Respivant Sciences is a clinical-stage biopharmaceutical company dedicated to significantly improving the lives of patients suffering from respiratory diseases. Based on promising Phase 2 results, we plan to conduct a robust Phase 2b clinical trial of our lead candidate, RVT-1601, in patients with idiopathic pulmonary fibrosis (IPF) who suffer from a dry, persistent cough refractory to currently available therapies.

Pipeline

Disease

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 and is characterized as “idiopathic” because the cause of the disease is unknown.

IPF is a fatal and progressive lung disease with a median life expectancy of about 3-5 years, no known cure, and limited treatment options. Approximately 115,000 adults in the United States and as many as 3-5 million adults worldwide are believed to have IPF.1

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 social engagement. Cough is an independent predictor of disease progression in IPF, and therefore cough may contribute to the progression of the underlying disease.2

Approximately 75% of IPF patients suffer from chronic cough, and 40-60% of these patients do not respond to currently available medicines (refractory). These patients cough up to 100 times per hour, which can lead to laryngeal trauma, chest pain, headache, incontinence, vomiting, anxiety, depression, and other morbidities. Chronic cough is one of the most significant contributors to poor quality of life in IPF and may also be an independent predictor of disease progression.

The FDA convened a public meeting with IPF patients who describe the burden of chronic cough:

– The Voice of the Patient, US FDA Public Meeting Report, March 2015

"My cough was really so deep that it felt like I broke my ribs, and my ribs became so cramped that I couldn't even twist [my body]"

"On my worst days, coughing will wipe you out for an entire day … Physically, you're exhausted."

One caregiver shared that his wife would ‘just be soaking wet' from sweat after a coughing fit.

Product

Respivant’s lead drug candidate, RVT-1601, is an inhaled therapeutic delivered directly to the lungs via a proprietary aerosol device, the PARI eFlow®. We believe delivery of RVT-1601 directly to the lungs of pulmonary fibrosis patients is the most effective way to treat chronic cough and potentially the underlying disease. RVT-1601 works by inhibiting inflammatory mediators that contribute to cough and as well as to the progression of fibrosis.3

The eFlow® is a portable, handheld device that produces a soft mist which patients can conveniently inhale. This delivery system achieves high lung deposition and distribution of RVT-1601, thus offering the potential to optimally reduce chronic cough and the debilitating morbidities associated with it.4 In a Phase 2 clinical trial conducted in patients diagnosed with IPF, RVT-1601 achieved a statistically significant and clinically meaningful reduction in cough frequency, which was supported by positive trends in cough severity and quality of life as assessed by patients in the study. Importantly, the RVT-1601/eFlow combination was well-tolerated, with no significant treatment-related adverse events reported. Respivant plans to initiate a Phase 2b study to identify the optimal dose for RVT-1601.

About

Respivant Sciences is a clinical-stage biopharmaceutical company developing new therapeutics with the potential to significantly improve the lives of patients suffering from respiratory diseases and conditions. The company’s lead candidate, RVT-1601, is a mast cell stabilizer with pleotropic immune modulating properties delivered via oral inhalation using a proprietary aerosol device. A Phase 2 clinical trial was completed with positive results in IPF patients with chronic cough, an orphan disease with no curative therapy, and now a robust Phase 2b study is planned for the treatment of this often-debilitating condition.

Leadership

Bill Gerhart

Bill Gerhart

CEO

Mr. Gerhart is a biotech entrepreneur with a successful track record of developing important new medicines that ultimately gain regulatory approval to benefit patients with respiratory diseases. Prior to Respivant, Mr. Gerhart was a founder and the CEO of Patara Pharma from 2014 to 2018, which conducted the early development of Respivant’s RVT-1601. Prior to Patara, he was the President & CEO of Elevation Pharmaceuticals, a San Diego-based biotech he co-founded in 2008 that developed a new inhaled therapy for patients with severe chronic obstructive pulmonary disease (COPD). Elevation was acquired in 2012 by Sunovion, a subsidiary of Dainippon Sumitomo Pharma, and in 2017 the FDA approved this new therapy, now marketed as Lonhala® Magnair® – the first nebulized LAMA for COPD patients. Prior to Elevation, Mr. Gerhart was the President and CEO of Mpex Pharmaceuticals from 2002 to 2007, a company he co-founded to discover and develop new antibacterials for the treatment of serious infections, including Quinsair®, an inhaled antibiotic now approved in Europe and Canada for the treatment of cystic fibrosis. Mr. Gerhart is also the Vice-Chair of the Board of Trustees at the Sanford Burnham Prebys Institute. He received his MBA from Harvard Business School and his BBA degree from Baylor University.

