KAER Biotherapeutics Awarded $2M NIH Grant to Develop SUPRAER® Aerosol Therapy for Patients in Respiratory Distress

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The National Heart Lung and Blood Institute of the National Institutes of Health has awarded KAER Biotherapeutics a $2M Phase II SBIR grant to produce a medical device that will enable surfactant aerosol therapy for the treatment of acute respiratory distress syndrome (ARDS).

Development of the SUPRAER® device for clinical use would be a major step in providing life-saving surfactant therapy to patients with Acute Respiratory Distress Syndrome (ARDS).

The National Heart Lung and Blood Institute of the National Institutes of Health has awarded KAER Biotherapeutics a $2M Phase II SBIR grant to produce a medical device that will enable surfactant aerosol therapy for the treatment of acute respiratory distress syndrome (ARDS).

ARDS is the sudden onset of congestion in the lungs that makes breathing extremely difficult. This syndrome is usually precipitated by pneumonia, infection in the blood stream, aspiration syndromes, smoke inhalation or major trauma. These challenges can initiate inflammation in the lungs that degrades the surfactant lining the peripheral air spaces. Normal surfactant in the periphery of the lungs generates a low surface tension that enables the lungs to expand easily when we breathe. When surfactant is not present or loses its low surface tension property, breathing becomes more and more difficult. There are no drugs approved for the treatment of ARDS. Although patients are treated with mechanical ventilation, some 40% of these patients die.

KAER has developed SUPRAER® technology to deliver large clinically relevant doses of surfactant to replace abnormal lung surfactant, which heretofore has not been possible. Frost & Sullivan was early to recognize the “game changing” nature of SUPRAER® for the delivery of aerosolized biologics to treat lung diseases in critically ill patients https://www.biospace.com/article/releases/frost-and-sullivan-recognizes-b-kaer-b-s-game-changing-innovating-aerosol-drug-delivery-methods-for-high-dose-respiratory-disease-therapeutics-/. The SUPRAER® device aerosolizes viscous solutions and suspensions of drugs and delivers them as pure solid-phase aerosols at clinically relevant dose rates up to 20 times that of present nebulizers.

Igor Gonda PhD, Founder of Respidex LLC and previously CEO of Aradigm Corporation (NASDAQ-CM: ARDM), stated “The SUPRAER® technology is uniquely suitable for point-of-care delivery of large doses of inhaled therapeutics, including viscous substances. It could therefore fill a gap that exists at present for some potentially very useful medications limited by the lack of availability of suitable delivery systems.”

In the August 2018 issue of the Aerosol Science and Technology journal, a paper entitled “Generation of High Concentrations of Respirable Solid-Phase Aerosols from Viscous Solutions” (https://www.tandfonline.com/doi/full/10.1080/02786826.2018.1488078), outlines how KAER’s patented SUPRAER ® platform technology aerosolizes liquids containing surfactant or active pharmaceutical agent(s) and delivers them as concentrated, pure, solid-phase aerosols at selected diameters between 1.5 and 5 microns. Depending on the size selected, these aerosols are suitable for deposition in the conducting airways or deep lung. The paper presents data on aerosolization and delivery of various drug surrogates including proteins, surfactant and polymers with molecular weights up to 1300 kiloDaltons, 20 times the size of the albumin protein.

Donovan Yeates PhD, CEO of KAER and principal investigator on the grant said that the transformation of the bench version of SUPRAER® into a medical device, with additional advanced features suitable for clinical use, would be a major step in providing life-saving surfactant aerosol therapy to patients with ARDS. Michael Matthay MD, the coinvestigator on the award and an international authority on ARDS at UCSF Medical Center, added that new therapeutic modalities such as SUPRAER® need to be developed and tested for their potential clinical value in an effort to help more patients recover from ARDS.

Ongoing development is supported by NHLBI Award Number R44HL127834. This Press Release does not necessarily represent the official views of the National Institutes of Health.

KAER Biotherapeutics is a preclinical respiratory drug delivery company addressing the needs of critically ill patients in clinics and hospitals who require effective aerosol therapy. KAER is initially focused on providing surfactant aerosol therapy to patients who are in respiratory distress due to an insufficiency of active surfactant in the lungs. These patients include adults with acute lung injury as well as prematurely born infants. Treatment with surfactant aerosol is projected to improve respiratory gas exchange and save lives.

KAER is seeking partners to facilitate the rapid implementation of its aerosol delivery technology for the treatment of neonatal respiratory distress syndrome, acute lung injury, idiopathic pulmonary fibrosis (IPF), TB, hospital acquired pneumonia, and other debilitating lung diseases.

CONTACT: Donovan Yeates, CEO, Kaer Biotheraeutics, dyeates(at)kaerbio(dot)com, Ph 760 480 9400, http://www.kaerbio.com

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