John Dobak, a life sciences serial entrepreneur in San Diego, said a new startup he’s leading has raised $2.66 million to advance a drug that is already approved to shrink varicose veins through early-stage clinical trials testing it in a new use —fat reduction body sculpting.
The biotech, 10xBio, announced earlier this month that the FDA had approved its application to begin clinical trials in Phase 1b/2a studies testing the unnamed injectable drug. “We’ve already dosed patients,” Dobak said Tuesday. The studies are intended to establish the safety and tissue responses of the injectable drug, said Dobak, who is the chairman of 10xBio.
“We’re looking to get on the map with this product because we’ll be looking to license it,” Dobak said.
Dobak, who has been the CEO of San Diego-based DermTech since 2012, said he started 10xBio and another biotech startup, Bio33, to develop new uses for existing therapies and technologies. Repurposing drugs already approved by the FDA follows a different protocol for regulatory approval known as 505(b)(2). By using some data from tests done for an already-approved drug, a company using this regulatory pathway can often reach an FDA decision in a fraction of the time and at far lower cost than first-time drug applications.
Dobak said he incubated the technology under development at 10xBio at the JAKK group, a San Diego entity he created to validate the concept and value of a healthcare product before making significant investments. He was previously a founder or leader at Lithera, a body sculpting company now known as Neothetics, Innercool Therapies, CryoCor, and CryoGen.
In a statement Wednesday, 10xBio said it anticipates completing initial clinical tests of its drug candidate by the end of this year.