Trial Results
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.
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
The drug also showed rapid onset of response, including a lessening of skin pain5.
The overall safety profile was consistent with previous data, with no new safety signals observed511.
Investor Reaction
Despite meeting the primary endpoints, the results failed to excite investors6.
Incyte's stock price dropped around 10-15% following the announcement68.
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
The efficacy results were lower than those seen in Phase 2 trials and fell short of investor expectations82.
The placebo-adjusted response rates (10.5-13.7%) were lower compared to some competing biologic drugs for HS2.
There are concerns that the oral drug may struggle to compete with injectable biologic HS therapies, including newer IL-17 inhibitors19.
Future Outlook
Incyte plans to use these results to advance regulatory submissions worldwide11.
The drug is likely to be approved, but its commercial relevance beyond biologic-experienced patients remains to be determined8.
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