Bayer Canada has announced that Adempas (riociguat tablets) has now been approved for treating patients with pulmonary arterial hypertension (PAH).

Bayer claims that Adempas, a soluble guanylate cyclase (sGC) stimulator, is currently the only treatment approved for use in two rare types of pulmonary hypertension (PH), PAH and chronic thromboembolic pulmonary hypertension (CTEPH).

In the PATENT pivotal clinical trial, Adempas showed statistically significant efficacy in the treatment of PAH when taken alone or in combination with other PAH therapies.

The drug demonstrated improvements in exercise capacity, in a range of disease related symptoms, in the speed of disease progression and in markers of disease severity.

In the CHEST clinical study, Adempas demonstrated statistically significant clinical improvement in patients with inoperable CTEPH or persistent or recurrent CTEPH after surgical treatment at the end of 16 weeks of treatment.

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The drug showed improvements in a range of disease-related measures such as reduction in patients’ resistance to blood-flow in the arteries of the lungs, and in markers of disease severity. It also significantly improved exercise capacity measured by a six-minute walk distance (6MWD).

Long-term trials of Adempas in PAH and CTEPH are currently underway. Interim results from these studies show that safety and tolerability as well as efficacy (change in 6MWD) are sustained over one year.

Dr David Langleben from Jewish General Hospital Cardiology division said it was important to have effective options to treat complex and rare diseases such as pulmonary hypertension.

“Adempas provides us with a novel treatment option for patients that has a proven efficacy and safety profile,” Dr Langleben said. “Adempas also introduces a new class of drugs to the market, providing progress in the treatment of a disease that continues to see high mortality rates.”

Bayer has developed Adempas (riociguat), the first member of a novel class of compounds, to target a key molecular mechanism underlying PH. The drug is being investigated as a novel and specific approach to treat different categories of PH.

“Adempas provides us with a novel treatment option for patients that has a proven efficacy and safety profile.”

An enzyme found in the cardiopulmonary system, sGC is the receptor for nitric oxide (NO) and enhances production of the signalling molecule cyclic guanosine onophosphate (cGMP), which plays an important role in regulating vascular tone, proliferation, fibrosis, and inflammation, when NO binds to the enzyme.

PH is associated with endothelial dysfunction, impaired synthesis of NO and insufficient stimulation of sGC.

Adempas sensitises sGC to endogenous NO by stabilising the NO-sGC binding. The drug also directly stimulates sGC via a different binding site, independently of NO.

Adempas addresses the issue of NO deficiency by restoring the NO-sGC-cGMP pathway, leading to increased generation of cGMP.

With its novel mode of action, the drug has the potential to overcome a number of limitations of currently approved PAH therapies, including NO dependence, the company said.

According to Bayer, Adempas is the first drug that has shown clinical benefits in CTEPH, where no indicated pharmacological treatment was previously available.

Image: Ball-and-stick model of riociguat molecule. Photo: courtesy of Jynto.