Prothera Biologics

ProThera Biologics, Inc. is a Rhode Island-based biotherapeutics company developing Inter-alpha Inhibitor Proteins (IAIP), a class of naturally occurring human plasma proteins, as treatments for acute, severe inflammatory diseases. The company's premise is that IAIP control inflammation through multiple simultaneous mechanisms — binding complement and extracellular histones, protecting vascular endothelial cells, reducing pro-inflammatory cytokines, inhibiting proteases and dampening neutrophil activation — and also contribute to tissue repair, in contrast to conventional drug development aimed at inhibiting a single pathway. IAIP are produced primarily by the liver, circulate in blood at high concentration, and have also been detected in brain, lung, kidney, intestine and skin; healthy individuals carry high levels, while levels fall during severe inflammation as mortality rises. ProThera intends to administer IAIP as a protein replacement therapy in disease states where endogenous levels decline, following the rationale used for other blood-derived protein therapies.

Therapeutic targets named by the company include severe community-acquired pneumonia, ischemic stroke, neonatal sepsis, and the orphan indications neonatal hypoxic-ischemic brain injury and necrotizing enterocolitis (NEC), with an emphasis on neuroinflammation in the brain and inflammation of the lung. Alongside the therapeutic program, ProThera is developing IAIP as a prognostic biomarker, including a rapid, portable bedside blood test intended for use in the neonatal intensive care unit to assess which infants are at risk of progressing to neonatal sepsis or NEC and which may benefit from IAIP or other treatments such as antibiotics. The company frames the biomarker work as supporting clinical development of the therapeutic.

Founding story

Yow-Pin Lim, MD, PhD, co-founded ProThera Biologics in 2001 to develop Inter-alpha Inhibitor Proteins as both a prognostic biomarker and a novel therapeutic for acute, severe inflammatory diseases. Lim trained at the Free University in Berlin and came to the United States in 1990 for post-doctoral work in the Division of Medical Oncology at Rhode Island Hospital/Brown University under Douglas Hixson, where he generated monoclonal antibodies against plasma proteins and began research on a plasma serine protease inhibitor in inflammation and cancer.

Business model

ProThera develops IAIP-based biologics and an associated diagnostic biomarker test, and states it is positioning itself to partner both the therapeutic IAIP program and the biomarker technology with blood products and pharmaceutical companies.

Non-dilutive government research funding has supported development, including SBIR grants from the National Institutes of Health and a state matching grant; the company describes partnering its therapeutic and biomarker assets with blood products and pharmaceutical companies as its commercialization path.

Traction

ProThera reports data demonstrating that IAIP are a novel biomarker of disease severity and has completed a pilot feasibility study of its neonatal biomarker test (January 2019). It secured a $2.03 million NIH SBIR Fast Track grant in June 2019 and works with named neonatologists at Women & Infants Hospital and the University of Oklahoma College of Medicine, with the company's CEO as principal investigator.

Latest developments

In June 2019 the company announced a $2.03 million NIH SBIR Fast Track grant to develop a rapid bedside IAIP test for assessing prognosis in infants with or at risk of sepsis and necrotizing enterocolitis, following completion of a pilot feasibility study in January 2019.