LEXINGTON, Mass.--(BUSINESS WIRE)--Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that it completed enrollment in two Phase 2 clinical trials to evaluate PRM-151, its lead product candidate. The idiopathic pulmonary fibrosis (IPF) trial completed the enrollment of 117 patients while the myelofibrosis trial completed enrollment of 84 patients. Promedior plans to present the results of these Phase 2 clinical studies at appropriate medical meetings once they are completed and analyzed.
"We believe attaining these enrollment milestones speaks to both the need for new disease-modifying therapies for IPF and myelofibrosis and the promise that others see in PRM-151, Promedior's lead product candidate" said Rick Jack, Ph.D., Promedior's President and COO. "We look forward to completing these trials with the goal to bring PRM-151 forward as a potential new treatment option for patients with IPF and myelofibrosis, and ultimately for other fibrotic diseases.”
The IPF clinical trial is a Phase 2 randomized, double-blind, placebo-controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered once-a-month to subjects with IPF. The primary endpoint is forced vital capacity (FVC)% predicted change from baseline. For additional details about this clinical trial (NCT02550873), please visit www.clinicaltrials.gov.
The myelofibrosis clinical trial is a randomized, double blind Phase 2 study to determine the efficacy and safety of three different doses of PRM-151 in subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocythemia MF (post-ET MF). Subjects were randomized to one of three dose cohorts: 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg of PRM-151 administered once-a-month. The primary endpoint is bone marrow response rate, defined as the percent of subjects with a reduction in bone marrow fibrosis score by at least one grade according to WHO criteria at any time during the study. For additional details about this clinical trial (NCT01981850), please visit www.clinicaltrials.gov.
About Idiopathic Pulmonary Fibrosis
IPF is a serious,
life-limiting lung disease characterized by fibrosis and scarring of
lung tissue with a median survival of 3–5 years after diagnosis.
Replacement of normal lung tissue by fibrosis results in restriction in
the ability to fill the lungs with air and decreased transfer of oxygen
from inhaled air into the bloodstream resulting in lower oxygen delivery
to the brain and other organs. Patients with IPF most often suffer from
progressive shortness of breath, particularly with exertion; chronic,
sometimes debilitating, hacking cough; fatigue and weakness, and chest
discomfort. Currently available approved drugs slow down but do not halt
disease progression and the only curative therapy is lung transplant, an
option merely available for a small group of patients. While estimates
vary, it is believed that IPF could affect approximately 130,000
patients in the US and approximately 76,000 patients in Europe.
About Myelofibrosis
Myelofibrosis (MF), a type of
myeloproliferative neoplasm, is a serious, life-limiting cancer that is
characterized by fibrosis of the bone marrow. Replacement of the bone
marrow by scar tissue prevents the normal production of blood cells,
leading to anemia, fatigue, and increased risk of bleeding and
infection. Production of blood cells shifts to the spleen and liver
(extramedullary hematopoiesis), which become enlarged, causing severe
discomfort, inability to eat, and weakness. Symptomatic myelofibrosis
affects approximately 18,000 people per year in the US, with a median
age of 61-66.1 The only potentially curative treatment is
allogeneic bone marrow transplant, which results in reversal of fibrosis
and all symptoms, but is a realistic option for only a small number of
patients. Other currently available therapies address the symptoms, but
have minimal if any impact on the underlying fibrosis.
About PRM-151
PRM-151, Promedior's lead product candidate,
is a recombinant form of the endogenous human innate immunity protein,
pentraxin-2 (PTX-2), which is specifically active at the site of tissue
damage. PRM-151 is an agonist that acts as a macrophage polarization
factor to prevent and potentially reverse fibrosis. PRM-151 has shown
broad anti-fibrotic activity in multiple preclinical models of fibrotic
disease, including pulmonary fibrosis, myelofibrosis2, acute
and chronic nephropathy, liver fibrosis, and age-related macular
degeneration.
Phase 1a and 1b clinical studies in healthy subjects and IPF patients have demonstrated that PRM-151 was well tolerated. Additionally, a Phase 1b study in patients with IPF showed encouraging results in exploratory efficacy end points3. In an earlier Phase 2 trial in myelofibrosis, PRM-151 treatment was well-tolerated and demonstrated decreases in bone marrow fibrosis and stable or improved hematologic parameters4.
About Promedior
Promedior is a clinical stage biotechnology
company pioneering the development of targeted therapeutics to treat
diseases involving fibrosis. Fibrosis is a harmful process that occurs
in many diseases, when normal healthy tissue is replaced with excessive
scar tissue, compromising function and ultimately leading to organ
failure. Promedior's proprietary platform is based upon Pentraxin-2, an
endogenous human protein that is specifically active at the site of
tissue damage and works as an agonist, preventing and potentially
reversing fibrosis.
Promedior has successfully advanced its lead therapeutic candidate in human clinical trials, and is initially focused on rare fibrotic diseases, including idiopathic pulmonary fibrosis and myelofibrosis. Promedior is backed by leading global healthcare venture investors and has a significant intellectual property estate relating to the discoveries and applications of pentraxin-2 therapeutics.
In August, 2015, Bristol-Myers Squibb Company (NYSE: BMY) and Promedior, Inc., entered into an agreement that granted Bristol-Myers Squibb an exclusive right to acquire Promedior and gain worldwide rights to its lead asset PRM-151. Total aggregate payments to Promedior under the agreement have the potential to reach $1.25 billion, which includes an upfront cash payment for the right to acquire Promedior, an exercise fee payable if Bristol-Myers Squibb elects to exercise its right to acquire the company, and subsequent clinical and regulatory milestone payments.
For additional information about Promedior, please visit www.promedior.com.
1. Mehta, J. et al. 2014. Epidemiology of myeloproliferative neoplasms in the United States", Leukemia & Lymphoma. 55:595-600
2. Verstovsek, S. et al. 2016. Role of neoplastic monocyte derived fibrocytes in primary myelofibrosis. J. Exp. Med. 213:1723-1740.
3. Van Den Blink, B. et al. 2016. Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy. Eur. Respir. J. 47:889-97. http://erj.ersjournals.com/content/47/3/889.long
4. Verstovsek, S. et al. 2014. Phase 2 trial of PRM-151, an anti-fibrotic agent, in patients with myelofibrosis: stage 1 results. Blood. 124:713. http://www.bloodjournal.org/content/124/21/713?sso-checked=true
