UPDATED: Eyeing pivotal PhIIIs, Margolin nabs $53M crossover round for Allena

Alexey Margolin

Prepping for a pivotal Phase III program, Newton, MA-based Allena Pharmaceuticals has rounded up a few key crossover investors to help provide a $53 million round just weeks after claiming success for their lead drug in a small, single-arm proof-of-concept study.

Partner Fund Management led this C round, with Fidelity Management & Research Company and Wellington Management Company also jumping in for the first time. Allena's existing investors, Frazier Healthcare, HBM BioCapital and Pharmstandard International, also chipped in, bringing Allena's venture haul so far to $96 million.

That money has been primarily concentrated around the development of 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.

Just a few weeks ago Allena put out a statement saying that in Phase II "ALLN-177 was shown to significantly and substantially reduce mean urinary oxalate levels (mg/24 hours) from baseline (p = 0.0084). Urine oxalate decreased from a mean at baseline of 77.6 to 63.7 mg/24 hours, a decrease of 13.9 mg/24 hours (or 13.3%), and 50% of subjects had a decrease in urinary oxalate by at least 10 mg/24 hours." 

At first blush, that may not seem like a big decrease, but COO Lou Brenner notes that the risks posed by oxalate are progressive. "The ability to reduce oxalate at all has not been seen consistently with any approach," he adds. By reducing the concentration the drug can significantly reduce the risk of stones. 

"This disease is really under-appreciated," says Brenner, noting that 10% of the population will suffer from kidney stones, but little has been done to develop new therapies for it. And CEO Alexey Margolin also noted that the drug seems to be more effective specifically in high-risk patients, which the biotech will explore further in upcoming studies.

Investigators rounded up 16 kidney stone patients suffering from elevated urinary oxalate excretion, despite taking standard remedies. Now the biotech wants to go after related conditions, including oxalate nephropathy and primary hyperoxaluria, while adding new therapies to the pipeline.

Those crossover investors provide some "flexibility" to the biotech, says Margolin, but don't expect Allena to test the roiled IPO waters any time in the immediate future. The plan now is to complete Phase II studies in 2016, then start enrolling for a Phase III program. Allena should have enough cash to get into the enrollment phase, he adds, but will then have to assess how much the pivotal work will cost, and who could provide the cash for it. 

"I think by the end of next year, we should be fully prepared to start a Phase III trial," says Margolin.

Margolin, who had also worked on Alnara before selling it to Eli Lilly ($LLY), founded the company four years ago.

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