Bayer’s cardiovascular drug enters phase III
pharmafile | February 13, 2009 | News story | Research and Development, Sales and Marketing | Bayer, cv
Bayer Schering Pharma has begun phase III trials of riociguat for treatment of two life-threatening conditions.
Two trials will investigate its use in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and in pulmonary arterial hypertension (PAH).
Pulmonary hypertension affects more than 2.5 million people worldwide and involves an increase in blood pressure in the pulmonary artery, vein or capillaries.
It can lead to heart failure and death.
There is no known cure for PAH, which affects up to 260,000 people worldwide and is characterised by a sustained increase in blood pressure in the pulmonary artery.
Both diseases currently have only limited treatments available.
Survival time for treated patients remains short and if the positive phase II findings are replicated in phase III trials, it could represent a significant breakthrough.
Riociguat is the first member of a new class of therapeutics stimulating the enzyme soluble guanylate cyclase (sGC) – the activity of which is key to treatment.
The drug works through the same signaling pathway as the body's own nitric oxide (NO), which has the capacity to relieve symptoms.
It can also stimulate sGC independently of NO.
In phase II the drug improved exercise capacity, pulmonary vascular resistance, cardiac output and pulmonary arterial pressure, compared to baseline values.
Data was presented at the Annual Congress of the European Respiratory Society in Berlin last October, with more from the phase II study expected at the American Thoracic Society's San Diego conference in May.
The new studies – CHEST-1 and PATENT-1 – will recruit more than 700 patients.
The manufacturer says riociguat is one of the most promising product candidates it has in cardiology.
"Riociguat has the potential to overcome the disadvantages of current standard therapies," says Frank Misselwitz, head of global clinical development for cardiovascular diseases at Bayer Schering Pharma.
"We are stepping up our commitment, particularly in indications where a high unmet medical need still exists. quot;
Actelion's Tracleer (bosentan) is currently licensed to treat PAH, while Novartis has been pursuing a new indication for PAH for its existing brand Glivec (imatinib).
The drug is currently licensed in the EU and US as a treatment for gastrointestinal tumours and to treat Philadelphia-chromosome-positive chronic myeloid leukaemia.
Glivec's phase II trials last year demonstrated beneficial effects on patients with PAH but these improvements narrowly failed to reach statistical significance.
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