Phase II failure sees stock plunge and job cutbacks for Infinity Pharmaceuticals
Shares at Infinity Pharmaceuticals (NASDAQ: INFI) fell around 70% upon the announcement of new Phase II data for their non-Hodgkin lymphoma monotherapy, duvelisib.
The investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma was being developed by Infinity, in partnership with AbbVie. The Phase II DYNAMO trial met its primary endpoint of overall response rate, with 46%, but all of these were partial responses.
The disappointing nature of these responses has led AbbVie to suspend plans for its sponsored Phase Ib/II trial evaluating duvelisib in combination with Venclexta (venetoclax), a chronic lymphocytic leukaemia drug that was approved early this year.
This AbbVie move signalled a strategic restructuring at Infinity’s discovery research organisation, which will see 46 jobs, or 21% of its workforce, lost.
President and CEO at Infinity, Adelene Perkins, says: “While the DYNAMO study met its primary endpoint, we hoped that treatment with duvelisib as a monotherapy would have provided a larger clinical benefit for patients with advanced indolent non-Hodgkin lymphoma, a difficult-to-treat disease. We plan to seek feedback from the US Food and Drug Administration to determine our next steps with respect to duvelisib.
“This restructuring is a necessary step to preserve financial resources as we explore options for duvelisib and the advancement of IPI-549, our second clinical program. These were very difficult decisions that were undertaken, and I would like to personally express my deep appreciation to the very talented and dedicated Citizen-Owners impacted by the restructuring for their tremendous contributions to Infinity.”
The company also indicates that their existing financial guidance for 2016 should no longer be relied upon. They intend to provide updated guidance following the resolution on these restructuring activities.
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