Bayer and Merck recently presented positive results from five data sets that evaluated the clinical benefits of Adempas (riociguat) for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH).
The findings were presented at the 11th annual World Congress of the Pulmonary Vascular Research Institute (PVRI) Jan. 26-29 in Miami.
“Although the medical community has made significant progress in the diagnosis and treatment of pulmonary arterial hypertension, there remains an unmet need,” Aleksandra Vlajnic, vice president of medical affairs at Bayer, said in a press release. “These data provide pulmonologists and cardiologists with insights into these often underdiagnosed and undertreated conditions.”
Bayer presented data at the CHEST Annual Meeting in October 2016 from three clinical trials: PATENT-2 (NCT00863681), PATENT-1 (NCT00810693), and the Phase 3 RESPITE study (NCT02007629), which evaluated the effectiveness, safety, and tolerability of Adempas at different doses for the treatment of PAH.
Bayer and Merck presented several studies at the PVRI congress. Data from the RESPITE study was shown in an oral presentation titled, “The relationship between nitric oxide pathway biomarkers and response to riociguat in the RESPITE study of patients with pulmonary arterial hypertension (PAH) not reaching treatment goals with phosphodiesterase 5 inhibitors (PDE5i).”
RESPITE is an open-label study analyzing whether PAH patients who did not respond to treatment with phosphodiesterase-5 blocking drugs, such as Adcirca (tadalafil), could benefit by switching to Adempas. Early data indicated that the switch could improve patients’ heart function and quality of life.
In the presentation titled “Effects of riociguat in treatment-naive vs. pretreated patients with pulmonary arterial hypertension (PAH): 2-year efficacy results from the PATENT-2 study,” the companies provided data from PATENT-2, an open-label Phase 3 long-term extension trial of Adempas in PAH patients who completed the PATENT-1 trial.
The PATENT-2 study is following patients for four years and 10 months, comparing the effectiveness of Adempas in patients previously treated for PAH and those who were never treated.
The presentation “Effects of riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) versus persistent/recurrent pulmonary hypertension (PH) after pulmonary endarterectomy (PEA): 2-year efficacy results from the CHEST-2 study,” focused on data from the CHEST-2 trial (NCT00910429). CHEST-2 was a long-term extension trial of the 16-week CHEST-1 study (NCT00855465) which collected additional information to evaluate the safety and tolerability of Adempas in patients with CTEPH.
The presentation, “Riociguat for the treatment of patients with chronic thromboembolic pulmonary hypertension (CTEPH): Application of criteria for satisfactory clinical response to CHEST-1 and CHEST-2 populations,” provided data from CHEST-1 and CHEST-2 trials. CHEST-1 evaluated the effectiveness and safety of oral Adempas (1 mg, 1.5 mg, 2 mg, or 2.5 mg, 3 times a day) in patients with CTEPH.
Their final presentation, “Application of the criteria for satisfactory clinical response to riociguat treatment of patients with pulmonary arterial hypertension (PAH) in PATENT-1 and PATENT-2,” provided data from the PATENT-2 trial.
Adempas is the first of a novel class of stimulators of soluble guanylate cyclase (sGC), an enzyme responsible for vasodilation and lowering of blood pressure, and the only receptor of nitric oxide in the body. The drug helps arteries relax to increase blood flow and decrease blood pressure. Adempas is developed and commercialized as part of a collaboration between Bayer and Merck in the field of sGC modulation.
The U.S. Food and Drug Administration (FDA) approved Adempas for the treatment of both CTEPH and PAH in October 2013. Five months later, Adempas was approved by the European Commission for the treatment of the same clinical indications.