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JAMA Publishes Positive Phase 2 Data for Promedior’s PRM-151 for Treatment Of Chronic Lung Disease

Statistically significant findings support first-in-class potential to abate progression of idiopathic pulmonary fibrosis

Lexington, Mass., June 26, 2018 — Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that positive Phase 2 results for its lead product candidate, PRM-151, were published by the Journal of the American Medical Association (JAMA) on May 20, 20181 – demonstrating strong support for its potential to abate progression of idiopathic pulmonary fibrosis (IPF). The findings were additionally presented at the American Thoracic Society International Conference by principal investigator, Ganesh Raghu, MD, Director of the Center for Interstitial Lung Disease (ILD) at University of Washington Medical Center.

IPF is a progressive lung disease with debilitating effects and poor prognosis. The five-year survival rate is 20 to 40 percent and currently available treatments do not stop the disease’s progression – leaving an unmet need for new therapeutic approaches.

The study’s objective was to determine the effect of PRM-151, a recombinant form of human pentraxin-2 protein, versus placebo on change from baseline to week 28 in mean forced vital capacity (FVC) percentage of predicted value. The randomized, double-blind, Phase 2 trial included a four-week screening period, a 24-week randomized treatment period and a four-week follow-up visit. Conducted at 18 sites in seven countries, the study included 117 patients between the ages of 40 and 80, with one group receiving intravenous PRM-151 and the other receiving a placebo. 78% of patients were receiving concurrent therapy (pirfenidone or nintedanib).

Efficacy was evaluated through pulmonary function tests including FVC, quantitative imaging analysis of high-resolution computed tomography (HRCT), a six-minute walk test and patient reported outcomes. The patients who were treated with PRM-151 every four weeks for 24 weeks exhibited a change in FVC percentage of predicted value of −2.5% compared with −4.8% with placebo – a statistically significant difference (p=.001) that indicates a slower decline in lung function.

Of note among secondary end points, the change in six-minute walk distance was −0.5 m among patients treated with PRM-151 compared with −31.8 m for those with placebo (p< .001) – a difference that falls within the range reported as clinically important in the IPF population2. According to the researchers, the lack of decline in the treatment group may suggest a potential benefit for overall functional decline.

“These Phase 2 data demonstrate the promise of PRM-151 to stabilize deterioration of lung function and improve quality of life for those struggling with IPF. Notably, stabilization in patients’ ability to function as assessed by walk distances has not been shown before. We have reason to be optimistic that this novel therapy can make a meaningful difference in patients’ daily lives,” said Dr. Raghu.

“We believe these latest findings offer the strongest support yet for the disease-modifying potential of PRM-151 in combating IPF and, ultimately, in the treatment of additional fibrotic diseases,” Bernt van den Blink, MD PhD, Senior Medical Director of Promedior. “We look forward to advancing to Phase 3 and developing PRM-151 as a viable new treatment option for patients.”

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 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, myelofibrosis3, 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, the Phase 1b study in patients with IPF showed encouraging results in exploratory efficacy end points4.  

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, 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.

Additional information is available at www.promedior.com.

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Media Contact:
Felicia Krupps
Danforth Advisors
617-418-9434
fkrupps@danforthadvisors.com

1 Raghu G, van den Blink B, Hamblin MJ, et al. Effect of recombinant human pentraxin 2 vs placebo on change in forced vital capacity in patients with idiopathic pulmonary fibrosis: a randomized clinical trial [published online May 20, 2018]. JAMA. doi:10.1001/jama.2018.6129

2du Bois RM, Weycker D, Albera C, et al. 2011. Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Am J Respir Crit Care Med. 183(9):1231-1237.

3 Verstovsek, S. et al. 2016. Role of neoplastic monocyte derived fibrocytes in primary myelofibrosis. J. Exp. Med. 213:1723-1740.

4 Van Den Blink, B. et al. 2016. Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy. Respir. J.47:889-97. http://erj.ersjournals.com/content/47/3/889.long

 

 

PTX-2

Crystal structure of human Pentraxin-2, a naturally occurring protein that is the foundation of Promedior's proprietary platform. Learn More >