Biotest AG: IgM Concentrate: Remarkable relative reduction in mortality of more than 50% in subgroup of patients
News: Biotest AG / Key word(s): Research Update
IgM Concentrate: Remarkable relative reduction in mortality of more than 50% in subgroup of patients
- Favourable new data of phase II trial with IgM Concentrate in patients with severe Community Acquired Pneumonia (sCAP) published at ISICEM Symposium
- Strong data justifies phase III development
Dreieich, March 16, 2016. Biotest announces further results of a phase II trial with IgM Concentrate (IgM enriched immunoglobulin) in subgroups at the ISICEM Symposium in Brussels (International Symposium on Intensive Care and Emergency Medicine). The randomized, double-blind, placebo-controlled phase II trial (CIGMA trial) was performed in 160 hospitalised patients with severe community acquired pneumonia (sCAP).
Community acquired pneumonia (CAP) continues to be a leading cause of death worldwide. 10% of hospitalized patients with community acquired pneumonia develop a severe form (sCAP) that requires intensive medical care. Despite treatment with antibiotics patients with sCAP still have a high mortality of 23-58% due to severe infections. IgM Concentrate is investigated as an add-on therapy in addition to standard antibiotic therapy to reduce mortality. During hospitalisation the severity of infection is constantly monitored by inflammation markers.
In the phase II study patients were randomized to two groups. One group received standard antibiotic therapy and placebo (control group). The other group received IgM Concentrate in addition to standard therapy. As already published, in the control group 28% of patients died within 28 days (28-day mortality). In the IgM Concentrate treatment group, the mortality was 22%.
Further analyses have been performed with the objective to identify the patient group that benefits most from IgM Concentrate therapy. More than 75% of patients showed a considerable elevation of inflammation markers before the start of treatment and these patients responded to IgM treatment to a greater extent. In these patients, a significant reduction in mortality was achieved and IgM Concentrate led to a relative reduction of mortality of more than 50%.
Coordinating investigator Prof Dr Tobias Welte (Head of Clinic for Pneumology, Hannover Medical School) stated, "sCAP is still a global problem because of the high mortality rates. The observed reduction of mortality is extraordinary. A successful phase III trial would be a breakthrough therapy option in this field."
In general, tolerability of IgM Concentrate was good and the safety profile as expected in the treated severely ill population. The benefit / risk evaluation remains favourable.
Biotest is the only company producing a novel polyclonal IgM enriched immunoglobulin. Biotest is evaluating different applications of this unique product for further clinical development and a phase III trial.
About CIGMA (II trial in sCAP)
About Severe Community-Acquired Pneumonia (sCAP)
About IgM Concentrate
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
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