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Bayer Stops Phase II Adempas Study Due to Safety Issues

Bayer AG BAYRY announced that it has terminated a phase II study on Adempas (riociguat), a soluble guanylate cyclase (sGC) stimulator, in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP), with immediate effect.

The decision followed the recommendation of an independent Data Monitoring Committee (DMC), which observed that patients dosed with Adempas were at a greater risk of death and other serious adverse events than those on the placebo arm.

However, the DMC did not identify any specific cause or common feature among the patients who died, except that many of them appeared to have more serious and advanced underlying lung disease than the entire study population. The company will continue monitoring patients in the study for safety for a period of at least four months.

We note that Adempas enjoys Orphan Drug designation in both the U.S. and the EU and is approved for use in inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgery, as well as pulmonary arterial hypertension (PAH).

In the first quarter of 2016, Adempas generated sales of $61.8 million (€56 million), up 44.2% year over year.

Meanwhile, the company is evaluating another sGC stimulator in its pipeline, vericiguat, in a phase IIb study for the treatment of chronic heart failure.

Currently, Bayer has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY, Adaptimmune Therapeutics plc ADAP and ANI Pharmaceuticals, Inc. ANIP, each  sporting a Zacks Rank #1 (Strong Buy).

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