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Servier-Backed ARMGO Firm Takes on Heart Disease, More

By Randy Osborne
BioWorld Today Contributing Writer

CEO Sapan Shah calls ARMGO Pharma Inc. "one of biotech's better-kept secrets," but news about the company has begun to leak – not unlike the faulty calcium channels in diseased tissue that ARMGO's Phase II drug candidates are designed to fix.

Tarrytown, N.Y.-based ARMGO's partly acronym-based name derives from that of Andrew R. Marks, founder and chairman of the scientific board. The Columbia University scientist was the first to clone and characterize the calcium-regulating ryanodine receptor, establishing the leak theory in various disorders. Marks also helped develop the first drug-eluting stent.

Stabilizing the ryanodine receptor/calcium release channel is the goal of ARMGO's small-molecule candidates, dubbed Rycals: one at the Phase II stage in heart failure and cardiac arrhythmias, and one in lead optimization for muscle disorders.

The work is "old school, in the sense that it's the calcium channel and we're talking about small molecules," Shah said, but much of the work with calcium channels so far has focused on extracellular functions – regulating the flow of calcium into the cell.

ARMGO's approach suggests that getting intracellular  calcium into cytoplasm from the endoplasmic reticulum may be just as important, and “could be the underlying mechanism of diseases such as heart failure,” Shah told BioWorld Today. "No one is really looking at this particular target."

Founded in 2006 using "ARMGO" as a placeholder name, the company stayed quiet until proof-of-concept trials began with the lead compound about a year and a half ago. That's when Shah, who had been with Osaka, Japan-based Shionogi and Co. Ltd.'s U.S. group for about 10 years, came aboard.

Shionogi's U.S. office consisted of "a couple of people, a copy machine and a phone" when Shah started there, and numbered 500 staffers by the time he left, with about a half-billion dollars in revenue, having acquired Sciele Pharma Inc., of Atlanta.

"I wanted to see if I could do it again in another setting," Shah said.

ARMGO seemed like a strong bet. The company's heart program is funded through a deal with Les Laboratoires Servier that is similar, Shah said, to the one struck last year by the French pharma with Boulder, Colo.-based Miragen Therapeutics Inc. (See BioWorld Today, Oct. 19, 2011.)

Servier gets rights to heart disease and skeletal muscle Rycals in Europe and the rest of the world, but leaves U.S. and Japanese rights to ARMGO, and pays for agreed clinical development costs in ARMGO's territories.

"If we want to, we could rely on that partnership to progress progrms through approval,” Shah said, noting that “heart failure is a very tough area,” and ARMGO would like to take on a U.S. or Japanese partner for added help, though the decision likely will have to wait until Phase II outcomes are known.

"Around the middle of next year we should have a good handle on that," Shah said.

An article in Cell recently described research with mice that suggests a calcium leak in the ryanodine receptor calcium-release channel may be implicated in cognitive dysfunction, shown by way of impaired learning and memory, along with anxiety and reduced exploratory activity. The early stage work could someday mean a way forward in treating such conditions as post-traumatic stress disorder and Alzheimer's disease.

Meanwhile, ARMGO, with 21 full-time employees, hopes to start GLP studies with the skeletal-muscle candidate and open an investigational new drug application next year. In central nervous system disorders, "we have a potential lead candidate in mind, but are looking for a partner," Shah said, since the CNS side is not partnered with Servier.