Ironwood, Allergan add a slate of PhIIIb data to its Linzess pitch for physicians, patients
With the dust settled on an R&D spinout, the fully commercial operations at Ironwood have come up with some late-stage data to up its Linzess marketing game.
Ironwood, along with partner Allergan, set out to collect evidence that their drug can improve the overall abdominal symptoms of irritable bowel syndrome with constipation (IBS-C), not just constipation. And the companies say that’s what they found in the Phase IIIb: Patients taking Linzess for 12 weeks saw a 29.7% mean decrease from baseline in a weekly score that measured bloating, pain and discomfort, compared to 18.3% for placebo (p<0.0001).
The trial also hit its secondary endpoints, including 40.5% of the drug arm meeting the criteria of a responder versus 23.4% in the placebo cohort (p<0.0001).
The new data are meant to bolster Ironwood sales reps as they communicate with doctors and patients, ideally growing a 7-year-old drug that brought in $785 million in 2018.
Cowen analyst Boris Peaker explained it this way:
Linzess’ current label notes reductions in “abdominal pain,” but not “bloating” or “discomfort,”, which management stated are the terms most frequently used by patients to describe their symptoms. The goal of the program was to enable the company to align its marketing with the language that physicians and patients use day-to-day in the clinic
Ironwood CMO Mike Shetzline added that the abdominal symptoms are typically identified by patients as the “most bothersome.”
While the data are “incrementally positive for Linzess,” though, Peaker sees no impact on his sales projections.
Linzess is one of two approved products Peter Hecht kept for Ironwood while spinning out the rest of the R&D work to a new company called Cyclerion — under investor pressure. The co-founder and longtime CEO then decamped for the new outfit and passed the reins to Mark Mallon, an AstraZeneca vet with significant international exposure.
Aside from a much less successful Trulance, Linzess also faces some degree of competition from Motegrity, a constipation drug Takeda now owns courtesy of its Shire buyout.
Generics for the drug could begin to emerge in 2030, Peaker added, at which point Ironwood’s currently experimental therapies — MD-7246 for IBS with diarrhea and IW-3718 for gastroesophageal reflux disease — are expected to fill the gap.
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