Roivant said its Phase 2 PHOCUS study of mosliciguat in pulmonary hypertension associated with interstitial lung disease hit its main goal and both of its key secondary goals, while also showing stronger results by week 24.
At week 16, mosliciguat cut pulmonary vascular resistance by 56.3% versus placebo, a placebo-adjusted change of -56.3% and the largest PVR reduction Roivant said it has seen in any randomized controlled pulmonary hypertension trial. The drug’s own PVR change was -51.3%, compared with +6.6% for placebo.
The study also improved six-minute walk distance by 35.2 meters on a placebo-adjusted basis at week 16. Mosliciguat patients gained 20.3 meters, while placebo patients lost 14.9 meters. In the same period, NT-proBNP fell 357.7 pg/ml versus placebo, a 53.2% placebo-adjusted reduction.
By week 24, those gains widened. The placebo-adjusted six-minute walk distance improvement reached 52.7 meters, and NT-proBNP fell 487.1 pg/ml, a 75.9% placebo-adjusted decline.
Roivant said the drug was well tolerated. Cough was reported in 12.1% of patients on mosliciguat, below the 18.2% seen on placebo.
The company also said its Phase 3 PHRONTIER study has now begun enrollment. Today the company's shares have moved 17.34% to a price of $40.985. If you want to know more, read the company's complete 8-K report here.
