WALTHAM, Mass. - New data from a Phase 1b study suggests that mosliciguat, an inhaled soluble Guanylate Cyclase (sGC) activator, may offer a significant therapeutic benefit for patients with pulmonary hypertension (PH), a condition characterized by high blood pressure in the blood vessels of the lungs. The study, conducted by Pulmovant, a subsidiary of Roivant (NASDAQ: ROIV), was presented at the European Respiratory Society (ERS) Congress in Vienna.
The ATMOS study evaluated the efficacy of mosliciguat in 38 PH patients, demonstrating a clinically meaningful mean peak reduction in pulmonary vascular resistance (PVR) of up to 38%. This reduction is noted as one of the highest seen in PH trials to date. The once-daily dosing via dry powder inhaler was well tolerated with low rates of treatment-emergent adverse events (TEAEs).
Mosliciguat's mechanism of action, which works independently of heme and nitric oxide levels, may allow for broad activity across the spectrum of PH. This could be particularly beneficial in oxidative environments typical of PH where other treatments might lose efficacy.
The Phase 1b results have prompted Pulmovant to initiate a global Phase 2 study, named PHocus, to further evaluate mosliciguat in patients with PH associated with interstitial lung disease (PH-ILD). This condition affects an estimated 200,000 patients in the U.S. and Europe, with few treatment options available.
Pulmovant's CEO Drew Fromkin emphasized the lack of treatments for PH-ILD and the strong biological rationale for advancing mosliciguat's development. The PHocus study is set to enroll approximately 120 patients and will begin shortly.
Pulmovant's development of mosliciguat aims to address the high morbidity, mortality, and poor quality of life associated with PH-ILD. The company's focus on a once-daily, inhaled therapy could represent a significant improvement over current treatments that require multiple daily inhalations.
This report is based on a press release statement from Pulmovant and reflects the presentation of the ATMOS study data at the ERS Congress.
In other recent news, Roivant Sciences (NASDAQ:ROIV) has reported key developments. The company announced promising results from the Phase 1b ATMOS study for mosliciguat, a potential new treatment for pulmonary hypertension associated with interstitial lung disease, showing significant reductions in pulmonary vascular resistance. Roivant is also preparing to commence the global Phase 2 PHocus study for mosliciguat, aiming to enroll approximately 120 patients.
Meanwhile, Roivant's subsidiary, Immunovant (NASDAQ:IMVT), reported positive outcomes from its Phase 2a trial of batoclimab, a treatment for Graves' Disease, with a 76% response rate in patients unresponsive to antithyroid drugs after 12 weeks of high-dose treatment. A pivotal trial for the treatment is expected to initiate by December 31, 2024.
On the financial front, Roivant Sciences reported $18.4 million in product revenue from VTAMA and a substantial $5.7 billion in cash and cash equivalents. Despite a slower than expected launch of Vtama for psoriasis, H.C. Wainwright maintained its 'Buy' rating for Roivant Sciences, revising its peak sales estimate for Vtama to $910 million.
Finally, Roivant has made significant clinical progress, completing enrollment for the Phase 3 study of brepocitinib in dermatomyositis and Immunovant's MG study. The company is also preparing for the launch of VTAMA in atopic dermatitis after year-end approval. These are the recent developments shaping the trajectory of Roivant Sciences in the biopharmaceutical industry.
InvestingPro Insights
Pulmovant's promising results with mosliciguat in the Phase 1b study are a positive sign for its parent company, Roivant Sciences. As investors consider the potential impact of these findings on Roivant's performance, there are several key metrics and insights from InvestingPro that could inform their decisions:
InvestingPro Data shows that Roivant Sciences has a market capitalization of $9.24 billion, reflecting the significant size of the company within the biopharmaceutical sector. The company's Price to Earnings (P/E) ratio stands at 2.08, indicating that its shares may be undervalued compared to earnings. However, the adjusted P/E ratio for the last twelve months as of Q1 2025 is -138.47, suggesting that the market is expecting changes in future profitability.
Significantly, Roivant's revenue growth has been robust, with an increase of 101.44% over the last twelve months as of Q1 2025. This indicates a strong upward trend in the company's sales, which could be a positive signal for investors looking at growth potential.
From the InvestingPro Tips, two key points stand out that may be particularly relevant to investors following the news about mosliciguat:
1. Roivant holds more cash than debt on its balance sheet, which suggests a solid financial position to fund ongoing research and development efforts, such as the PHocus study for mosliciguat.
2. The company has a high shareholder yield, which could be attractive to investors seeking returns through share price appreciation or potential future dividends once profitability is achieved.
For those interested in a deeper dive into Roivant Sciences and its investment potential, there are additional InvestingPro Tips available at https://www.investing.com/pro/ROIV. These insights could provide further context on the company's financial health and market performance, offering a more comprehensive view to support investment decisions.
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