- Yesterday Trevi Therapeutics Inc's TRVI Phase 2b/3 trial (PRISM) evaluating Haduvio (nalbuphine ER) for prurigo nodularis (PN) successfully met the key primary and secondary endpoints.
- Needham writes that Haduvio had a quick onset of action, reaching stat sig at 6 weeks with efficacy that had yet to plateau at the wk-14 readout.
- Trevi will meet with FDA before initiating a Phase 3 trial that is likely to start in 1H23
- The analysts say that the second program de-risking trial readout for Haduvio in 1H22 and believe Trevi's valuation discounts Haduvio's potential in both IPF cough and PN.
- Needham maintains its Buy rating and adjusts the price target to $10 from $8 to reflect additional de-risking of the PN program.
- Next Steps. Patients that completed the PRISM trial were eligible to enroll in an OLE trial to receive an additional 38-wks of Haduvio treatment. Needham says these data will provide a better picture of Haduvio's long-term efficacy and tolerability.
- Price Action: TRVI shares are up 7.33% at $2.63 during the market session on the last check Thursday.
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