Roivant's experimental lung disease drug meets goals in mid-stage study (updated)
UPDATE 1-Roivant's experimental lung disease drug meets goals in mid-stage study Updates shares, adds executive comment in bullets 3 and 4, analyst comment in bullets 6 and 7
By Sahil Pandey
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 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' UTHR.O Tyvaso and Tyvaso DPI and Liquidia's LQDA.O Yutrepia, as well as off-label use of PDE5 inhibitors — used by some in the study — such as Viatris' VTRS.O Viagra and Lilly's LLY.N Cialis.
Roivant said it has already started a late-stage study.
(Reporting by Sahil Pandey in Bengaluru; Editing by Jonathan Ananda)
((Sahil.Pandey@thomsonreuters.com;))
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