With its eyes set on an IPO raise, InCarda unrolls mid-stage data backing inhaled arrhythmia drug
Working to craft an old arrythmia drug into a more user-friendly inhaled formulation, InCarda is expecting to use new Phase II data revealed Wednesday as the foundation of a potential IPO raise.
The program, repurposing the oral and IV drug flecainide into an inhalant, completed the latest cohort of its Phase II study with 50% of patients successfully converting their irregular heartbeat episodes back to normal rhythm within 90 minutes, the San Francisco biotech said. That endpoint will be the primary goal in a pivotal Phase III study, expected to begin by the end of September.
And InCarda believes the data are strong enough to get a possible IPO ready, as the biotech hired a CFO in conjunction with the news. CEO Grace Colón told Endpoints News that InCarda is in the midst of raising funds for a $70 million crossover round, and will explore a jump to Nasdaq “should it make sense.”
So far in 2021, 65 biotechs have filed or priced their IPOs, according to the Endpoints tally.
Wednesday’s data come from a study evaluating the flecainide nebulizer in a medically supervised setting, looking at individuals with recent-onset paroxysmal atrial fibrillation, or PAF. Patients have been clamoring for new treatments, Colón said, because they typically receive rate-controlling treatments in emergency rooms or other settings when they experience PAF episodes, rather than rhythm-controlling drugs.
“Things with high heart rate like 120 to 160 beats per minute, that’s just fast heart rate palpitations,” Colón told Endpoints. “But they also experience skipped beats and dizziness, like they can’t breathe. When their heart is not beating normally, they can get severe anxiety. It’s a specific type of symptoms.”
The only currently approved drug to treat these episodes, intravenous ibutilide, only has a 90-minute conversation rate of 38% to 40%, InCarda says. Not only did InCarda’s program hit the 50% mark in the Phase II study, but Colón said the mean time of conversion was just eight minutes.
Additionally, 72% of those whose heartbeats returned to normal rhythm did so within the first half hour after treatment.
Colón expects much of the new crossover to be directed toward the Phase III study, which is seeking to enroll 400 patients. Researchers are planning to randomize patients to the drug arm at a 3-to-1 ratio with that 90-minute conversion rate as the primary, and will also check out a host of secondary endpoints such as relief of symptoms, hospitalizations and time to discharge, among others.
InCarda is also conducting studies for the drug in a self-administered setting, with a currently ongoing Phase II, and is working on a trial for repeat use. Initial observations indicate that patients who respond to their first use of the candidate become “very likely” to have a second response should another episode pop up, Colón said.
There’s been lots of cultural awareness around this issue, she added, helping drive InCarda’s research forward. Heart rate and rhythm tracking technology has sprouted up everywhere in wearable products like the Apple Watch, making it even easier for patients to keep track of their PAF episodes. InCarda has had early discussions with companies developing some of these products and will continue looking for a partner should the pivotal trial work out.