Ironwood Begins Early Clinical Trials of Possible MD Therapy

by Margarida Azevedo, MSc | November 10, 2015

Ironwood Pharmaceuticals, Inc., recently announced the beginning of a Phase Ib clinical trial of IW-1973 and a Phase Ia clinical trial of IW-1701, both soluble guanylate cyclase (sGC) stimulators from a wide-ranging, pharmacologically distinct portfolio of sGC composites discovered by the company. The clinical results intend to determine dose selections along with the main indications for the scheduled Phase II sGC clinical program, which will focus on conditions with clinical unmet needs such as muscular dystrophies.

SGC is an enzyme found inside cells throughout the body and modulates the levels of the second messenger cyclic guanosine monophosphate (cGMP), a signaling molecule that regulates many physiological changes. SGC stimulators may be relevant for the treatment of a broad range of diseases including muscular dystrophy.

“Soluble guanylate cyclase is a fundamental regulator of blood flow, inflammation and fibrosis, which endows sGC stimulators with broad therapeutic potential in cardiovascular diseases, fibrotic diseases, muscular dystrophy and other disorders,” Mark Currie, PhD, chief scientific officer and president of research and development at Ironwood, said in a press release. “Ironwood has developed significant pharmacologic expertise in guanylate cyclase pathways through our discovery of the GC-C agonist, linaclotide, and we have applied this GC expertise to discover multiple promising sGC stimulators.”

The Phase Ib clinical trial of IW-1973 comprises two phases: an open-label, single dose, crossover phase and a double-blind, randomized, placebo-controlled, with multiple ascending doses phase. The study intends to examine the tolerability, safety, pharmacodynamic outcomes and pharmacokinetic profile of IW-1973 in repeated doses given orally to healthy participants.

The Phase Ia clinical trial of IW-1701 is a double-blind, randomized, placebo-controlled, with a single ascending dose trial that will assess the tolerability, safety, pharmacodynamic outcomes and pharmacokinetic profile of IW-1701 given orally to healthy participants.

Results from the IW-1701 trial will be revealed in the first half of 2016, and from IW-1973 in the second half of the year.

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About the Author

Margarida Azevedo, MSc Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.