Bayer terminates clinical trial for hypertension due to safety concerns
pharmafile | May 13, 2016 | News story | Medical Communications, Research and Development | Bayer, clinical trial, deaths, pulmonary hypertension, riociguat, safety concerns
Bayer has terminated a Phase II trial evaluating riociguat in patients with pulmonary hypertension due to fears raised by an independent data monitoring committee (DMC) after fears were raised about a possible increased risk of death and other serious adverse events.
The patients in this trial suffered from pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). It is a rare, but serious, condition which is distinct from other types of pulmonary hypertension, belonging to group three. As there are currently no approved treatments, prognosis is poor. The estimated mortality rate is over 20% within one year.
The DMC did not identify any specific cause or common feature among the patients who died, of which the number has not yet been released. Many are said to have had more serious and advanced underlying lung disease than the study population as a whole. The patients in this trial will be continuously monitored for safety immediately after suspending treatment and for a period of at least four months.
Riociguat’s positive benefit-risk profile in its approved indications based on a large, controlled clinical database and supported by the available post market pharmacovigilance information remains unchanged.
Dr Joerg Moeller, head of global development at Bayer, says: “We understand that the need to terminate the study in PH-IIP is very disappointing for patients suffering from this disease, as well as for their doctors and healthcare providers. There is a significant unmet need for PH-IIP patients as there are no approved treatments, and finding an effective treatment remains a challenge.”
Sean Murray
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