Mosliciguat PHocus study succeeds, and other pharma news

PHocus study succeeds

The PHocus study, a Phase 2 trial evaluating the safety and effectiveness of the new drug mosliciguat for pulmonary hypertension associated with interstitial lung disease. (PH-ILD), reported good results. After 16 weeks of taking mosliciguat, participants’ pulmonary vascular resistance dropped by over half, their six-minute walk distance increased by 35m, and their NTproBNP level also dropped by half. Based on these very encouraging results, Pulmovant began a larger Phase 3 study (PHrontier) in the USA.

Generic riociguat in the USA

A generic form of riociguat (brand name Adempas) has been available in Canada as a treatment for pulmonary arterial hypertension and CTEPH since 2024, but not in the USA. The US is finally getting a generic version of riociguat, although it will be produced by a different manufacturer.

Seralutinib is moving forward in the USA

Back in the spring, the PROSERA study of seralutinib for pulmonary arterial hypertension narrowly failed, but was considered promising regardless. Its manufacturer, Gossamer Bio, took a few months to consider its options and address some corporate complications, but it has now submitted an application to the FDA in the USA for seralutinib.

Early CS014 trial succeeded

A phase 1 trial of the CS014 molecule in 14 participants succeeded. This pharmacokinetic (looking at what happens to the drug in the body) bridging study was intended to compare CS014 with another well-established drug, VPA. Participants took one drug, then the other, for seven days each. The company intends to proceed to a Phase II trial to assess whether CS104 is safe and effective for PH-ILD.