First Patient Dosed in Phase 2b Study Testing Inhaled RVT-1601 for IPF Cough

The first patient was dosed in a Phase 2b clinical trial investigating the safety and effectiveness of Respivant Biosciences’ inhalation therapy candidate RVT-1601 for idiopathic pulmonary fibrosis patients with persistent cough.

Respivant Biosciences also has launched a new website — IPFcough.com — to increase awareness about the effects of cough on the health and life of IPF patients. As a valuable resource to the patients and caregivers, the website also will support and help the IPF community, in addition to providing information about IPF.

Persistent, hard to treat, dry cough is prevalent in IPF patients, and it affects their overall health and quality of life. There is no approved therapy for IPF cough, and the ones currently used off-label do not provide the desired relief.

RVT-1601 (or PA101) is an inhalation formulation delivered directly to the lungs using the proprietary electronic nebulizer device PARI eFlow — a portable, handheld device that produces a soft mist that is easily inhaled.

The inhalation formulation contains sodium cromoglycate, which is a mast cell stabilizer (a compound that prevents immune cells called mast cells from releasing inflammatory substances like histamine). Mast cell-mediated inflammation may cause damage to lung tissues and persistent cough. Commonly used to treat asthma, RVT-1601 could prevent this damage and alleviate cough in IPF patients.

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“The assessment of a new therapy for this condition will be enthusiastically welcomed by both patients and clinicians,” Fernando Martinez, MD, said in a press release. Martinez is chief of the division of pulmonary and critical care medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center in New York.

The SCENIC Phase 2B study (NCT03864328) will assess three different doses of RVT-1601 (low, mid, and high dose) to reduce cough and improve the quality of life in IPF patients with a persistent cough. The study intends to enroll 180 patients, aged 40-89 years, who will be randomly grouped to receive either RVT-1601 or placebo for 12 weeks.

Researchers will compare the treatment and placebo groups to assess the reduction in the number of cough episodes in a day (24-hour cough frequency). As secondary outcomes, the study will evaluate changes in cough severity, and its impact on patients’ quality of life.

After 12 weeks of treatment, all patients in the study will be eligible to receive RVT-1601 for the next 12 weeks as part of an open-label treatment period.

The ongoing Phase 2B study is recruiting patients at several sites across the U.S., Canada, and Europe. More information can be found here. Topline data from the trial are expected by the end of 2020.

Results from the study also will help determine the RVT-1601 dosage for a Phase 3 trial.

Of note, a previous Phase 2a study (NCT02412020) tested RVT-1601 in 24 patients with IPF cough. Results showed that the treatment was well-tolerated, and could reduce cough frequency significantly. No significant adverse side effects were reported.

“The need for new medicines that can improve the quality of life of IPF patients is as important to patients as the effort to slow or stop the progression of the underlying disease. We’re hopeful the results from our SCENIC trial will confirm and build upon the positive results from our previously conducted Phase 2a clinical trial,” said Bill Gerhart, CEO of Respivant Sciences.