Ahmet Tutuncu

Ahmet Tutuncu, MD, PhD

EVP, CLINICAL AND REGULATORY

Dr. Tutuncu has more than 25 years of experience in academic/medical practice and the pharmaceutical industry. Prior to Respivant, Dr. Tutuncu was most recently a co-founder and the CMO of Patara Pharma. Prior to Patara, he was co-founder and CMO of Elevation Pharmaceuticals, responsible for the execution of multiple Phase 2 clinical trials for a new therapy to treat severe COPD. Prior to Elevation, Dr. Tutuncu was VP of Medical Affairs at Verus Pharma where he was responsible for all clinical development activities targeted at asthma, anaphylaxis and other atopic conditions. Prior to joining Verus, Dr. Tutuncu was Director of Corporate Medical Affairs at SkyePharma where he led the clinical development of pulmonary programs including budesonide, formoterol and FlutiForm®. Previously, Dr. Tutuncu held positions of increasing responsibility in clinical development and drug safety at Alliance Pharmaceuticals. He received his PhD in Respiratory Pathophysiology from Erasmus University Rotterdam and his MD from the University of Istanbul where he was also an attending physician and faculty member specializing in intensive care medicine.

 Pravin Soni

Pravin Soni, PhD

EVP, DEVELOPMENT AND MANUFACTURING

Dr. Soni has more than 30 years of experience developing innovative products, including 20 years in senior management leading the development, manufacture, and registration of novel drug, device, and combination medical products. Prior to Respivant, Dr. Soni was most recently co-founder and CTO of Patara Pharma. Prior to Patara, he was SVP and CTO of Elevation Pharmaceuticals where he was responsible for leading the development of a novel inhalation device/drug combination for the treatment of severe COPD. Prior to Elevation, he was VP of Product Research and Development at Alexza Pharmaceuticals where he led the development of a novel inhalable drug delivery system, the Staccato inhaler, for systemic drug delivery via the deep lung. Prior to Alexza, Dr. Soni was VP of Engineering at Cygnus where he led the development of the first commercial non-invasive, automatic, and continuous blood glucose monitoring system, the GlucoWatch Biographer, as well as a 7-day contraceptive transdermal system that was marketed by Johnson & Johnson as Evra. Dr. Soni graduated with a B.Tech degree in Chemical Engineering from LIT Nagpur and earned a PhD in Polymer Science and Engineering from Case Western Reserve University.

Board of Directors

Bill Gerhart

Bill Gerhart

CEO

Mr. Gerhart is a biotech entrepreneur with a successful track record of developing important new medicines that ultimately gain regulatory approval to benefit patients with respiratory diseases. Prior to Respivant, Mr. Gerhart was a founder and the CEO of Patara Pharma from 2014 to 2018, which conducted the early development of Respivant’s RVT-1601. Prior to Patara, he was the President & CEO of Elevation Pharmaceuticals, a San Diego-based biotech he co-founded in 2008 that developed a new inhaled therapy for patients with severe chronic obstructive pulmonary disease (COPD). Elevation was acquired in 2012 by Sunovion, a subsidiary of Dainippon Sumitomo Pharma, and in 2017 the FDA approved this new therapy, now marketed as Lonhala® Magnair® – the first nebulized LAMA for COPD patients. Prior to Elevation, Mr. Gerhart was the President and CEO of Mpex Pharmaceuticals from 2002 to 2007, a company he co-founded to discover and develop new antibacterials for the treatment of serious infections, including Quinsair®, an inhaled antibiotic now approved in Europe and Canada for the treatment of cystic fibrosis. Mr. Gerhart is also the Vice-Chair of the Board of Trustees at the Sanford Burnham Prebys Institute. He received his MBA from Harvard Business School and his BBA degree from Baylor University.

Myrtle Potter

Myrtle Potter

Myrtle Potter was appointed Vant Operating Chair for Roivant Pharma in July 2018. In this role, she is expected to serve as one of two Roivant representatives on the boards of biopharmaceutical companies in the Roivant family. Ms. Potter previously served as President and Chief Operating Officer of Genentech during a pivotal period of the company’s growth. Under her leadership, Genentech achieved record sales and earnings growth each year. Prior to Genentech she was president of Bristol-Myers Squibb’s U.S. Cardiovascular and Metabolic business. She is a graduate of the University of Chicago and serves on the university’s board of trustees. She also serves on the boards of Rite Aid and Liberty Mutual Insurance Group, and previously served on the boards of Amazon, Express Scripts, and Medco Health Solutions.

Frank Torti

Frank Torti, MD

Dr. Torti joined Roivant in August 2018 from New Enterprise Associates (NEA), a leading venture capital firm where he served as partner. At NEA, Dr. Torti managed early and growth-stage investments in numerous healthcare companies that were responsible for the development and commercialization of new drugs and medical devices important to clinical medicine today. Prior to joining NEA in 2007, Dr. Torti was a researcher at the Duke University Center for Clinical & Genetic Economics. Dr. Torti received his M.D. from the University of North Carolina School of Medicine and his M.B.A. with distinction from Harvard Business School.

Contact

 

Respivant Sciences, Inc.

11455 El Camino Real, Suite 460
San Diego, CA 92130 United States
+1 (858) 436-1624
Info@Respivant.com