Posts Tagged validated endpoints
Delivering Drugs Straight to the Heart – InCarda’s Acute Atrial Arrhythmia Treatment
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on December 17, 2014
Narsi Rangachari, co-founder of InCarda Therapeutics talked about InCarda’s novel approach to delivering drugs straight to the heart.
Approximately 20 million patients a year in the US, experience one or more forms of acute cardiac conditions. Current therapies to treat acute conditions are not optimal. They are slow, have not effective presenting higher risk. Current therapies also seem to cause a great deal of patient discomfort, resulting sometimes in poor quality of life, frequent and continuing ER visits, and extended hospital stay. Cardiac conditions add a tremendous burden to the overall healthcare costs. Cardiac arrhythmias rank as number 7 among the top 10 reasons for hospitalizations. There are little to no acute interventions in treating patients with atrial arrhythmias.
Atrial Fibrillation (also called Afib or AF) is a serious but non-life threatening condition that causes irregular and often-rapid heartbeats and many a time where the patient experiences debilitating symptoms. Global prevalence of AF is over 34 million and growing, with more than 5 million Americans estimated to suffering from the disease. Oral tablets approved for chronic treatment of AF are 30-50% effective, have very slow onset and are generally not suited for acute intervention. Few of the new drugs have made it to the market and these have not proven to be safe and effective. Ablation is an expensive and invasive procedure requiring repeat procedures, require hospital stays and are often associated with serious adverse events.
InCarda’s patented technology focuses on targeting the drugs to the heart via the lungs, said Rangachari. He spoke about a variety of technologies available to deliver drugs to and through the lungs. These included portable nebulizers, dry powder aerosols and breath controlled pulmonary delivery. The benefit of inhalation in treating atrial arrhythmias is that it delivers a “first pass” to cardiac tissue, delivering a bolus of drug directly to regions of the heart where stimuli for acute atrial arrhythmias arise. This permits rapid onset, lower off-target tissue exposure of the drug and – importantly – can be self-administered by the patient. InRhythm currently under development to treat widespread symptomatic atrial arrhythmia conditions like paroxysmal atrial fibrillation (PAF) uses approved drugs in a new dosing paradigm. InCarda has developed a de-risked approach by employing well studied, first line drugs, with long histories of efficacy and safety. In addition, the Company is using validated endpoints with established clinical assays and using commercially available inhalation devices for clinical evaluation. It was a very interesting talk and was followed by Q&A.
PS – See similar article on Pearl Therapeutics http://bit.ly/NnPhwI , a tiny company that focused on inhalation drug delivery for conditions like asthma and COPD and was bought by Astra Zeneca for $1.15 Billion.