Osprey Pharmaceuticals U.S.A., Inc. Initiates Phase Ib Clinical Trial in IgA Nephropathy

Osprey Pharmaceuticals U.S.A., Inc. Initiates Phase Ib Clinical Trial in IgA
Nephropathy

Trial to Evaluate Safety of CCL2-LPM for Inflammatory Kidney Disease

SAN FRANCISCO, April 14 /PRNewswire/ -- Osprey Pharmaceuticals U.S.A., Inc.
announced today that patient dosing has commenced in a Phase Ib clinical trial
of the company's lead compound, CCL2-LPM, for the treatment of IgA
nephropathy, an inflammatory kidney disease. Osprey Pharmaceuticals U.S.A. is
developing novel chemokine-enzyme fusion protein therapeutics, known as
Leukocyte Population Modulators (LPMs), for the treatment of inflammatory and
autoimmune diseases. CCL2-LPM selectively targets activated leukocytes
expressing the chemokine receptor CCR2 that are responsible for initiating and
maintaining a variety of inflammatory conditions.

The Phase Ib open-label, dose-escalating study will enroll up to 30 patients
diagnosed with IgA nephropathy at clinical sites in Canada. The trial design
utilizes a continuous reassessment method to evaluate safety of CCL2-LPM and
to establish a maximum-tolerated dose. Secondary endpoints for the Phase Ib
clinical trial include an assessment of pharmacokinetics and biomarkers of
disease associated with the mechanism of action of CCL2-LPM.

"We are pleased to advance the first of our LPM compounds designed to target
and neutralize chemokine-mediated inflammation into clinical trials. CCL2-LPM
has shown a favorable pharmaceutical profile, demonstrating efficacy at low
doses in models of glomerulonephritis, as well as tolerability at relatively
high doses in preclinical toxicology testing," said Barbara Finck, M.D, Senior
Vice President of Research and Development and Chief Medical Officer for
Osprey Pharmaceuticals U.S.A., Inc. "We are hopeful that the Phase Ib clinical
trial of CCL2-LPM will provide us with indications of the compound's biologic
activity in addition to establishing safety. Initial results from the Phase Ib
study are expected later this year."

CCL2-LPM is the most advanced of Osprey Pharmaceutical U.S.A.'s drug
candidates based on the company's proprietary platform of therapeutic
Leukocyte Population Modulators (LPMs). LPMs specifically target
chemokine-activated leukocytes that drive and/or maintain a variety of
inflammatory and autoimmune disorders. The CCL2-CCR2 chemokine ligand-receptor
axis plays a significant role in inflammatory kidney diseases such as IgA
nephropathy and diabetic nephropathy, as well as a variety of other autoimmune
and inflammatory conditions. CCL2-LPM is designed to target and eliminate
CCR2-expressing leukocytes. In a model of glomerulonephritis, CCL2-LPM
significantly decreased the influx of leukocytes into the kidney and resulted
in less kidney mesangial cell proliferation and fibrosis. In preclinical
testing, CCL2-LPM demonstrated no adverse effects at doses up to 1.5 mg/kg
every other day for 15 doses.

About IgA Nephropathy
IgA nephropathy is the most common primary cause of kidney disease and occurs
as a result of the deposition of Immunoglobulin A in the kidney. The injured
kidney tissues secrete a variety of inflammatory mediators including CCL2.
CCL2 in the tissue causes CCR2-expressing leukocytes to become activated and
to migrate into the kidney where they perpetuate inflammation. Over time
kidney function becomes compromised and over the course of 10-20 years the
inflammation can lead to end-stage renal disease requiring dialysis or kidney
transplant. Current treatments for IgA nephropathy include blood pressure
control, diet and immunosuppressant drugs. Approximately 30 percent of IgA
nephropathy patients do not respond to current therapies.

About Osprey Pharmaceuticals U.S.A.
Osprey Pharmaceuticals U.S.A. is focused on the development of protein
therapeutics for the treatment of inflammatory and autoimmune conditions based
on the company's proprietary therapeutic platform of Leukocyte Population
Modulators (LPMs). Osprey Pharmaceuticals U.S.A. is advancing a pipeline of
proprietary LPMs, novel fusion protein therapeutics designed to selectively
and systematically neutralize disease-related leukocytes. Founded in 2008, the
company raised $11 million in the first round venture capital funding. The
financing was led by Burrill & Company with participation from Novo Nordisk
Biotech Fund, Yasuda Enterprise Development, GeneChem Therapeutics Venture
Fund, BDC Venture Capital, Inc. and Western Technology Seed Investment Fund.
Osprey Pharmaceuticals U.S.A. is based in San Francisco,
CA.www.ospreypharma.com

SOURCE Osprey Pharmaceuticals U.S.A., Inc.

Jack M. Anthony, CEO, Osprey Pharmaceuticals U.S.A., Inc., +1-415-352-6262,
anthony@ospreypharma.com; or media, Karen L. Bergman or Michelle Corral, both
of BCC Partners, +1-650-575-1509 or +1-415-794-8662, for Osprey
Pharmaceuticals U.S.A.