- BREAKOUT Study is Palatin's third
clinical program for the potential treatment of inflammatory
diseases with melanocortin agonists
- Primary endpoint of the BREAKOUT Study
is a 50% reduction in urine protein/creatinine (UP/Cr) ratio after
six months of combined therapy (RAAS inhibition therapy plus
bremelanotide)
CRANBURY, N.J., Jan. 19,
2023 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE
American: PTN), a biopharmaceutical company
developing first-in-class medicines based on molecules
that modulate the activity of the melanocortin receptor system,
today announced the initiation of a Phase 2b clinical trial with the melanocortin agonist,
bremelanotide. The BREAKOUT Study, entitled "A Phase
2b, Multicenter, Open-Label,
Prospective Study of BREmelanotide in DiAbetic
Kidney Disease to Assess the Efficacy in Reducing Urinary
PrOtein and Maintaining Podocyte Density and
FUncTion" initiated patient screening/enrollment
in December 2022, and currently
expects to initiate patient dosing in January 2023.
The BREAKOUT Study (BMT-701) is designed to enroll up to 45
subjects, with biopsy-proven type II diabetic kidney disease and
>1000 mg/gm UP/Cr ratio. Patients will administer bremelanotide
therapy twice a day (BID), in addition to their maximum tolerated
RAAS inhibition therapy, for six months, followed by a 12-month
follow-up period. The primary endpoint of the study is a 50%
reduction in their urine protein/creatinine (UP/Cr) ratio after six
months of combined therapy (RAAS inhibition therapy plus
bremelanotide). Secondary endpoints include analyses of partial
remission, clinical remission and change in eGFR.
"We are pleased to initiate the Phase 2 BREAKOUT study which
utilizes our robust melanocortin anti-inflammation/pro-resolution
platform," said Carl Spana, Ph.D.,
President and CEO of Palatin. "We continue to execute on our
strategy that the melanocortin system is an important mechanism for
the resolution of inflammation and promotion of tissue repair. With
the BREAKOUT Study, we now have three active melanocortin-based
clinical programs: our MELODY-1 Phase 3 dry eye disease trial, a
Phase 2 ulcerative colitis trial and a Phase 2 diabetic kidney
disease trial, all with data readouts throughout calendar year
2023."
The open label BREAKOUT Study will enroll patients at up to
seven U.S. sites. Completed patient data will be reviewed and
assessed throughout the Study. Based on current enrollment
estimates, the BREAKOUT Study is expected to complete enrollment in
the third quarter of calendar year 2023, with final topline data by
end of the first quarter of calendar year 2024.
"Diabetic nephropathy is one of the leading causes of end-stage
renal disease across the world. It is characterized by progressive
loss of kidney function over a 10-to-15-year period," said
James A. Tumlin MD, CEO and Founder
of NephroNet Clinical Trials Consortium. "This exciting new
development of using bremelanotide as a first in class activator
for a new treatment pathway in diabetic kidney disease, could
potentially offer kidney doctors new and powerful tools to treat
this very common disease."
About Diabetic (Nephropathy) Kidney Disease
Diabetic nephropathy is the most common cause of end-stage renal
disease in the United States and
other developed countries. Approximately 30 million U.S. patients
have chronic kidney disease secondary to the combination of
hypertension and Type II diabetes mellitus. Despite this remarkable
prevalence, clinicians have little consensus on what comprises
optimal therapy. While the widespread use of RAAS blockade
utilizing angiotensin-converting enzyme inhibitors and angiotensin
II receptor blockers and other maneuvers have slowed disease
progression, approximately one-third of patients with Type II
diabetic nephropathy will progress to end-stage renal disease. As a
result, much effort has been devoted to understanding the
mechanisms by which the diabetic condition leads to the typical
histopathologic changes, including mesangial expansion, thickened
basement membranes, and loss of podocyte density and
functionality.
There is evidence that injury to the glomerular podocyte is
central to the pathogenesis of diabetic nephropathy and that
clinical treatments should be directed toward maintaining podocyte
viability. Podocytes are highly differentiated neuron-like cells
with limited cell division and replacement capacity. They are
central to the support and maintenance of glomerular capillary
networks and function as the final barrier in glomerular
filtration. Evidence from pre-clinical animal model studies
suggests that podocyte losses precede and contributes to
progressive diabetic glomerulopathy. Hyperglycemia leading to
increased intracellular calcium and oxidant load contributes to
accelerated podocyte apoptosis, autophagy, and cellular
detachment.
About Melanocortins and Kidney Disease
Melanocortin receptors ("MCr") comprise a complex system of five
different receptors with broad and varying physiologic functions.
One of these receptors, MC1r, signals through a G-protein coupled
pathway that leads to activation of adenylate cyclase and
ultimately, stimulation of the serine-threonine kinase activity of
protein kinase A. A growing body of work in cell signaling and
function of the glomerular podocyte suggests that protein kinase A
regulates the formation of footplate processes, cell attachment,
and apoptosis. MC1r activation may stabilize podocyte function and
survival in diabetes and other conditions of glomerular
diseases.
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor system has effects on
inflammation, immune system responses, metabolism, food intake, and
sexual function. Modulation of the five melanocortin receptors,
MC1r through MC5r, using receptor-specific agonists, which activate
receptor function, or receptor-specific antagonists, which block
receptor function, can have medically significant pharmacological
effects. Many tissues and immune cells located throughout the body,
including the gut, kidney and eye, express melanocortin receptors,
empowering our opportunity to directly activate natural pathways to
resolve disease inflammation.
About Palatin
Palatin is a biopharmaceutical company developing first-in-class
medicines based on molecules that modulate the activity of the
melanocortin receptor systems, with targeted, receptor-specific
product candidates for the treatment of diseases with significant
unmet medical need and
commercial potential. Palatin's strategy
is to develop products and then form
marketing collaborations with industry leaders to maximize their
commercial potential. For additional information regarding Palatin,
please visit Palatin's website at www.Palatin.com and follow
Palatin on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin, such as
statements about clinical trials and results, are "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and as
that term is defined
in the Private Securities Litigation Reform Act of 1995. Palatin
intends that such forward-looking statements be subject to the
safe harbors created thereby. Such forward-looking statements
involve known and unknown risks, uncertainties and other
factors that could cause Palatin's actual results to be materially different from its historical
results or from any results expressed or implied by such
forward-looking statements. Palatin's actual results may differ
materially from those discussed in the forward-looking statements
for reasons including, but not limited to, results of clinical
trials, regulatory actions by the FDA and other regulatory and the
need for regulatory approvals, Palatin's ability to fund
development of its technology and establish and successfully
complete clinical trials, the length of time and cost required to
complete clinical trials and submit applications for regulatory
approvals, products developed by competing pharmaceutical,
biopharmaceutical and biotechnology companies, commercial
acceptance of Palatin's products, and other factors discussed in
Palatin's periodic filings with the Securities and Exchange
Commission. Palatin is not responsible for updating for events that
occur after the date of this press release.
Palatin Technologies® is a registered trademark of Palatin
Technologies, Inc.
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SOURCE Palatin Technologies, Inc.