MEI Pharma (NASDAQ:MEIP) will report topline data from the Phase II trial (MEI-003) of pracinostat plus azacitidine in first-line myelodysplastic syndrome (MDS) in March 2015. I strongly believe the results will be positive.
Pracinostat (SB939) is a HDAC inhibitor discoved by S*Bio. MEI Pharma acquired the compound for $75.7 million in Augest 2012. The FDA has approved three HDAC inhibitors, known as Zolinza (vorinostat), Istodax (romidepsin) and Beleodaq (belinostat), for the treatment of PTCL. MEI Pharma is testing pracinostat in three Phase II trails: (1) first-line MDS (MEI-003); (2) AML (MEI-004); (3) 2nd-line MDS (MEI-005).
In the earlier pilot Phase II trial, pracinostat plus azacitidine showed an ORR of 89% (8/9) including 78% patients who achieved CR/CRi. Historical ORR for Vidaza (azacitidine) in MDS is only 16%. These data led to a new Phase II trial (MEI-003) evaluating pracinostat plus azacitidine vs. placebo plus azacitidine with a primary endpoint of CR.
I believe pracinostat plus azacitidine will demonstrate a huge improvement over azacitidine alone. Forthermore, interim analysis from the MEI-005 trial revealed an ORR of 3/28 in patients who have previously failed azacitidine or decitabine alone. This data in refractory MDS further proves pracinostat’s impressive clinical efficacy.
Approximately 13,000 patients in the U.S. are diagnosed with MDS each year. Cowen and Company analyst Nicholas Bishop expects pracinostat to generate sales of $500 million or more in MDS. According to TipRanks, the average price target for MEIP is $12.83.
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