Promedior, a biotechnology company that focuses on anti-tissue-scarring therapies, has lined up the patients it needs for two Phase 2 studies of PRM-151, an anti-scarring agent it is evaluating for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis.
“We believe attaining these (patient) 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,” Rick Jack, PhD, president and COO of Promedior, said in a news release. “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 (tissue-scarring) diseases.”
PRM-151 is a recombinant or gene-spliced form of the human immunity protein pentraxin-2 (PTX-2), which is active at the site of tissue damage. PRM-151 was developed to reduce tissue scarring in several diseases, including IPF, myelofibrosis and liver fibrosis.
The Phase 2 trial (NCT02550873) has enrolled 117 patients from the U.S., U.K., the Netherlands, Belgium, Switzerland, Germany, Spain, Italy, the Czech Republic, Hungary, and Poland.
The study aims to evaluate the safety and effectiveness of the PRM-151 that is given to IPF patients once a month. It will analyze several parameters related to lung function, including forced vital capacity – the amount of air a person can exhale – high-resolution chest computed tomography images, a six-minute walk test, and patient-reported outcomes over 28 weeks.
Results in IPF patients will be compared to those in patients receiving a placebo. Safety will be evaluated by analysis of treatment-related adverse events, physical exams, clinical analysis and mortality.
Promedior expects to present the trial’s results after patients have completed the treatment and the results are analyzed.
Previous Phase 1a and 1b studies showed that IPF patients tolerated PRM-151 treatment well. Another Phase 1b trial showed promising results with different doses of PRM-151 in IPF patients.
IPF is a life-threatening lung disease characterized by tissue scarring. Fibrosis prevents the lungs from being able to do an efficient job of transferring oxygen from inhaled air into the bloodstream. There is no cure for IPF. Existing treatments are aimed at alleviating symptoms.