Improving the Lives of Patients Diagnosed with Pulmonary Fibrosis

Patara Pharma is a clinical-stage biopharmaceutical company dedicated to significantly improving the lives of patients suffering from pulmonary fibrosis.

Based on promising Phase 2 results, we are currently preparing to initiate a robust Phase 2b clinical trial of our lead candidate, PA101, in patients with idiopathic pulmonary fibrosis (IPF) who suffer from a dry, persistent cough refractory to currently available therapies.

Beyond treating chronic cough in IPF patients, an often debilitating symptom for many pulmonary fibrosis patients, we are also evaluating the potential of PA101 to slow progression of the underlying disease.

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 serious 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.

Impact of Chronic Cough on Patient Quality of Life

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

We believe PA101 is the first and only drug that has been demonstrated to be potentially safe and effective for treating chronic cough in patients with IPF. Patara is now preparing to initiate a Phase 2b/3 clinical trial in these patients.

Additionally, the active ingredient in PA101 has been demonstrated to have potent anti-inflammatory and anti-fibrotic effects in multiple animal models of fibrotic disease, including models of pulmonary fibrosis. We plan to further evaluate the potential for PA101 to significantly slow progression of IPF in the Ph 2b/3 trial for IPF cough,  potentially leading to initiation of clinical trials in the near future targeting the underlying disease. Although there are tow improved therapies for treating IPF, these are not projected to be utilized by more than 30-50% of IPF patients, so there is still a very significant need for new IPF therapies that can provide further treatment benefit and improve quality of life.

Approximately 75% of IPF patients suffer from chronic cough; about half are considered “refractory” because they do not respond to currently available medicines. 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.
 
75% of the approx 115,000 U.S. IPF patients have chronic cough

The US FDA recently convened a public meeting where patients with IPF described the burden of chronic cough:

- The Voice of the Patient, US FDA Public Meeting Report, March 2015
One caregiver shared that his wife would “just be soaking wet [from sweat]” after a coughing fit.
[My cough] comes with exertion… walking up a flight of stairs … putting your clothes on, bending over and tying your shoes, fixing something in the kitchen, moving around.
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.

Product

Patara’s lead drug candidate, PA101, is an inhaled therapeutic delivered directly to the lungs via a proprietary aerosol device, the PARI eFlow®. We believe delivery of PA101 directly to the lungs of pulmonary fibrosis patients is the most effective way to treat chronic cough and the underlying disease. PA101 works by inhibiting inflammatory mediators that contribute to cough and potentially slowing the progression of fibrosis. The PARI 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 PA101, thus offering the potential to optimally reduce chronic coughing and the debilitating morbidities associated with it. In clinical trials conducted in patients diagnosed with IPF, PA101 has 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, PA101/eFlow has been well-tolerated thus far, with no significant treatment-related adverse events reported.

Approximately 115,000 adults in the United States have been diagnosed with IPF, and the median survival rate is about 3-5 years after diagnosis

About

Patara Pharma is a clinical-stage biopharmaceutical company developing new therapeutics that significantly improve the lives of patients suffering from chronic inflammatory lung diseases and immune disorders.  The company’s lead candidate, PA101, is an anti-inflammatory therapeutic delivered via a proprietary aerosol device. Patara has completed a Phase 2 clinical trial with positive results and is now planning a robust Phase 2b/3 study for the treatment of IPF patients, an orphan disease with no curative therapy. Patara maintains its corporate headquarters in San Diego, CA.

Management

Bill Gerhart

Bill Gerhart

Chairman & CEO

Mr. Gerhart has more than 25 years of experience starting, financing, and building companies based on promising technologies. Prior to founding Patara, he was the President & CEO of Elevation Read More
Ahmet Tutuncu

Ahmet Tutuncu, MD, PhD

Chief Medical Officer

Dr. Tutuncu has more than 25 years of experience in academic/medical practice and the pharmaceutical industry. Prior to co-founding Patara, he was most recently the SVP and CMO of Elevation Read More
Pravin Soni

Pravin Soni, PhD

Chief Technical Officer

Dr. Soni has more than 30 years of experience developing products in a range of industries, including 20 years in senior management leading the development, manufacture, and registration of novel Read More
Matt Moran

