Roivant's experimental lung disease drug meets goals in mid-stage study
ROIV•Trial details and treatment landscape
- The trial enrolled 135 patients across 87 sites in 20 countries.
- Treatment options for the condition currently include inhaled treprostinil products such as United Therapeutics' UTHR.O Tyvaso and Tyvaso DPI and Liquidia's Yutrepia, as well as off-label use of PDE5 inhibitors such as Viatris' VTRS.O Viagra and Lilly's LLY.N Cialis, which help improve blood flow through the lungs.
- Roivant has already started a late-stage study and plans to enroll about 375 patients worldwide, it said.
Mid-stage study meets main and secondary goals
Sept. 8 (Reuters) - Roivant ROIV.O said on Tuesday its experimental drug met the main goals of a mid-stage study in patients with high blood pressure associated with a type of lung disease, sending shares up about 20% in premarket trading.
Roivant has been expanding its late-stage pipeline after winning U.S. approval last month for skin and muscle disease treatment Lisraya.
- The drug developer said the experimental drug, mosliciguat, met the study's main goal, reducing pressure and resistance in lung blood vessels by 56.3% compared with placebo after 16 weeks of treatment.
- Pulmonary hypertension develops in patients with interstitial lung disease when scarring damages blood vessels in the lungs, forcing the heart to work harder to pump blood.
- Mosliciguat also met secondary goals, the company said, helping patients walk 35.2 meters farther in a six-minute walking test compared with placebo after 16 weeks.
- A blood test marker linked to heart strain fell 53.2% compared with placebo at Week 16.
- Benefits continued through Week 24, with patients walking 52.7 meters farther than those on placebo and showing further reductions in the heart-stress marker.
