-7108 is a lipase variant specifically engineered to overcome
the limitations of existing pancreatic enzyme replacement therapy
(PERT). PERT is the main treatment for exocrine pancreatic
insufficiency (EPI), a debilitating condition of the GI tract that
is caused by conditions that impair pancreatic function such as
pancreatitis, pancreatic cancer, Crohn’s disease, celiac disease,
and cystic fibrosis. CDX-7108 was engineered to be highly stable to
the acidic conditions in the stomach and resistant to proteases in
the upper intestines.
“We are excited by the early clinical data for CDX-7108, the
most advanced candidate from our partnership with Nestlé Health
Science,” said Stephen Dilly, MBBS, PhD, President and Chief
Executive Officer of Codexis. “Preliminary data from an interim
analysis of our Phase 1 study proof-of-concept arm has shown
indication of improved lipid absorption when patients were
administered CDX-7108 versus placebo. Importantly, no safety issues
were noted in the 48 subjects who participated in the single
ascending dose and multiple ascending dose portion of the study.
These encouraging data support a path forward further developing
CDX-7108 with Nestlé Health Science. We aim for the potential
initiation of a Phase 2 study in early 2024.”
“Patients who suffer from exocrine pancreatic insufficiency are
in need of new treatment options,” said Dr. Hans-Juergen Woerle,
Chief Scientific and Medical Officer of Nestlé Health Science.
“This interim Phase 1 data suggests that CDX-7108 could be that
potential new option and we are excited to move forward to a Phase
2 clinical trial. We are pleased with this positive update and are
proud to be driving the development of a novel approach for this
condition as part of our strategic collaboration with Codexis.”
Results of Interim Analysis
The CDX-7108 Phase 1 clinical trial is a study evaluating the
safety, tolerability, and pharmacokinetics (PK) of escalating oral
doses of CDX-7108 in 48 healthy adult subjects and to assess the
pharmacodynamics of oral doses of CDX-7108 as part of a
proof-of-concept study in 10 subjects with EPI. The interim
analysis included 5 subjects and examined lipid absorption as
measured by 13CO2 excretion. No safety issues were noted with no
Serious Adverse Events (SAE) observed and no treatment
discontinuations in the Single Ascending Dose (SAD) and Multiple
Ascending Dose (MAD) healthy subject groups. Every participant with
EPI in the proof-of-concept portion of the study showed improved
lipid absorption when administered CDX-7108 versus placebo.
Combining the data from each participant, a significant increase in
the cumulative excretion rate of 13CO2 was observed for CDX-7108
versus placebo.
Codexis and Nestlé Health Science expect to file an
Investigational New Drug (IND) application for the Phase 2 study by
the end of 2023. The Phase 2 study is expected to be conducted over
approximately 12 months, with topline data expected in 2025.
About Nestlé Health Science (NHSc)
Nestlé Health Science, a leader in the science of nutrition, is
a globally managed business unit of Nestlé. We are committed to
redefining the management of health, offering an extensive
portfolio of science-based consumer health, medical nutrition,
pharmaceutical therapies, and vitamin and supplement brands. Our
extensive research network provides the foundation for products
that empower healthier lives through nutrition. Headquartered in
Switzerland, we have more than 12,000 employees around the world,
with products available in more than 140
countries. www.nestlehealthscience.com.
About Codexis
Codexis is a leading enzyme engineering company leveraging its
proprietary CodeEvolver® platform to discover and develop
novel, high performance enzymes and biotherapeutics. Codexis
enzymes have applications in the sustainable manufacturing of small
molecule pharmaceuticals, in RNA and DNA synthesis and the creation
of next generation life science tools, and as gene therapies and
oral enzyme therapies. Codexis’ unique enzymes can drive
improvements such as higher yields, reduced energy usage and waste
generation, improved return on capital in manufacturing, improved
sensitivity in genomic and diagnostic applications, and more
efficacious therapeutics. For more information,
visit www.codexis.com.
Forward-Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Codexis, they
are forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
statements regarding the Company’s programs having the potential to
create significant value over the next few years and the Company’s
enzymes being able to drive improvements. You should not place
undue reliance on these forward-looking statements because they
involve known and unknown risks, uncertainties and other factors
that are, in some cases, beyond Codexis’ control and that could
materially affect actual results. Additional information about
factors that could materially affect actual results can be found in
Codexis’ Annual Report on Form 10-K filed with the Securities and
Exchange Commission (“SEC”) on February 28, 2022 and in Codexis’
Quarterly Report on Form 10-Q filed with the SEC on November 4,
2022, including under the caption “Risk Factors,” and in Codexis’
other periodic reports filed with the SEC. Codexis expressly
disclaims any intent or obligation to update these forward-looking
statements, except as required by law.
Investor Relations Contact:
Argot PartnersBrendan Strong/Carrie McKim(212)
600-1902Codexis@argotpartners.com
Media Relations Contact:
Lauren Musto(781) 572-1147lauren.musto@codexis.com
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