What Are Acquired Plasminogen Deficiencies – IPF
The corporation will initiate a series of additional clinical programs to demonstrate the potential efficacy of Ryplazim’s™ (plasminogen) to address unmet medical needs and fatalities associated with “acquired plasminogen deficiencies”. Such acquired plasminogen deficiencies occur in some medical conditions such as ARDS or in diabetic patients with uncontrolled and elevated blood glucose. ARDS affects 190,000 Americans every year with a 30%-40% mortality rate, and it is documented in literature that one of the complications in these patients is the accumulation of fibrin / fibrous material in the lungs. Preclinical models have demonstrated that treatment with plasminogen helps overcome the accumulation of fibrin.
In a gold-standard animal model proven to emulate pulmonary fibrosis in humans, Prometic’s Ryplazim™ (plasminogen) performed favorably compared to recently approved IPF drugs to treat this condition (see figure below). Ryplazim™ (plasminogen) significantly reduced tissue scarring (% collagen) in the lungs that was observed in non-treated animals, indicating the potential for providing clinically significant improvement and stabilization in lung function.
Prevalence of IPF:
IPF affects about 130,000 people in the United States, with about 48,000 new cases diagnosed annually. Approximately 40,000 people die each year with IPF, a similar number of deaths to those due to breast cancer. The 5-year mortality rate for patients with IPF is estimated to range from 50% to 70%. ARDS affects 190,000 Americans every year with a 30%-40% mortality rate.
Clinical Trials – Development Stage:
Plasminogen reduces fibrosis in the gold standard bleomycin mouse model and also has shown promise in reducing lung injury in animal models of acute lung injury. Study designs are being explored to determine if plasminogen will be effective in reducing acute lung injury in acute exacerbations of IPF which remains a significant unmet medical need.
The Corporation plans to initiate clinical programs in North America for the potential use of Ryplazim™ (plasminogen) for the treatment of acute exacerbations in patients with ARDS or IPF. Ryplazim™ (plasminogen) was granted Orphan Drug and Fast Track Designations by the FDA for the treatment of IPF.