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 17%.

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 its ⁠experimental drug, mosliciguat, met the 135-patient study's main goal, reducing pressure ‌and resistance in lung ‌blood vessels by 56.3% compared with placebo at 16 weeks.

• ⁠Pulmonary hypertension associated with interstitial lung ⁠disease (PH-ILD) occurs when lung scarring damages blood vessels and forces the heart to work harder.

• Roivant's Chief Investment Officer Mayukh Sukhatme told Reuters mosliciguat's long half-life would lead to greater benefits with longer treatment, adding the company sees it as both a standalone ‌and combination treatment if approved.

• Sukhatme said ​patients have a short lifespan and mosliciguat offers the possibility of "real relief" and could help them avoid "hospitalizations, exacerbations and deaths."

• Mosliciguat also met secondary goals, helping patients walk 35.2 meters farther in a six-minute walking test compared with placebo after 16 weeks, Roivant said.

• "Before the readout, we estimated PH-ILD's risk-adjusted peak sales of $1.5 billion. With ​this data, mosli's potential is likely much greater than where we stand today, ‌as management's messaging ‌signals ⁠potential paths forward in additional indication(s)," said J.P.Morgan analyst Brian Cheng, calling the stock a "top pick."

• PH-ILD treatments include United Therapeutics' Tyvaso and Tyvaso DPI and Liquidia's Yutrepia, as well as off-label use of PDE5 inhibitors — ‌used by some in ​the study — such as Viatris' Viagra ‌and Lilly's Cialis.

• Roivant ⁠said it ​has already started a late-stage study.

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

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