Incyte’s oral HS drug hits study goals, but fails to excite investors
Trial Results
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Incyte reported positive topline results from two Phase 3 trials (STOP-HS1 and STOP-HS2) evaluating povorcitinib, an oral JAK1 inhibitor, in patients with moderate to severe hidradenitis suppurativa (HS)115.
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Both trials met their primary endpoint at the two tested doses (45 mg and 75 mg)11.
- The percentage of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12 was:
* - STOP-HS1:*
40.2% (45 mg) and 40.6% (75 mg) vs 29.7% for placebo
* - STOP-HS2:*
42.3% (both doses) vs 28.6% for placebo11
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The drug also showed rapid onset of response, including a lessening of skin pain5.
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The overall safety profile was consistent with previous data, with no new safety signals observed511.
Investor Reaction
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Despite meeting the primary endpoints, the results failed to excite investors6.
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Incyte's stock price dropped around 10-15% following the announcement68.
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The decline may reflect unfavorable comparisons between the Phase 3 data and both Incyte's midphase results and evidence on rival biologics2.
Reasons for Disappointment
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The efficacy results were lower than those seen in Phase 2 trials and fell short of investor expectations82.
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The placebo-adjusted response rates (10.5-13.7%) were lower compared to some competing biologic drugs for HS2.
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There are concerns that the oral drug may struggle to compete with injectable biologic HS therapies, including newer IL-17 inhibitors19.
Future Outlook
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Incyte plans to use these results to advance regulatory submissions worldwide11.
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The drug is likely to be approved, but its commercial relevance beyond biologic-experienced patients remains to be determined8.
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Potential usage may be mostly in patients who have already received a biologic or in biologic-naive patients who prefer an oral alternative8.
Sources:
2. https://www.fiercebiotech.com/biotech/incyte-posts-phase-3-skin-condition-wins-details-disappoint-sinking-stock
5. https://www.bioworld.com/articles/718331-street-less-than-jakd-about-incyte-phase-iii-data-in-hs
6. https://www.investopedia.com/incyte-leads-s-and-p-500-decliners-on-skin-condition-drug-trial-results-11698133
8. https://markets.businessinsider.com/news/stocks/leerink-says-incyte-s-povo-trial-results-disappoint-drug-likely-to-be-approved-1034485397
11. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-topline-results-two-phase-3-clinical