A company developing inhaled treatments for cardiovascular diseases has closed its latest round of venture capital financing.
San Francisco-based InCarda Therapeutics said Thursday that it had raised $42 million in an oversubscribed Series B round, led by Sofinnova and HealthCap, with participation from Deerfield Management. Other, existing investors in the company also participated, including Morningside Venture and Asset Management Ventures.
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The company plans to use the funding mainly for a Phase II study it recently initiated of InRhythm (flecainide), for recent-onset paroxysmal atrial fibrillation, or PAF. InRhythm’s active ingredient is a generic drug ordinarily administered as an oral tablet. It is also available in an intravenous formulation in Europe. The inhaled formulation is designed to address what the company calls an unmet need for a non-invasive, rapid-acting treatment that can be self-administered whenever episodes of PAF occur.
PAF, which affects around 34 million people globally, accounts for about 39 percent of all diagnosed cases of atrial fibrillation, according to InCarda. The company is also developing the drug for paroxysmal supraventricular tachycardia, which is estimated to affect 2.25 per 1,000 people, or about 675,000 in the US. InRhytm is in preclinical development for PSVT.
Top-line Phase I data announced last June indicated that the inhaled formulation was well-tolerated, while electrocardiogram changes suggested rapid drug delivery to the heart. The study – which enrolled healthy volunteers rather than patients – was designed to assess safety, tolerability, pharmacokinetics and pharmacodynamics. It consisted of one part with 34 participants randomized in a double-blind, placebo-controlled fashion to three doses of drug or placebo, and a crossover portion with six participants who received either inhaled or IV flecainide.
The Phase II study, dubbed INSTANT, started in May and is scheduled to complete in April 2019, according to ClinicalTrials.gov. The trial will enroll 110 PAF patients and consist of two parts: one that will be open-label and randomize patients to either a single or double dose; and another that will be blinded and randomize them at a 2:1 ratio to either the drug or placebo, given in a single or repeated dose regimen.
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As part of the Series B financing, the company has appointed to its board of directors Sofinnova partner Alan Colowick, HealthCap partner Johan Christenson and Deerfield private transactions team principal Andrew ElBardissi.
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