Matt Moran

Vice President, Regulatory Affairs and Quality Assurance

Prior to joining Patara, he served as VP of Regulatory Affairs at Auspex Pharmaceuticals where he worked on the 505(b)(2) NDA submission of Austedo®, the first ever deuterated product. This Read More

Board of Directors

Bill Gerhart

Bill Gerhart

Mr. Gerhart has more than 25 years of experience starting, financing, and building companies based on promising technologies. Prior to founding Patara, he was the President & CEO of Elevation Read More
Steve Aselage

Steve Aselage

Mr. Aselage is the CEO of Retrophin, Inc. and a member of its board of directors. Prior to Retrophin, Mr. Aselage was EVP and CBO of BioMarin Pharmaceutical Inc. During Read More
Gerry Proehl

Gerry Proehl

Mr. Proehl is a Founder, President, CEO and Director of Dermata Therapeutics, LLC. Previously he was President and CEO of Santarus (SNTS), from January 2002 until January 2014, where he Read More
John Schmid

John Schmid

Mr. Schmid has over 25 years of experience in financial and senior management in the biotech industry and has raised over $900 million in private and public equity and debt Read More
Wendell Wierenga

Wendell Wierenga

Dr. Wierenga has over 30 years of pharmaceutical drug discovery and development experience in a wide range of therapeutic areas, as well as extensive board experience at private and public Read More

News

Patara Pharma’s Phase 2 Study Results for Treatment of Persistent Cough in IPF Patients Published in The Lancet Respiratory Mediciney Results for Treatment of Persistent Cough in IPF Patients Published in The Lancet Respiratory Medicine

SAN DIEGO, Sept. 20, 2017 — Patara Pharma, a clinical-stage biopharmaceutical company a clinical-stage biopharmaceutical developing therapeutics that significantly improve the lives of patients with chronic inflammatory lung diseases and immune disorders, today announced that the positive results from its phase 2 clinical trial of lead drug candidate PA101 have been ...

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A novel formulation of inhaled sodium cromoglicate (PA101) in idiopathic pulmonary fibrosis and chronic cough: a randomised, double-blind, proof-of-concept, phase 2 trial

Background

Cough can be a debilitating symptom of idiopathic pulmonary fibrosis (IPF) and is difficult to treat. PA101 is a novel formulation of sodium cromoglicate delivered via a high-efficiency eFlow nebuliser that achieves significantly higher drug deposition in the lung compared with the existing formulations. We aimed to test the ...

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Patara Pharma Announces Positive Phase 2 Results for the Treatment of Refractory Chronic Cough in Patients with Idiopathic Pulmonary Fibrosis

LONDON, Sept. 7, 2016 — Patara Pharma, a clinical-stage biopharmaceutical company developing new therapeutics that significantly improve the lives of patients with chronic inflammatory lung diseases and immune disorders, today presented positive Phase 2 results for the treatment of refractory chronic cough in patients diagnosed with idiopathic pulmonary fibrosis (IPF). ...

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Patara Pharma Appoints Biotechnology Industry Leader John Schmid to Board of Directors

Seasoned Corporate Finance Executive Adds Strategic Fiscal Expertise
SAN DIEGO, May 3, 2016 — Patara Pharma, a clinical-stage biopharmaceutical company a clinical-stage biopharmaceutical developing new therapeutics that significantly improve the lives of patients suffering from debilitating allergic and immune disorders, today announced the appointment of John Schmid to its board ...

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Patara Pharma Closes a $26 million Series A Financing and Initiates Phase II Clinical Trials to Evaluate PA101B for Refractory Chronic Cough and Indolent Systemic Mastocytosis

SAN DIEGO, Calif., October 12, 2015 – Patara Pharma, a clinical-stage biotechnology company developing treatments for debilitating allergic and inflammatory diseases and conditions, today announced the closing of a $26 million Series A preferred stock financing. Concurrent with the close of its sale of preferred stock, Patara also entered into ...

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Contact

Patara Pharma, Inc.

11455 El Camino Real Suite 460
San Diego, CA 92130 United States
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