Bayer/Mersk releases Adempas treatment of pulmonary hypertension Phase IV REPLACE study results

Bayer recently announced that the results of the Phase IV REPLACE study evaluating Adempas (riociguat) for the treatment of pulmonary hypertension (PAH) have been published in the international medical journal The Lancet Respiratory Medicine.

The study was carried out in adult patients with intermediate-risk PAH (World Health Organization [WHO] Group 1) who had insufficient response to phosphodiesterase 5 inhibitor (PDE5i) treatment.

Adempas is a pioneering soluble guanylate cyclase (sGC) agonist that can directly stimulate sGC and enhance its sensitivity to low levels of nitric oxide (NO).

Bayer and Merck are carrying out a global cooperation in the field of sGC modulators.

In clinical practice, a considerable proportion of patients with moderate-risk PAH cannot achieve or maintain specific treatment goals when receiving PDE5i-based treatment.

REPLACE is a prospective global, multicenter, dual-arm, randomized, controlled, open-label Phase IV study, carried out in 81 clinical trial sites in 22 countries.

The composite primary endpoint of the study is: treatment at week 24, achieving clinical improvement without clinical deterioration (death from any cause, hospitalization due to PAH worsening or disease progression) (defined as 2 of the following: 6MWD compared to baseline Increase ≥10%/≥30 meters, WHO FC I/II, NT-proBNP decrease ≥30% from baseline).

The results showed that at the 24th week of treatment, compared with the group of patients who continued PDE5i treatment, a significantly higher proportion of patients in the group of patients who transitioned to Adempas treatment reached the composite primary endpoint (achieving clinical improvement without clinical deterioration : 41% vs 20%; OR=2.

The pivotal PATENT-1 trial is a 12-week multicenter, double-blind, randomized, placebo-controlled study that evaluated Adempas in the absence of previous treatment (naïve) or an endothelin receptor antagonist (ERA ) Or prostaglandin drugs (oral, inhaled, subcutaneous) treatment (treated) in the effectiveness and safety of adult patients with PAH (n=443).

The results showed that compared with the placebo group, the Adempas treatment group showed improvements in multiple clinically relevant endpoints, including: 6-minute walking distance (6MWD) 36 meters (95% CI: 20 meters-52 meters; p<0.

In the PATENT study, compared with the placebo group, the most common adverse events (≥3%) in the AAdempas group were headache (27% vs 18%), dyspepsia/gastritis (21% vs 8%), and dizziness (20%).

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Original Source: Bayer Announces Publication of Phase IV Adempas® (riociguat) Data in The Lancet Respiratory Medicine