Phase ii a
Phase ii b
Pulmonary Hypertension is a chronic, progressive disease characterized by elevated blood pressure in the pulmonary arteries. This elevated pressure ultimately results in right ventricular failure and death.
Pulmonary hypertension (PH) is a rare lung disorder. Patients are severely ill with a life expectancy of few years after the first symptoms have occurred. In the 1980’ ies, the median survival time was 2-3 years, but based on novel treatment schedules and medication the survival time has doubled, but still very short. SER100 is indicated in patients with Group I or IV pulmonary hypertension with standard medical treatment who are admitted to hospital because of acute worsening of condition. SER100 will be administered as iv infusion without saturation dose for a period of 6 hours or more.
SER100 is ready to enter the first clinical study either in a Phase IIa study or as an adaptive Phase IIa/III (a combination of IIa and III) study in patients with PH in Group I and IV. These two groups are recognized as a rare diseases and an Orphan Drug Designation for SER100 PH will be applied for.