BOULDER — Clinical-stage biotech firm Accera, which is developing a therapy to treat Alzheimer’s Disease, has moved from Broomfield to Boulder to become part of the latter’s bustling life-sciences scene and cash in Boulder’s international reputation as a startup haven.
Accera CEO Charles Stacey said Wednesday that the company officially made the move April 11 to 3005 Center Green Drive. Accera has about 8,000 square feet at its new digs, slightly less than it had at 380 Interlocken Crescent in Broomfield. But Stacey said the new space is more usable and will allow Accera to grow.
“We’re a little bit more in the thick of the life-sciences community,” Stacey said in a phone interview. “I think one of the other things that was key for us is Boulder definitely has more international cachet. It’s more recognizable internationally.”
Accera employs 20 people, a number Stacey expects to grow to 30 by the end of this year or early next, though some of that growth will come through remote hires as the company adopts the practice of trying to attract top life-science talent no matter where those people might be located.
Once as large as 140 employees, Accera has undergone a major transformation over the past two years.
The company is currently in the midst of a phase 3 clinical trial for its drug candidate AC 1204, which is aimed at addressing a metabolic defect in the brains of Alzheimer’s patients. That trial, which is being run entirely in the United States, is to be completed this fall, with an international Phase 3 trial to begin early next year.
Assuming those trials go as planned, Accera is aiming to apply approval from the U.S. Food and Drug Administration sometime in 2019 and have AC 1204 to market in 2020.
The company just made the shift toward new drug approval in 2014.
Founded in the early 2000s, Accera began marketing a product based on the same premise as AC 1204 in 2010. Dubbed Axona, the product was marketed as a medical food rather than a drug. Medical foods are those designated for use in the dietary management of medical conditions or diseases under supervision of a doctor. While medical foods don’t require FDA approval, the FDA does have oversight of them.
Stacey said Axona had tens of thousands of users but never gained the market traction or adoption in the medical community the firm had expected. On top of that, the FDA had sent Accera a warning letter in late 2013, contending that Axona did not meet the requirements of a medical food. Accera issued a response arguing its case and never got an official response from the FDA, Stacey said. But he said the challenging marketing and regulatory environments around medical foods led the firm to pivot toward the more-expensive route of going through phase 3 trials and gaining approval for Accera’s technology as a drug. Accera stopped marketing Axona, though it is still available to those who use it.
Accera laid off its entire commercial and sales teams in 2014 and got down to 12 people at one point. Much of last year was spent transitioning and building out the drug-development team to fulfill Accera’s current strategy.
“We feel we’ve got a really great team now,” said Stacey, who joined Accera as interim CEO in early 2014 and was named to the role in a permanent capacity last summer.
Stacey said the company will likely open an office in London next year to help oversee the international trial. An Asian office is possible as well.
Accera has raised more than $200 million since its founding. Global life-sciences investment firm Inventages, which is backed by food giant Nestle, has been an investor since 2004. Nestle itself came onboard with a large investment in Accera in 2012.
The demand for Alzheimer’s drugs is high, as there is still no cure for the disease and even the root cause has been elusive. No new drugs have gained FDA approval since 2003. Two companies working on Alzheimer’s treatments, Axovant and vTv Therapeutics, had initial public offerings last year, and Stacey said an IPO is one route Accera could go, though he declined to disclose specific fundraising plans as the company works to advance its trials.
While Accera’s current trials are aimed at treating Alzheimer’s symptoms, Stacey said Accera officials believe their technology could ultimately also be used as a mechanism for preventing the onset of the disease in patients deemed at high risk earlier in life. To gain approval for use in prevention would take further, lengthier trials in younger patients.
“We want to be able to prevent the onset of this disease, eventually,” Stacey said.