CAMBRIDGE, Mass.--(BUSINESS WIRE)--Catabasis
Pharmaceuticals, Inc. (NASDAQ: CATB), a clinical-stage drug
development company built on a pathway pharmacology technology platform,
today announced that the first patient has been dosed in a Phase 2a
trial of CAT-2054 for the treatment of hypercholesterolemia. CAT-2054 is
an oral small molecule that modulates the SREBP pathway. SREBP is a
master regulator of lipid metabolism that impacts LDL, triglycerides and
glucose with the potential to impact liver fat and hepatocellular
carcinoma.
“Compared with currently approved cholesterol drugs, CAT-2054 represents
a novel pharmacologic approach to treating dyslipidemia”
The CAT-2054 Phase 2a trial is a 4-week randomized, double-blind,
placebo-controlled trial in patients with hypercholesterolemia.
Catabasis plans to enroll approximately 150 patients that will receive
one of four doses of CAT-2054 or placebo, both in addition to a stable
dose of a high intensity statin, atorvastatin 40 mg per day. The primary
efficacy endpoint for this trial will be percent reduction in LDL
cholesterol. Catabasis will also explore the activity of CAT-2054 on
other metabolic parameters such as triglycerides and glucose.
“Compared with currently approved cholesterol drugs, CAT-2054 represents
a novel pharmacologic approach to treating dyslipidemia,” said Harold
Bays, M.D., Medical Director / President of the Louisville Metabolic and
Atherosclerosis Research Center Inc. “Based on the encouraging Phase 1
study results, and the continued unmet need in treating patients with
abnormal lipid levels, we look forward to participating as a research
site in evaluating this agent.”
“CAT-2054, via its modulation of SREBP activity, has the potential to
impact LDL cholesterol, triglycerides and glucose metabolism,” said
Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Catabasis
Pharmaceuticals. “The initiation of the Phase 2a trial is an important
milestone in the development of CAT-2054 and signifies that we are one
step closer to potentially providing a novel oral treatment option to
patients with hypercholesterolemia.”
More information about the CAT-2054 Phase 2a trial can be found on ClinicalTrials.gov
under trial identifier NCT02608697.
About CAT-2054CAT-2054 is an investigational oral drug
initially being developed for the treatment of hypercholesterolemia in
patients for whom existing therapies are insufficient. By modulating the
SREBP pathway, CAT-2054 may inhibit production of important cholesterol
metabolism proteins such as PCSK9, HMG-CoA reductase, ATP citrate lyase
and NPC1L1. If approved, CAT-2054 may have the potential to be the first
therapy to simultaneously modulate cholesterol synthesis, clearance and
absorption. Catabasis is currently conducting a Phase 2a trial of
CAT-2054 in addition to high intensity statin therapy in patients with
hypercholesterolemia. Catabasis has previously reported positive
top-line Phase 1 data.
About CatabasisCatabasis Pharmaceuticals is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of novel therapeutics using its
proprietary Safely Metabolized And Rationally Targeted, or SMART, linker
technology platform. The Company's SMART linker technology platform is
based on the concept of treating diseases by simultaneously modulating
multiple targets in one or more related disease pathways. The Company
engineers bi-functional product candidates that are conjugates of two
molecules, or bioactives, each with known pharmacological activity,
joined by one of its proprietary SMART linkers. The SMART linker
conjugates are designed for enhanced efficacy and improved safety and
tolerability. The Company’s focus is on treatments for rare diseases.
The Company is also developing other product candidates for the
treatment of serious lipid disorders. For more information on the
Company's technology and pipeline of drug candidates, please visit .
Forward Looking StatementsAny statements in this press
release about future expectations, plans and prospects for the Company,
including statements about future clinical trial plans, the potential
therapeutic effectiveness of CAT-2054 and other statements containing
the words “believes,” “anticipates,” “plans,” “expects,” and similar
expressions, constitute forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
uncertainties inherent in the initiation and completion of preclinical
studies and clinical trials and clinical development of the Company’s
product candidates, including CAT-2054; availability and timing of
results from preclinical studies and clinical trials; whether interim
results from a clinical trial will be predictive of the final results of
the trial or the results of future trials; expectations for regulatory
approvals to conduct trials of or to market CAT-2054; availability of
funding sufficient for the Company’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements; other matters
that could affect the availability or commercial potential of CAT-2054;
and general economic and market conditions and other factors discussed
in the “Risk Factors” section of the Company’s Quarterly Report on Form
10-Q for the three months ended September 30, 2015, which is on file
with the Securities and Exchange Commission, and in other filings that
the Company may make with the Securities and Exchange Commission in the
future. In addition, the forward-looking statements included in this
press release represent the Company’s views as of the date of this press
release. The Company anticipates that subsequent events and developments
will cause the Company’s views to change. However, while the Company may
elect to update these forward-looking statements at some point in the
future, the Company specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the date
of this release.
Contacts
Catabasis Pharmaceuticals, Inc.Andrea Matthews, 617-349-1971amatthews@catabasis.com
