Seven big trailers owned by Antriabio Inc. sit parked in Boulder, Colo., holding the keys to a dream deferred: Inside is the equipment PR Pharmaceuticals Inc. (PRP) once used to manufacture microparticles for its experimental sustained-release formulation of basal insulin, Insular. Outside are the rough realities that drove it into Chapter 11 bankruptcy in 2008.

Nevan Elam, CEO and chairman of Antriabio, is now carrying the nearly crushed dream ahead. Backed by a new $10 million private placement and a well-developed microsphere insulin formulation, Antriabio expects to take its lead program, AB101, into phase I/IIa testing by mid-2015, Elam told BioWorld Today. Follow-on testing will advance the program further toward Elam’s ultimate goal of taking a piece of the $10 billion basal insulin market now dominated by products such as the once-daily Lantus (insulin glargine, Sanofi SA) and Levemir (insulin detemir, Novo Nordisk A/S).

“Those are safe and effective drugs, but in order to achieve an extended-release profile for 24 hours, they utilize a very complex process involving the alteration of the molecular structure of insulin to create an analogue,” Elam said. AB101’s formulation achieves the potential of a once-per-week profile using human recombinant insulin instead, something Elam said is a fundamental difference. “We believe that it would be very difficult to achieve this type of extended release with an analogue,” he said.

Elam’s grasp of the commercial risks of developing a diabetes therapy is likely better than most. His familiarity with PRP began during his time as head of the Pulmonary Business Unit of Nektar Therapeutics Inc. As he and his team plowed ahead on its inhaled insulin program, Exubra, Nektar’s board challenged Elam to build a metabolic disease franchise.

As he scoured the market for programs with which he could build the franchise, Elam found Fort Collins, Colo.-based PRP. The science appeared good from a distance. Then, when he looked more closely, it looked great, he said. Many road trips between Nektar’s San Carlos headquarters and Fort Collins ensued as the due diligence progressed.

“The key discovery made at PRP was where to pegylate the insulin molecule to change the solubility of insulin so that insulin could be blended evenly in either oil or water-based solutions,” Elam noted. “We are able to achieve a once-per-week release profile by mixing the pegylated insulin in a solvent with a common polymer, PLGA, to produce uniform microspheres.”

As Nekar’s confidence in PRP grew, confidence in Exubra was falling. In October 2007, Elam got a call from Pfizer, the company’s partner on Exubra. They wanted to meet and the news was not good; they were pulling the plug on Exubra.

“Nektar had to do some soul searching,” he said. As part of that process, Elam suggested the company sell its pulmonary business to a big pharma. In September 2008, he struck a deal with Novartis to sell most of Nektar’s pulmonary delivery assets to Novartis AG for $115 million. (See BioWorld Today, Oct. 22, 2008.)

PRP was out of a deal and, with the financial crisis in full swing, investors had little appetite for rescuing the company from bankruptcy. As its Chapter 11 filing transitioned into a Chapter 7 dissolution case, PRP’s intellectual property went up for sale. Eventually, Elam was able to buy the rights in late 2012, fulfilling Antriabio’s main mission: to shape the technology into a success, as AB101.

As many as 60 percent of type 2 diabetics only take oral medicines, such as metformin. Some of those patients should be on insulin, but don’t want shots. “Having a once-a-week therapy could open the gate for some of those patients to utilize basal insulin replacement therapy earlier,” Elam said.

For now, the five-person company is busy building its own strength. Sankaram Mantripragada, PRP’s former vice president of R&D, joined the company as its chief scientific officer in February, the same month Elam joined. And the company is working on a reverse stock split that will help move its OTC shares (OTCQB: ANTB) toward a planned up-listing onto Nasdaq later this year. On April 23, the company announced the formation of its scientific advisory board. It is now also ready to do early toxicity testing in two animal species during the fourth quarter, after which it expects to move into a combined phase I/IIa trial in mid-2015.

Elam said the company has “a very rare opportunity to leap-frog the standard of care.” If he’s right and AB101 succeeds, Antriabio will owe PRP’s bankruptcy estate $40 million in milestone payments, but that would be a small price to pay, he said, relative to the reward to be gained if AB101’s promise and the equipment in those trailers help the company manufacture a big win.