Beta Bionics announced in July that it has secured $63 million in funding. The new round of funding follows a similar $63 million investment in the company that was announced in January. The company’s CEO says the two rounds of funding will likely be enough for pivotal trials to bring both its single- and dual-hormone iLet Bionic Pancreas system before the FDA for approval and to begin a commercial launch of the system in the US.
“I think we have good confidence in when we can expect to begin the final registration trial for the approval for our first product, and when we think that product might be approved and commercialized,” said Ed Damiano, Beta Bionics president and CEO, in a telephone interview with T1D Exchange Glu.
In the same month, Beta Bionics also announced a partnership with ConvaTec for that company to provide components for the iLet’s infusion sets during the clinical trials.
The funding raised this year should allow Beta Bionics to complete two pivotal trials and begin a commercial launch of the system in the US. First, a late-stage three-month trial of the iLet in insulin-only mode should begin recruitment in Quarter 2 of 2020, with an aim to submit the iLet system to the FDA for approval as an insulin-only automated insulin delivery system by the end of that year.
As that trial concludes, Beta Bionics will then kick off a longer-term late-stage trial with the iLet in its dual-hormone configuration. The reason the two trials aren’t being conducted simultaneously is because of the logistics of recruitment, Damiano said.
“We don’t want those two trials to compete with each other for subjects,” he said. “One study could cannibalize the other.”
The latter study will already be a bit more logistically challenging, and Beta Bionics is still waiting for some clarification from the FDA about some aspects of its scope. Full FDA clearance for the dual-hormone iLet functionality requires clinical proof of the safety and effectiveness of the iLet system and of the second hormone, dasiglucagon. This hormone treatment, being developed by Zealand Pharma, is an analog of human glucagon, said Damiano.
“Basically, Zealand Pharma made 7 amino acid substitutions in the 29 amino acid backbone to make a drug that is stable in water, but retains similar rapid absorption properties of human glucagon,” Damiano said.
Damiano expects that the FDA will likely require a 12-month to 24-month study of iLet use in its dual-hormone configuration in at least 100 patients. Beta Bionics has posted positive results in all of its previous trials for the safety and effectiveness of the iLet in single-hormone and dual-hormone configurations.
The plan, Damiano said, is to launch the iLet as an insulin-only delivery device in the first half of 2021. However, the device will come with the second chamber ready for use if, as he expects, the FDA will grant approval of the dasiglucagon-delivery capabilities of the iLet.
“It’s the same device. It’s one dual-chamber pump that we would launch for the insulin-only device, but we would just put a little plug, like a cap, on the insulin chamber, until it is approved for use with dasiglucagon,” he said.
Photo credit: Beta Bionics. The photo originally included this disclaimer: CAUTION: The iLet is an investigational device, limited by federal law to investigational use.