Cumberland
initiating Phase II FIGHTING FIBROSIS™ clinical
trial,
Newest program in Cumberland's ifetroban pipeline
NASHVILLE, Tenn., May 23, 2023
/PRNewswire/ -- Cumberland Pharmaceuticals Inc.
(Nasdaq:CPIX) today announced that the U.S. Food and Drug
Administration (FDA) has cleared the Investigational New Drug
Application (IND) for a Phase II study in patients with Idiopathic
Pulmonary Fibrosis, the most common form of progressive fibrosing
interstitial lung disease. As a result, Cumberland will launch its FIGHTING FIBROSIS
trial designed to enroll 128 patients in over 20 medical centers of
excellence across the U.S.
Idiopathic Pulmonary Fibrosis (IPF) is the newest
clinical program in the pipeline for Cumberland's first new chemical entity:
ifetroban – a potent and selective thromboxane receptor antagonist.
The Company has designed a Phase II clinical trial to study the
safety, tolerability, and efficacy of oral ifetroban in patients
with IPF. Recent studies have shown ifetroban can both prevent and
enhance resolution of lung fibrosis in multiple preclinical
models.
Cumberland previously received
IND clearance from the FDA for several indications including
Systemic Sclerosis and Duchenne Muscular Dystrophy. Phase II
clinical studies in patients with those conditions are well
underway.
"We are pleased that the FDA has cleared this new clinical
program as we work to develop new medicines for the future –
especially those that address unmet medical needs," said A.J.
Kazimi, Cumberland Pharmaceuticals Chief Executive Officer. "Given
the exciting preclinical data demonstrating ifetroban can prevent
lung fibrosis, we are very excited to advance directly to a Phase
II study for IPF patients."
About the new Phase II Clinical Trial
The FIGHTING FIBROSIS™ clinical trial is a
multicenter, double-blind, placebo-controlled Phase II study in
patients with IPF. The study will investigate the safety and
efficacy of once daily oral ifetroban for 52 weeks. Subjects
will be block randomized by background therapy (pirfenidone or
nintedanib) and assigned to one of two treatment groups, ifetroban
or placebo, at a dose of 250 mg daily. Approximately 128 subjects
with IPF will be enrolled in the U.S. The primary objective is to
improve lung function, as measured by the FVC in IPF patients on
ifetroban compared to placebo over 52 weeks.
About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a progressive
interstitial lung disease marked by inflammation and fibrosis of
the lungs, resulting in rapidly declining lung function and reduced
survival within 5 years of diagnosis. IPF is the most common form
of interstitial lung disease and is estimated to affect up to 2
million individuals globally.
While FDA-approved antifibrotic therapies have shown efficacy to
slow progression of the disease, there is no approved treatment
which effectively halts disease progression and improves patients'
symptoms. Therefore, an unmet need exists to identify additional
treatments which add benefit and provide alternatives to existing
therapies.
About Ifetroban
Ifetroban is a potent and selective thromboxane-prostanoid
receptor (TPr) antagonist. Ifetroban exhibits high affinity for TPr
on many cell types including platelets, vascular and airway smooth
muscle, and fibroblasts, and lacks agonistic activity. Ifetroban
also displays anti-platelet, antivasospastic, antifibrotic, and
antibronchospastic activities and is effective in certain
preclinical models of vasospasm, thrombosis, reperfusion injury,
cardiac fibrosis, lung fibrosis and endothelial dysfunction,
including models that are insensitive to aspirin.
Cumberland previously announced
the acquisition of the ifetroban program in collaboration with
Vanderbilt University and Cumberland
Emerging Technologies (CET).
Cumberland is also sponsoring
the FIGHT DMD™ trial, a multicenter, randomized, placebo-controlled
Phase II study evaluating two doses of oral ifetroban for the
treatment of the cardiomyopathy associated with Duchenne muscular
dystrophy, a rare and fatal genetic disorder. The FDA awarded
Cumberland $1 million in funding under its orphan products
grants program to support this trial. This was the first DMD trial
awarded such funding.
Cumberland recently completed a
Phase II study investigating ifetroban in patients with
aspirin-exacerbated respiratory disease (AERD), a rare and severe
form of asthma. While the Phase II AERD study showed ifetroban
improved patient symptoms, and significantly in some cases, there
was not a statistically significant difference with the comparator
arm of the study.
The Company plans to complete each of these sponsored studies,
analyze data, announce top-line results, and then decide on the
best development path for the registration of ifetroban, which has
the potential to benefit many patients with orphan diseases that
represent unmet medical needs.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical
company focused on the delivery of high-quality prescription brands
to improve patient care. The Company develops, acquires, and
commercializes brands for the hospital acute care, gastroenterology
and rheumatology market segments. The Company's portfolio of
FDA-approved brands includes:
- Acetadote® (acetylcysteine) Injection,
for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) Injection, for
the treatment of pain and fever;
- Vaprisol® (conivaptan) Injection, to
raise serum sodium levels in hospitalized patients with euvolemic
and hypervolemic hyponatremia;
- Vibativ® (telavancin) Injection, for
the treatment of certain serious bacterial infections including
hospital-acquired and ventilator-associated bacterial pneumonia, as
well as complicated skin and skin structure infections;
- Kristalose® (lactulose) for Oral
Solution, a prescription laxative, for the treatment of chronic and
acute constipation;
- Omeclamox®-Pak, (omeprazole,
clarithromycin, amoxicillin) for the treatment of Helicobacter
pylori (H. pylori) infection and related duodenal ulcer
disease; and
- Sancuso® (granisetron)
transdermal, for the prevention of nausea and vomiting in patients
receiving certain types of chemotherapy treatment.
For more information on Cumberland's approved products, including full
prescribing information, please visit the individual product
websites, links to which can be found on the Company's website
www.cumberlandpharma.com.
About Cumberland Emerging Technologies
Cumberland Emerging Technologies, Inc. is a joint initiative
between Cumberland Pharmaceuticals Inc., Vanderbilt University, Launch Tennessee and
WinHealth Pharma. The mission of CET is to bring biomedical
technologies and products conceived at Vanderbilt and other regional research centers to
the marketplace. CET helps manage the development and
commercialization process for select projects and provides
expertise on intellectual property, regulatory, manufacturing and
marketing issues that are critical to successful new biomedical
products. CET's Life Sciences Center, located in Nashville, Tennessee, provides laboratory
space, equipment and infrastructure to early-stage life sciences
companies.
Forward-Looking Statements
This press release contains forward-looking statements, which
are subject to certain risks and reflect Cumberland's current views on future events
based on what it believes are reasonable assumptions. No assurance
can be given that these events will occur. As with any business,
all phases of Cumberland's
operations are subject to factors outside of its control, and any
one or combination of these factors could materially affect
Cumberland's results of
operations. These factors include market conditions, competition,
an inability of manufacturers to produce Cumberland's products on a timely basis or
failure of manufacturers to comply with regulations applicable to
pharmaceutical manufacturers, maintaining an effective sales and
marketing infrastructure, natural disasters, public health
epidemics, and other events beyond our control, as more fully
discussed in the Company's most recent Form 10-K and subsequent
10-Qs as filed with the SEC. There can be no assurance that results
anticipated by the Company will be realized or that they will have
the expected effects. Readers are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the
date hereof. The Company does not undertake any obligation to
publicly revise these statements to reflect events after the date
hereof.
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SOURCE Cumberland Pharmaceuticals Inc.