SolAeroMed Announces Completion of Phase IIA Proof of Concept Recruitment for S-1226

CALGARY, Alberta, November 24, 2015 – SolAeroMed Inc., dedicated to the development of novel therapeutic strategies to treat obstructive lung diseases, today announced its completion of patient recruitment for core components of its Phase IIa Proof of Concept data for its S-1226™ technology by late Fall 2015. “We are very pleased the clinical trial site has now completed testing of all patients enrolled in the study. With the patient recruitment now complete, all treatment arms of the Trial should be completed by February 2016,” said John Dennis, PhD, Chief Executive Officer of SolAeroMed.

SolAeroMed is exploring strategic options to accelerate technology development.  These options include licensing, strategic partnerships, formation of a joint venture, a sale of the Company, or venture capital financing. “This is an exciting time for SolAeroMed as we eagerly await the results of our in-human proof of concept data,” said Gareth Lewis, Chief Financial Officer of SolAeroMed. “Looking ahead, we hope to finalize a transaction with a strategic partner with the skills and expertise to help take S-1226™ through the next formal stages of clinical development. In the meantime we continue to seek investment to continue advancing S-1226™ and the other technologies in our pipeline”.

S-1226 Technology Overview

S-1226™ is SolAeroMed’s lead therapy. S-1226™ is formulated to rapidly reopen constricted, mucus plugged airways using a unique mechanism of action making it a first in class respiratory drug.  Besides being a potent bronchodilator, it should also increase the effectiveness of delivery of other inhaled respiratory drugs. The S-1226™ formulation consists of inhaled carbon dioxide (CO2) and perfluorooctyl bromide (perflubron). Inhaled delivery of S-1226™ results in an immediate relaxant effect on the patient’s constricted airways and enhances mucous clearing of blocked airways.

S-1226™ will work to improve breathing when other drugs do not. S-1226™ has a unique biophysical mechanism of action that is neither adrenergic nor cholinergic. CO2 causes temporary rapid airway dilation via epithelial receptors and vagal C-fibers while perflubron interacts with natural lung surfactant. The effect of inhaling perflubron and CO2 combination is synergistic and should result in very fast and sustained bronchodilation.

SolAeroMed completed core preclinical studies in rat and sheep animal models in2013.  SolAeroMed obtained regulatory approval by Health Canada to test in humans and in 2014 completed a Phase I dose escalating clinical trial for S-1226™ on thirty-six (36) healthy human subjects. No adverse reaction were observed or reported during the S1226 Phase 1 study using 4% CO2, 8% CO2 or 12% CO2. SolAeroMed is currently conducting a Phase IIa Proof of Concept clinical trial designed to demonstrate safety and efficacy in an asthmatic patient population under the direction of Prof Richard Leigh at the University of Calgary Foothills Hospital.

S-1226™’ target markets include all diseases where breathing is compromised, including acute bronchospasm (asthma), Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF).

Asthma and the Treatment Gap

Asthma is a chronic respiratory disease that is characterized by shortness of breath, tightness in the chest, cough and wheezing. These symptoms are due to narrowing of the airways as a result of muscle contraction and mucous plugs. In the US there are approximately 8% of adults and 9.3% of children who currently have asthma. Even with existing asthma therapeutics and treatments, there are approximately 1.8 million emergency department (ED) visits in the US annually due to asthma. Up to 25% of patients presenting to the ED do not respond to available treatments and are admitted into hospital for enhanced hospital care, which often includes intubation and mechanical ventilation. The average length of stay for admitted patients is 3.6 days at significant cost of to the healthcare system.

A gap exists in the current treatment available for acute asthma exacerbations with over 15% of patient’s not responding well to salbutamol. Pre-clinical data indicates S-1226™ could serve as a rescue therapy to address the current treatment gap.

Two asthma market niches have been identified for S-1226™ as a rescue therapy:

  • Delivery of S-1226™ to patients with acute severe asthma in a hospital emergency department setting (Emergency Department Indication). It is anticipated S-1226™ in the ED will generate annual peak sales between $208-302 million, with combined lifetime sales of $1.9-2.7 billion.
  • Delivery of S-1226™ to moderate to severe asthmatic patients as a personal, portable rescue device (Personal Rescue Indication). It is anticipated S-1226™ as a personal rescue device will generate annual peak sales between$242-340 million, with combined lifetime sales of $2.2-3.1 billion.

About Chronic Obstructive Pulmonary Disease (COPD)

COPD is an obstructive lung disease that over time makes it hard to breathe. COPD is a disease that involves inflammation and thickening of the airways. COPD is the third leading cause of death in the US, claiming the lives of 134,676 Americans in 2010. In 2011, 12.7 million adults in the US were estimated to have COPD, but COPD is considered underdiagnosed with closer to 24 million adults in the US having evidence of impaired lung function.

About Cystic Fibrosis

CF is a life-threatening, genetic disease that causes persistent lung infections and progressively limits the ability to breathe. There are approximately 30,000 people living with CF in the US (70,000 worldwide), and approximately 1,000 new cases of CF are diagnosed each year.

About SolAeroMed

SolAeroMed Inc. is a Calgary, Canada based biotechnology company dedicated to the development of novel therapeutic strategies to treat obstructive lung diseases. SolAeroMed aims to improve the quality and longevity of patients’ lives through the generation of quality biopharmaceutical technologies that are developed with “outside-the-box” thinking.  SolAeroMed aims to balance ethical and effective research and development with strategic partnering and a level of investment return to attract the resources required to develop its novel therapies.

Contact Information:

Dr. John Dennis, President and CEO

Forward-Looking Statements

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and renewed focus on our therapeutic business.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate.