Roivant Sciences has launched a new company whose focus is developing potential treatments for serious respiratory diseases.
RVT-1601, formerly known as PA101, is a novel formulation of cromolyn sodium, delivered using a proprietary nebulizer device that is designed to promote a more effective deposition and distribution of the compound within the lungs.
Cromolyn sodium is a medicine commonly used to treat asthma. Its mode of action to manage chronic cough is unknown, but it is believed to modulate the activity of immune cells, in particular mast cells, and how they act in the inflammatory process.
“We are excited to expedite the development of this promising therapeutic … for respiratory diseases with high unmet needs,” Mayukh Sukhatme, MD, president of Roivant Pharma, said in a press release.
The investigational therapy has already been evaluated in a placebo-controlled Phase 2a trial (NCT02412020) in 24 IPF patients with refractory chronic cough.
Participants were randomly assigned to receive either RVT-1601 or placebo three times daily for 14 days. Following this period they would stop the treatment for 14 days, after which they would switch to the opposite treatment for an additional 14-day period.
Trial data demonstrated that RVT-1601 effectively reduced cough frequency by 31.1% percent during the day, and by 29.1% over 24 hours, in treated IPF patients compared to those given placebo.
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These results were accompanied by patients reporting an improved cough-related quality of life and a lessening in cough severity, although the change was not statistically significant. This was likely related to the small size of the study, the researchers noted.
The treatment was generally well-tolerated, with no major treatment-related adverse events reported.
Respivant is planning a Phase 2b trial to identify the optimal dose for RVT-1601 that is expected to start in early 2019.
Bill Gerhart, the former CEO of Patara Pharma, is leading Respivant as its CEO. Joining him are Ahmet Tutuncu, MD, PhD, as executive vice president for clinical and regulatory affairs, and Pravin Soni, PhD, as executive vice president for development and manufacturing.
“Almost all IPF patients suffer from a dry, persistent chronic cough, and for many of them this cough can have a debilitating physical and psychosocial impact on their quality of life,” Gerhart said in a separate press release. “Based on the positive results in our Phase 2a study, we are very excited about the potential for developing the first approved therapy for this leading cause of poor quality of life in IPF patients.”
The new company’s board of directors will be chaired by Frank Torti, MD, who also is the Vant Investment Chair at Roivant Pharma. Gerhart and Myrtle Potter, who serves as the Vant Operating Chair at Roivant Pharma, will also join the board. Vants are specialty biotech companies established by Roivant to “drive greater efficiency in pharma R&D and commercialization,” according to the company’s website.