Looking to repurpose an old drug to treat irregular heartbeats, InCarda raises $30M in first Series C close
A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.
The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.
Wednesday’s financing was led by an affiliate of Innoviva and also included existing investors Deerfield Management, HealthCap and Morningside Venture.
InCarda is studying how the experimental candidate, which repurposes the old oral and IV drug flecainide into a nebulizer, can be used in a medically supervised setting as well as a self-administered form, CEO Grace Colón told Endpoints News. The former has completed an open-label Phase IIa study, with data coming in November, while the latter recently began a Phase IIb.
Colón laid out the timeline for all the trials as follows — the medically supervised studies will enter a Phase III in the first half of next year, with a readout expected in early 2022; and the self-administered Phase IIb will run in parallel through the second half of 2021, with a Phase III to begin after that’s been completed.
Ultimately, InCarda is seeking to close the gap between heart rate control and heart rhythm control medicines. When patients typically go to the hospital for atrial fibrillation, they’re given drugs that slow the beating of their hearts but may still leave the chambers beating out of sync.
“Patients are typically given drugs like a beta blocker or calcium channel blocker, which allows them to quickly feel somewhat better but they’re still skipping beats,” Colón said. “Typically they’re kept in the ER to see if they convert spontaneously, but two-thirds of the patients in the ER end up getting admitted and kept overnight.”
There are three stages of chronic AF, Colón noted, and patients may sometimes be reluctant to seek treatment until the disease progresses. At first, the heart may only be arrhythmic for a few minutes to a few days at most, and those episodes typically resolve themselves. Patients require intervention once they reach the persistent stage, as there’s no treatment once the condition becomes permanent.
Right now, the rate control medicines given in hospitals stop only the noticeable symptoms and can contribute to the progression of AF, Colón said. Whereas a rapid heart rate causes palpitations, arrhythmia can lead to dizziness and stroke if left untreated.
“It’s like rebooting your computer,” Colón said. “The signals that generate the atrial fibrillation are just not receiving the signals to beat correctly, it’s almost like they’re getting scrambled when they go into arrhythmia. When you treat them with an antiarrhythmic, it resets the heart.”
Reformulating flecainide into an inhalable substance proved to be a manageable task for InCarda’s founders, who Colón says are experts in inhalation and had previously worked on creating inhalable insulin treatments for diabetes. The drug, which has a narrow therapeutic window, has fared well safety-wise so far as it’s absorbed quickly by the pulmonary vein and atrium and then expunged before it can get too toxic. Patients taking oral and IV flecainide most commonly experience hypotension.
If all goes according to plan, InCarda could launch the product in the medically supervised field as soon as 2023, Colón said. But she emphasized that the company has to get through its trials first and foremost.
“This is especially exciting at a time when more and more patients are using mobile, wearable and portable devices for their arrhythmia,” Colón said. “We feel that all of that excitement and awareness that’s out there is great for patients, however they don’t have immediate clinical utility, and that’s something that we’ll be able to provide.”