InCarda Therapeutics, has raised US$30 million through the first close of a Series C equity financing. The financing was led by an affiliate of Innoviva and included existing investors Deerfield Management, HealthCap and Morningside Venture. Proceeds from the financing will be used primarily to fund the ongoing clinical development of InRhythm (flecainide for inhalation) for the treatment of a recent-onset episode of paroxysmal atrial fibrillation (PAF).
As part of the initial close of the Series C financing, InCarda has expanded its board of directors to include George Bickerstaff, co-founder and managing director of MM Dillon & Co and a member of Innoviva’s board of directors.
InRhythm is a novel inhaled therapeutic candidate designed to rapidly deliver flecainide, an antiarrhythmic agent to the heart via the lungs, to restore normal sinus rhythm (NSR) and to relieve symptoms associated with acute episodes of PAF. The therapy is being developed initially for its use under medical supervision in a hospital, emergency room or physician office, and subsequently as a portable treatment that can be self-administered by patients in a non-medically supervised setting, such as the home, to rapidly achieve conversion of PAF to NSR.
The company has successfully completed the open-label, dose-escalation Part A portion of its multinational INSTANT Phase 2 clinical trial of InRhythm in patients with recent-onset PAF and will present the results of the study at the upcoming American Heart Association’s (AHA) Scientific Sessions (13–17 November, virtual). The data to be presented will highlight the successful demonstration of the target therapeutic profile for InRhythm and the company’s selection of an optimal therapeutic dose for continued clinical development.
InCarda has commenced enrolment of the next stage of the INSTANT study, which includes a confirmatory cohort using the selected optimal therapeutic dose, and a pilot study, referred to as the patient-led sub-study. In this study, patients who already experienced a safe cardioversion with InRhythm will receive training so that they can self-administer InRhythm, under medical supervision, when another (“recurrent”) episode of PAF occurs. Additionally, InCarda is finalising plans for its multinational, pivotal Phase 3 trial of InRhythm in a medically supervised setting, which is expected to be initiated in the first half of 2021.
“This is a very exciting time at InCarda as we expect to achieve a number of critical value-creating milestones in the coming months,” said Grace E Colón, president and chief executive officer of InCarda. “This capital raise places InCarda in an excellent position to continue our progress with the InRhythm programme, while also leveraging our technical and scientific expertise to strategically expand our pipeline. We’d also like to welcome George Bickerstaff to the board and look forward to benefiting from his impressive experience in pharma to support InCarda at this particularly critical juncture in the company’s development.”
“InCarda is addressing a significant unmet medical need with a highly novel approach. I am impressed with the strength of the team and positive data to date,” said George Bickerstaff, new InCarda board member. “I believe that InCarda has identified differentiated opportunities that will dramatically improve quality of life and outcomes for patients with serious medical conditions and look forward to multiple key company milestones in 2021.”