Results of Letermovir (AIC246) Phase 2b in Prophylaxis of Human Cytomegalovirus in Recipients of Human Blood Precursor Cell Transplants Meeting Both Primary Efficacy Endpoints to be Presented at International Conferences
Initially, Dr. Holger Zimmermann will present phase 2b data on Letermovir (AIC246) for the prevention of HCMV infections in patients after human blood precursor cell transplantation at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), which will be held in London from 31st March to 3rd April 2012. Data will be presented during the session on late breaking news on Monday, 2nd April 2012 from 12:30 – 13:30 hrs.
Prof. Gerhard Ehninger will present the respective data at the EBMT (European Group for Blood and Marrow Transplantation) meeting in Geneva, Switzerland during the Session of the Infectious Disease Working Party at 03 April 2012 starting at 4pm.
Later this month on 18th April 2012 Dr. Holger Zimmermann will present an overview on Letermovir (AIC246) including clinical phase 2b data within the clinical symposium at the International Conference on Antiviral Research (ICAR) meeting in Sapporo, Japan.
“The data presented show important results indicating that Letermovir (AIC246) apart from meeting both primary endpoints for efficacy showed also a very good safety profile an thus will allow for a paradigm shift in treating patients at risk for developing HCVM infection or diseases,” said Helga Rübsamen-Schaeff, CEO of AiCuris.
Letermovir (AIC246) is an innovative, highly active and specific inhibitor of HCMV. It stems from a novel chemical class (quinazolines) and addresses a novel target (the viral terminase). Based on this new mode of action, it retains full activity also against viruses which are resistant to marketed drugs (invariably inhibitors of the viral polymerase).
Letermovir has received Orphan Drug Status in the US and EU and Fast Track Designation in the US.
Human cytomegalovirus (HCMV), a beta herpes virus, represents an important pathogen for immune compromised individuals. It is the most common virus pathogen in bone marrow and solid organ (kidney, heart, liver, lung and pancreas) transplant recipients. HCMV is the major cause of morbidity and mortality during the first six months after transplantation.
HCMV disease is characterised by fever, leucopenia (very low white blood cells) and thrombocytopenia (very low platelet numbers) with or without specific organ dysfunction. Two main strategies to prevent HCMV disease have been adopted: anti-HCMV drug prophylaxis or pre-emptive treatment of transplant recipients who are at risk or have evidence of HCMV infection upon screening.
Besides transplant recipients, newborn children are highly threatened by HCMV infections. The infection can be acquired before, during or after birth and can lead to severe neurological damage or death. Because of the side effects of presently available drugs against HCMV, it is nearly impossible to treat these children. Neither can pregnant women with an active HCMV infection be treated.
Patients with AIDS might suffer from HCMV infection or disease, once HIV has caused a massive immune deficiency. In these patients, the virus might affect various organs and may e.g. lead to blindness or life threatening pneumonia. Thanks to HAART, severe AIDS cases with HCMV disease have become rare in the Western world. But in countries where access to anti-HIV therapy is not freely available such HCMV infections, in immune-compromised patients, are more common.
Increasing evidence is accumulating that even subclinical HCMV replication may be harmful, as HCMV is a virus, which is immune-suppressive on its own. For HIV-infected individuals several recent investigations showed that even when HIV is well-suppressed by HAART, the patients may not be able to control HCMV very well and may, as a consequence, suffer from a chronic and deleterious inflammation.
Similarly, HCMV also appears to pose a risk to patients under intensive care (e.g. after heart attack, suspected sepsis or burn). In this patient group, an active HCMV infection was found to be associated with increased time of hospitalisation and increased risk for death. Furthermore, in patients being treated for an auto-immune disease by the administration of immuno-suppressive agents, it has been observed that an opportunistic HCMV infection may occur while the patients are transiently immuno-compromised.
AiCuris GmbH & Co. KG
AiCuris GmbH & Co KG is a privately held biopharmaceutical company located in Wuppertal, Germany and specializes in infectious diseases. Its activities comprise research and clinical development of innovative and resistance-breaking drugs against HCMV, Herpes, Hepatitis B, HIV and Hepatitis C as well as resistant Gram positive and Gram negative bacterial infections in hospitals. Furthermore, AiCuris' portfolio comprises two immune modulators.