Roivant's experimental lung disease drug meets goals in mid-stage study

Sept 8 — Roivant 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.

• 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' Tyvaso and Tyvaso DPI and Liquidia's Yutrepia, as well as off-label use of PDE5 inhibitors such as Viatris' Viagra and Lilly's 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.

(Reporting by Sahil Pandey in Bengaluru; Editing by ​Jonathan Ananda)

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