According to Bayer, Adempas 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 demonstrated 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 trial, 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.
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 cinical studies 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.
Developed by Bayer, Adempas (riociguat) is 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.
By stabilizing the NO-sGC binding, Adempas sensitizes sGC to endogenous NO. 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. The drug, with its novel mode of action, has the potential to overcome a number of limitations of currently approved PAH therapies, including NO dependence.
Bayer claims that Adempas is the first drug which has shown clinical benefits in CTEPH, where no indicated pharmacological treatment was previously available.