- Statistically significant reduction in cough frequency observed among IPF patients after 14 days of treatment in completed Phase 2a trial
BASEL, Switzerland and SAN DIEGO, Calif., September 4, 2018 /PRNewswire/ — Roivant Sciences today announced that it has completed a transaction with Patara Pharma to acquire global rights to PA101 (now called RVT-1601), a novel formulation of inhaled cromolyn sodium delivered through a proprietary nebulizer device designed to yield high lung deposition and distribution, as well as related assets owned by Patara Pharma.
In a completed Phase 2a trial, RVT-1601 demonstrated a statistically significant reduction in daytime and 24-hour cough frequency among idiopathic pulmonary fibrosis (IPF) patients versus placebo after 14 days of treatment. This reduction was supported by positive trends in cough-specific quality of life and cough severity, as assessed by patients in the study.
The therapy was well tolerated, with no significant treatment-related adverse events reported in clinical studies to date. Roivant plans to initiate a Phase 2b study to identify the optimal dose for RVT-1601.
“We are excited to expedite the development of this promising therapeutic,” said Mayukh Sukhatme, M.D., President of Roivant Pharma. “It will form the foundation for a new Vant at Roivant Pharma with an experienced leadership team focused on advancing innovative treatments for respiratory diseases with high unmet needs.”
About Idiopathic Pulmonary Fibrosis and Chronic Cough
Pulmonary fibrosis is a family of lung diseases characterized by scarring and thickening of lung tissue leading to an irreversible loss of lung function and reduced life expectancy. Idiopathic pulmonary fibrosis (IPF) is the most common interstitial lung disease. IPF is a serious and progressive lung disease with a median life expectancy of about 3-5 years, no known cure, and limited treatment options. As many as 115,000 adults in the United States and as many as 3-5 million adults worldwide are believed to have IPF.
Most patients diagnosed with pulmonary fibrosis suffer from a dry, non-productive cough that interrupts their daily living and significantly contributes to poor quality of life. Chronic coughing (lasting more than 8 weeks) can have a debilitating physical and psychosocial burden, exacerbate concomitant respiratory disease, cause loss of sleep, and reduce mobility.
About Roivant Pharma
Roivant Pharma is the biopharmaceutical business unit of Roivant Sciences. Roivant Pharma is focused on end-to-end biopharmaceutical company creation, launch, and oversight. Roivant Pharma companies include Myovant, Axovant, Arbutus, Urovant, Enzyvant, Dermavant, Genevant, Metavant, Immunovant, and Altavant.
About Roivant Sciences
Roivant is focused on rapidly developing innovative medicines through a novel form of industrial organization. We build Vants – nimble, entrepreneurial biotech companies with a unique approach to sourcing talent, aligning economic incentives, and deploying technology to drive greater efficiency in R&D and commercialization. The goal of our model is to ensure that important medicines rapidly reach patients who suffer from serious diseases.
For more information, please visit www.roivant.com.