Date: 2012-09-01
Type of information:
phase: 2
Announcement: initiation
Company: GSK (UK)
Product: GSK2586881
Action
mechanism: GSK2586881 (APN01) is a recombinant human angiotensin converting enzyme type 2 (rhACE2). ACE2 is involved in the Renin-Angiotensin System (RAS), which controls blood pressure, electrolytes and intravascular fluid volume. A key function of rhACE2 is believed to be the cleavage of Angiotensin II (Ang II) to Ang (1-7), which have opposing physiological roles. Elevated levels of Ang II are associated with vasoconstriction, inflammation, fibrosis, vascular leak, and sodium absorption. Ang (1-7) appears to be a counterregulatory protein in the RAS; associated with vasodilation, anti-proliferation, antiinflammation, and reduced vascular leak. It has been observed that levels of Ang II are increased in humans with ALI/ ARDS. It is expected that the reduction of Ang II should have a positive impact on ALI and ARDS.
The product APN01 has been developed by the austrian company Apeiron Biologics. On March 3, 2010, Apeiron and GSK have signed an exclusive licence agreement granting GSK exclusive rights to APN01.Under the terms of the agreement, the total milestone payments could reach £ 207 million (approx. € 236 million) in the event of launch in multiple indications. Apeiron will receive an up-front payment of £ 11 million (approx. € 12.5 million) in cash and equity investment and will receive royalties on net sales.
Disease: acute lung injury (ALI)
acute respiratory distress syndrome (ARDS)
Therapeutic area: Lung diseases
Country: USA
Trial
details: This phase IIa, randomized, multi-center study aims to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) (NCT01597635). This study aims to assess the safety, tolerability and pharmacodynamics of GSK2586881, a recombinant human angiotensin converting enzyme type 2 (rhACE2).
Latest
news: GSK has initiated an early phase study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The study has two parts: Part A will be an open-label investigation in five subjects. Part B will be a double-blind, placebo controlled investigation and will involve approximately 60 subjects. The study is estimated to be completed in March 2013.
