- Source: Press release
- "We are pleased both with the response rates and consistency of the results we are seeing in MANIFEST,"says Constellation Pharmaceuticals (NASDAQ:CNST) CEO Jigar Raythatha. "In addition, we are excited by results from our translational studies that suggest that CPI-0610 may potentially be a disease modifying therapy that affects all four hallmarks of myelofibrosis."
- The Phase 2 MANIFEST trial showed 42 of 63 evaluable patients (67%) achieved a ≥35% reduction in spleen volume (SVR35) at 24 weeks (the primary endpoint for Arm 3). 34 of 60 evaluable patients (57%) achieved a ≥50% reduction in Total Symptom Scores (TSS50) at 24 weeks. The median TSS reduction was 59%.
- CPI-0610 was generally well tolerated in MANIFEST, both as monotherapy and in combination with ruxolitinib, and in both JAK-inhibitor-naïve and -ineligible as well as JAK-inhibitor-experienced patients.
- Next up is MANIFEST-2, a global, double-blind, randomized Phase 3 clinical study with CPI-0610 in combination with ruxolitinib versus placebo plus ruxolitinib in JAK-inhibitor-naïve patients with primary myelofibrosis or post-ET or post-PV myelofibrosis who have splenomegaly and symptoms requiring therapy
- The news is also of interest for Incyte (NASDAQ:INCY) as CPI-0601 is combined with Incyte's Jakafi (ruxolitinib).
- A conference call is set for tomorrow morning at 8 AM.
- https://seekingalpha.com/news/3641962-eyes-on-constellation-pharma-after-ash-conference-presentation-on-cpiminus-0610-for
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