The recruitment of patients with ARDS (acute respiratory distress syndrome) for Danish Serendex’s phase II clinical trial – GI HOPE – will begin in November 2015.
This is, according to Serendex, based on encouraging phase I data as well as ethical and regulatory approvals.
This phase II clinical trial – GI HOPE – is the first in the history of Serendex and will be carried out in up to 45 patients with pneumonia associated ARDS (acute respiratory distress syndrome) by German Universities of Giessen and Marburg Lung Center (UGMLC).
The recruited patients will be dosed with Molgradex which is Serendex‘s new proprietary nebulised formulation of recombinant human GM-CSF. The company say Molgradex is its lead candidate drug.
“We have demonstrated in our previous studies in healthy volunteers with Molgradex that the drug is well tolerated. In GI HOPE, we will examine the actual effect in patients with ARDS. We are excited about the study initiation and we hope the trial will demonstrate positive results for the benefit of ARDS patients worldwide”, says Kim Arvid Nielsen, CEO of Serendex.
CLINICAL TRIAL IN TWO PARTS
The trial is a randomized, double-blind, parallel group, multi-centre phase II study in two parts.
Part 1 is a dose escalation/safety run-in part to generate safety data on two different doses of nebulised Molgradex for assessment by an independent board monitoring the produced
data.
The monitoring board will make recommendations as to whether the dose can be increased and whether the study can proceed to Part 2 which is a parallel group comparison of two different
doses of Molgradex versus placebo, Serendex said.
The GI HOPE study will take place in Germany based centres belonging to a renowned excellence cluster of lung specialist centres (DZL) and under the supervision of primary investigator Prof. Dr. Susanne Herold from the Universities of Giessen and Marburg Lung Center (UGMLC).
The trial is expected to span a period of two years.
Serendex says that Molgradex is currently being developed for treatment of multiple severe lung diseases such as PAP (pulmonary alveolar proteinosis), ARDS (acute respiratory distress syndrome), BE (bronchiectasis), and CF (cystic fibrosis related lung infections).