Codexis Doses First Subjects in Phase 1a Trial of CDX-6114
July 09 2018 - 08:00AM
Codexis, Inc. (NASDAQ:CDXS), a leading protein engineering company,
announces that it has dosed the first subjects in a first-in-human
Phase 1a dose-escalation trial with CDX-6114, its orally
administered enzyme therapeutic being developed for the management
of phenylketonuria (PKU). The initiation of the trial
triggers a $4 million milestone payment to Codexis from Nestlé
Health Science under their strategic collaboration announced in
October 2017.
This randomized, double-blind, placebo-controlled Phase 1a trial
is intended to evaluate the safety and tolerability of CDX-6114 in
up to 32 healthy volunteers, with up to four cohorts receiving a
single dose of CDX-6114 at increasingly higher dose levels. Codexis
also expects to generate valuable pharmacology data from this
study, which will support the future development of the drug
candidate. The company expects to report topline results from the
Phase 1a trial in the fourth quarter of 2018.
“Initiation of this clinical trial is a major milestone in the
development of CDX-6114 for the management of the orphan metabolic
disorder PKU. CDX-6114 is the first biotherapeutic discovered using
our CodeEvolver® protein engineering platform to enter human
studies,” said Codexis President and CEO John Nicols.
“Commencement of this clinical trial further validates our
biotherapeutics strategy as PKU is the lead program in our
pipeline, which focuses generally on the discovery and development
of novel enzyme drug candidates for the treatment of rare
diseases.”
“PKU is caused by the deficiency or absence of the natural
enzyme for the metabolism of phenylalanine, and can lead to
intellectual disability, seizures and cognitive and behavioral
disabilities,” he added. “Physicians have been able to test
for PKU for more than 50 years, yet treatment options have been
limited primarily to dietary management. CDX-6114 is an
orally dosed, GI-stable therapeutic enzyme developed to compensate
for the missing natural enzyme.”
About Phenylketonuria (PKU) PKU is an inborn
metabolic disorder resulting from a mutation in the gene for the
enzyme that converts the essential amino acid phenylalanine,
present in almost all dietary protein, into tyrosine. As a result
of this deficiency, phenylalanine builds up to levels that are
toxic in the brain, causing serious neurological symptoms including
intellectual disability, seizures and cognitive and behavioral
disabilities. To avoid phenylalanine toxicity and the most severe
disease symptoms, individuals with PKU must follow a strict,
life-long diet that is low in phenylalanine and supplement their
diet with a synthetic phenylalanine-free formula to provide
sufficient nutrients. Maintaining a strict, life-long diet is a
challenge for individuals with PKU. There are an estimated 50,000
people with PKU in the developed world.
About Codexis, Inc. Codexis is a leading
protein engineering company that applies its proprietary
CodeEvolver® technology to develop proteins for a variety of
applications, including as biocatalysts for the commercial
manufacture of pharmaceuticals, fine chemicals and industrial
enzymes, and enzymes as biotherapeutics and for use in molecular
diagnostics. Codexis’ proven technology enables improvements in
protein performance, meeting customer needs for rapid,
cost-effective and sustainable manufacturing in multiple
commercial-scale implementations of biocatalytic processes. For
more information, see www.codexis.com.
Forward-Looking StatementsTo 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, including
Codexis’ expectation of receiving a $4 million milestone payment
from Nestlé Health Science as a result of commencing the Phase 1a
study, Codexis’ expectation of completing the Phase 1a trial and
reporting top line results in the fourth quarter of 2018, and
Codexis’ belief that the commencement of this clinical trial
further validates our biotherapeutics discovery and development
strategy. 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. Factors that could materially affect actual results
include, among others: Codexis’ dependence on its licensees and
collaborators; Codexis’ dependence on a limited number of products
and customers in its biocatalysis business; potential adverse
effects to Codexis’ business if its customers’ pharmaceutical or
food products are not received well in the markets; risks,
uncertainties and costs associated with the successful development
of biotherapeutic candidates, including obtaining development
partners for its biotherapeutic programs and progressing such
programs to clinical trials and regulatory approvals; Codexis’
ability to develop and commercialize new products for the
biocatalysis markets; Codexis’ dependence on a limited number of
contract manufacturers for large-scale production of its enzymes;
Codexis’ ability to deploy its technology platform in new market
spaces, including the fine chemicals, therapeutics and in vitro
molecular diagnostics markets; Codexis’ ability to comply with the
terms of its credit facility and its associated debt service
obligations; Codexis’ need for additional capital in the future in
order to expand its business or to adjust for market conditions or
strategic considerations, which may involve Codexis entering into
equity offerings, debt financings, credit facilities and/or
strategic collaborations; Codexis’ dependence on key personnel;
Codexis’ ability to establish and maintain adequate protection for
intellectual property, trade secrets and other proprietary rights
covering its technologies; and any claims by third parties that
Codexis is infringing their intellectual property rights or other
proprietary rights. 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 March 16, 2018 and Form 10-Q filed May 10,
2018, including under the caption “Risk Factors” and in Codexis’
other current and periodic reports filed with the SEC. Codexis
expressly disclaims any intent or obligation to update these
forward-looking statements, except as required by law.
Codexis Contacts:
InvestorsLHA Investor RelationsJody Cain, (310)
691-7100jcain@lhai.com
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