The JAK inhibitor competition, and why Imetelstat out-classes them all

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Fishermangents
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The JAK inhibitor competition, and why Imetelstat out-classes them all

Post by Fishermangents » Fri Feb 12, 2016 10:51 am

repost from sdrawkcabeman (YMB)

Everyone's familiar w/Rux's profile which, broadly, is very modest efficacy w/myelosuppression, abnormal LFTs, and up to 89% discontinuation w/in 3 yrs.

SNY's Fedratinib was scrapped b/c pts developed Wernicke's encephalopathy. The whole program was written off, this really demonstrates the risk of new drug development.

CTIC's Pacritinib is on partial hold after increased adverse events in the experimental arm, NDA was withdrawn, now they require more dosing studies.

And the dark horse is GILD's Momelotinib, a drug that's taken a rather circuitous developmental path. It's going head to head against Rux, consequently the experimental arm requires Rux virgins, which significantly slowed a large enrollment target of 420 pts. Mome doesn't cause the anemia that Rux does, a huge benefit over Rux, but the at the cost of neuropathy for some pts, which didn't attenuate after discontinuation.

These 4 competitors starkly demonstrate why Imet's approval is an eventuality. Although Imet's myelosuppression must be managed(and quite simply so, by does modulation), Imet has never shown a detrimental effect like Fedratinib; nor any permanent effects like Mome's neuropathy; and Imet's experimental arms for multiple trials have shown disease modifying activity, as opposed to either of Pacritinib's increased adverse events or Rux's very underwhelming symptom management. To top it all off, Imet produces CRs in ET/MF, which is unprecedented, more so b/c it was achieved as a single agent. For a first-in-class drug, this type of activity is an overwhelmingly clear indication of its value.

And now consider the speed Imet's trials are moving at, w/easy enrollment numbers, especially since IMbark is for pts R/R to JAK inhibitors, and easy primary outcome targets. And the trial design is geared for expedited approval, primary analysis at MAR'17 is 1 yr away. Imet has better efficacy than the other drugs, w/out the complications, and w/out the development risks. Imet out-classes them all.

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