Roivant introduces new 'vant' for Bayer's inhaled hypertension medication

14 September 2024

Pulmovant is set to launch a global phase 2 trial involving 120 patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). This new development follows Roivant Sciences CEO Matt Gline’s acquisition of the rights to a pulmonary hypertension drug from Bayer for $14 million upfront. The drug, mosliciguat, is an inhaled soluble guanylate cyclase activator intended to treat PH-ILD.

Roivant, in addition to the upfront payment, has committed to potential milestone payments totaling up to $280 million to Bayer, including royalties. In conjunction with this deal, Roivant established a new subsidiary named Pulmovant to handle the licensing and further development of mosliciguat.

Pulmovant has also shared promising data from a phase 1 trial involving 38 patients with pulmonary hypertension. The trial results demonstrated a peak reduction in pulmonary vascular resistance (PVR) of up to 38%, which the biotech described as "clinically meaningful" and one of the highest reductions observed in pulmonary hypertension trials to date.

Currently, Tyvaso is the only inhaled drug specifically approved for PH-ILD. However, mosliciguat stands out due to its convenience, as it requires only one daily inhalation compared to other therapies that necessitate multiple inhalations throughout the day.

Pulmovant chose PH-ILD for the phase 2 trial due to the significant unmet medical need and the encouraging results from the phase 1b trial. According to Drew Fromkin, CEO of Pulmovant, approximately 200,000 people in the U.S. and Europe suffer from PH-ILD, and the company's decision was driven by the limited treatment options available and the strong biological rationale supporting mosliciguat's use.

Fromkin, who has significant experience in launching new biotech ventures, expressed confidence in the potential of mosliciguat and highlighted the assembly of a top-tier team, including world-class investigators and advisors, to advance the drug's development. Previously, Fromkin served as the initial CEO of Proteovant Therapeutics before its acquisition by SK Biopharmaceuticals.

Roivant's Gline emphasized the unique advantages of mosliciguat, particularly in terms of efficacy, safety, and ease of administration. He voiced optimism about the drug's potential impact on PH-ILD patients, a group characterized by severe disease, high morbidity, and limited treatment options. Gline noted the impressive data generated so far, especially regarding PVR results, and expressed belief in the drug's differentiated mechanism as an sGC activator.

Gline’s enthusiasm for Pulmovant comes after the sale of Telavant to Roche for $7.1 billion last year, a decision he admitted to having mixed feelings about earlier this year. Now, with Pulmovant and the upcoming phase 2 trial of mosliciguat, Gline and his team are poised to make significant strides in the treatment of PH-ILD.

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