Allena Pharmaceuticals has reeled in a new investor to lead its $25 million B round, which should provide enough money to get its lead drug through a multipronged midstage program and up to the threshold of Phase III. HBM stepped in to lead the pack of the Newton, MA-based biotech's original investors--Frazier Healthcare, Third Rock Ventures and Bessemer Venture Partners--with the help of another new investor, Pharmstandard International.
The money is earmarked for ALLN-177, an experimental drug for hyperoxaluria, a condition in which an excess level of oxalate is present in urine--a key building block for kidney stones. The drug is an oral oxalate-degrading enzyme designed to prevent kidney stones and other conditions that can damage the kidneys and lead to dialysis as well as transplants.
The expanded syndicate brings in a pair of international partners on what had been a primarily U.S.-focused group of backers. HBM is based in Switzerland while Pharmstandard International is the investment arm of the Russian pharma company.
The company was founded with a 2011 A round organized by Alexey Margolin and Bob Gallotto, two of the principals behind Alnara, which was sold to Eli Lilly ($LLY)--for $180 million upfront and $200 million in milestones--after the pharma giant was attracted to liprotamase. Lilly sold the drug to Anthera earlier this year, well after the FDA had rejected its market application. But once again Margolin and Gallotto find themselves very focused on developing oral drugs for metabolic conditions--in this case with a new drug that was inspired by a failed program originally worked on at Altus.
"It's a huge white space," says Margolin about hyperoxaluria, with no effective therapies and a standard of care that revolves primarily around dietary counseling. Right now, he adds, the company has proof-of-concept data available from their Phase I trial demonstrating an impact on urinary oxalate in health patients. Phase IIa, which will deliver results in a matter of weeks, is testing the drug on patients with a history of kidney stones. And the Phase IIb should get underway next spring.
The midstage program can go in several different directions, the partners say, including some of the rare diseases that the condition leads to. One potential path, notes Margolin, would be to partner on kidney stones, a major market, and go it alone in rare diseases that don't require a huge sales force. And Gallotto says the company will do plenty of CMC work while they're in the clinic so they can scale up in a way that satisfies the FDA when they come calling with an NDA.
The development plan is being executed by a core group of 10 full-timers, the partners say, augmented with the help of consultants.
"Allena has made tremendous progress in moving forward with developing a potential treatment for hyperoxaluria, a serious metabolic disease that has currently no effective pharmacologic treatments and can lead to serious kidney related complications like nephrocalcinosis, oxalate nephropathy, kidney stones and kidney transplant," said HBM's Axel Bolte, who's joining the board.
The new funds bring Allena's total raise to $43 million.
- here's the release (PDF)