01—Abstract
Summary
Summary of the 8-K filed September 10, 2024. Cited figures are marked; the original filing is the authoritative source.
Roivant Sciences Ltd. (ROIV) disclosed on September 10, 2024 that it is advancing a previously undisclosed pipeline program, mosliciguat, developed at its subsidiary Pulmovant.
The company issued a press release (Exhibit 99.1) furnished under Item 7.01 of Form 8-K, presenting data from the Phase 1b ATMOS study at the European Respiratory Society Congress. Mosliciguat is described as an inhaled, once-daily soluble guanylate cyclase (sGC) activator delivered via dry powder inhaler, being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD), which the company says affects about 200,000 patients in the U.S. and Europe. In the ATMOS study of 38 patients, the company reported mean-max peak reductions in pulmonary vascular resistance (PVR) from baseline of -25.9%a, -38.1% and -36.3% for the 1.0, 2.0 and 4.0 mg doses, respectively, in the per-protocol set (N=20).
The company stated that once-daily dosing was generally well tolerated with low rates of treatment-emergent adverse events. A global Phase 2 PHocus study in about 120 PH-ILD patients is expected to begin imminently. Roivant states that Pulmovant in-licensed exclusive worldwide rights from Bayer, which received an upfront cash payment of about $14.0 millionb, with up to an additional $280 million in development, regulatory and commercial milestones, plus tiered high-single-digit sales-based royalties.
02—Key points
Key Highlights
- New pipeline program: mosliciguat, a potential first-in-class inhaled, once-daily sGC activator, developed at wholly-owned subsidiary Pulmovant
- Phase 1b ATMOS study (N=38) showed mean-max PVR reductions of -25.9%, -38.1% and -36.3% at 1.0, 2.0 and 4.0 mg doses (per-protocol set, N=20)
- Company states the PVR reductions consistently exceeded the predefined threshold of -20% for the primary outcome
- Target indication is PH-ILD, which the company says affects about 200,000 patients in the U.S. and Europe with limited or no approved treatment options
- Global Phase 2 PHocus study in approximately 120 PH-ILD patients expected to start imminently
- Licensed from Bayer: upfront cash payment of about $14.0 million, with up to $280 million in additional milestones and tiered high-single-digit sales-based royalties
- Data presented at the ERS Congress; investor call scheduled for 8:00 AM EDT on September 10, 2024
03—Questions
Frequently Asked Questions
What is mosliciguat and how does it work?
Mosliciguat is an inhaled soluble guanylate cyclase (sGC) activator delivered via dry powder inhaler and dosed once daily. Unlike sGC stimulators, the filing states it works independently of heme and NO, which the company says may allow it to retain efficacy in highly oxidative environments typical of pulmonary hypertension.
What were the efficacy results from the ATMOS study?
In the per-protocol set (N=20), mean-max peak reductions in PVR from baseline were -25.9% at 1.0 mg, -38.1% at 2.0 mg and -36.3% at 4.0 mg. A similar PVR effect was observed in the pharmacodynamic analysis set (N=37), which included participants both responsive and non-responsive to inhaled NO.
What is the commercial opportunity and next step for mosliciguat?
The company describes PH-ILD as affecting about 200,000 patients in the U.S. and Europe, with prevalence meaningfully greater than PAH and limited competition. The next step is the global Phase 2 PHocus study of approximately 120 patients, which the company says will start imminently.
What are the financial terms of the Bayer license?
Roivant created Pulmovant to in-license exclusive worldwide rights from Bayer. Bayer received an upfront cash payment of about $14.0 million, with up to an additional $280 million for development, regulatory and commercial milestones, plus tiered high-single-digit sales-based royalties.
How does the safety profile look so far?
The company reports a generally favorable safety profile across 170 participants dosed in the Phase 1 program, with once-daily dosing generally well tolerated and low rates of treatment-emergent adverse events. The company also states that direct lung delivery minimizes the risk of serious adverse effects seen with systemic vasodilators, such as worsening oxygenation.
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