Cyclerion axes another program as struggles grow for Peter Hecht's Ironwood spinout
Things have not been going well in the old Ironwood pipeline.
Last month, the Boston-based pharmaceutical company announced that the second of just two experimental drugs they had left in the pipeline failed a Phase III trial, triggering significant layoffs. And today, their Peter Hecht-led R&D-focused spinoff, Cyclerion, announced that it had also failed their second major study in a year, forcing them to abandon the program.
Cyclerion said today that a Phase II study for a drug meant to ameliorate symptoms in patients with sickle cell disease “did not demonstrate adequate activity to support further clinical development.” The company did not release any data but said they would publish the results in a future forum. They indicated, as they did with their previous trial miss, that they saw potential for the compound, though they would not bring it forward.
“While we are disappointed that we won’t be contributing a much-needed new treatment option for SCD, we are continuing to analyze the data to understand several potential biomarker signals, including inflammation, as we explore partnership options for this program,” Hecht said in a statement.
The sickle cell program will be the second to bite the dust in Cyclerion’s two-year history. Last October, a drug known as praliciguat that the biotech pushed into mid-stage trials failed back-to-back studies on heart failure and diabetic neuropathy, cleaving a 68% chunk out of the stock price and forcing 30 layoffs.
The company’s stock fell another 44% Monday morning, from $7.12 to $3.97.
The repeated stumbles have dealt a substantial blow to both Cyclerion and Ironwood since the two parted ways in the wake of an activist attack from investor Alex Denner. Ironwood was meant to focus on commercialization of an approved drug and two compounds in Phase III. Cyclerion, initially labeled simply “R&D Co.,” was meant to develop their early-stage line of cyclic guanosine monophosphates.
Now, the two monophosphates that are furthest along have failed and Ironwood has no drugs in its pipeline. Cyclerion is worth about a third of its value when it launched, though Ironwood has maintained its market cap on the back of its commercial drug Linzess.
Hecht’s focus will now pivot to central nervous system disorders. The company announced today results from a Phase I pharmacology study for a monophosphate that can cross the blood-brain barrier. They have plans to start trials in two different disorders: mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (a single condition often short-handed as MELAS) and Alzheimer’s disease with vascular pathology.
