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 have initiated 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.

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 few treatment options. Approximately 130,000 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 have a persistent chronic cough, and most of these patients do not respond to currently available medicines (refractory). IPF patients can cough up to 100 times per hour on average, which can lead to laryngeal trauma, chest pain, headache, incontinence, vomiting, anxiety, depression, and other morbidities. Additionally, this unrelenting cough contributes to breathlessness and fatigue, the other two prevalent conditions of IPF.

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 electronic nebulizer 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, 4

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.5 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.6 Importantly, the RVT-1601/eFlow combination was well-tolerated, with no significant treatment-related adverse events reported. Respivant has initiated a Phase 2b clinical trial to confirm the results of an earlier study and to identify the optimal dose for RVT-1601.

About

Respivant Sciences is a clinical-stage biopharmaceutical company developing new therapeutics for patients suffering from respiratory diseases and conditions. The company’s lead candidate, RVT-1601, is a mast cell stabilizer with pleotropic immune modulating activity delivered via oral inhalation using a proprietary electronic nebulizer device. A Phase 2a 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 has been initiated for 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 for patients with respiratory diseases that ultimately gain regulatory approval. 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.

 Pravin Soni

Tiago Girão

CFO

Mr. Girão has more than 15 years of experience in accounting, finance, and operations of U.S. and global private and public companies. He joined Respivant as CFO in April 2019. Prior to Respivant, Mr. Girão was the CFO and SVP of Operations at Cytori Therapeutics, Inc., a publicly-held biotechnology company, from September 2014 to March 2019. Prior to Cytori, he served as International Controller at NuVasive, Inc., a publicly-held medical device company, from April 2012 to August 2014. Prior to joining NuVasive, Mr. Girão served as Senior Manager, Assurance at KPMG, LLP in the U.S. from October 2004 to March 2012, as well as Ernst & Young in Brazil from October 2000 to August 2004. Mr. Girão is a certified public accountant in California and has a Bachelor’s degree in Accounting from University of Fortaleza, Brazil.

 Pravin Soni

Rod Saponjic, PhD

VP CLINICAL OPERATIONS

Dr. Saponjic has more than 25 years of drug development experience in the areas of global operations, project management, clinical operations, clinical systems and CRO Management. Prior to Respivant, he was Vice President Global Development Operations at Greenwich Biosciences, responsible for development governance structures, clinical operations, portfolio pipeline process, and supporting the NDA submission and FDA approval for Epidiolex®.  Prior to Greenwich, Dr. Saponjic was Vice President, Clinical Operations at Patara Pharma where he was responsible for execution of multiple international Phase 2 studies in the areas of chronic cough, idiopathic pulmonary fibrosis, indolent systemic mastocytosis, and uremic pruritus.  Prior to Patara Pharma, he was Vice President of Global Project Management and/or Clinical Operations at Synteract and PRA Health Sciences. Previously, he held senior management positions at biotech, CRO, and Genomics companies including: AirPharma, Alkensa Pharmaceuticals, Monitorforhire.com, Clingenix, and Quintiles.  He earned a BA in Psychology at Texas Tech University, MS and PhD in Neuroscience at Texas Christian University, and a Master’s of Business Administration from Baker 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 for patients with respiratory diseases that ultimately gain regulatory approval. 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.

News

Contact

 

Respivant Sciences, Inc.

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