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FORIMMEDIATERELEASE TreviTherapeuticsAnnouncesPositiveResultsfrom Phase2TrialinPrurigoNodularis OralNalbuphine®ERtrialachievedpositiveresultsofreduceditchintensityandother supportingefficacyendpointsinprurigonodularispatients New Haven, CT, October 13, 2016 – Trevi Therapeutics, Inc. (“Trevi” or the “Company”), a late-stage clinical development company developing oral Nalbuphine®ER for chronic pruritus conditions, today announced positive results from its Phase 2 trial for the treatment of moderate to severe prurigo nodularis. Prurigonodularis(PN),aseverelypruriticdermatologicalconditioncharacterizedby itchyskinpapulesandnodules,hassignificantimpactonqualityoflifeandhasno approved therapies. Trevi also previously reported statistically significant results from a robust Phase 2/3 trial with Nalbuphine ER in hemodialysis patients with uremicpruritus. Themulti-center,randomized,double-blind,placebo-controlled,parallel,three-arm studyevaluatedthesafetyandanti-pruriticefficacyofNalbuphineERtabletsdosed twice-daily at 90mg and 180mg in 62 patients in the United States and Europe. Patientswithmoderate-to-severeitchintensity,definedas≥5onthe0-10Numerical Rating Score (NRS) scale, were enrolled to evaluate drug efficacy across a representativepatientpopulationfortreatmentofthischronicindication.Theactual averagebaselineworstitchforenrolledpatientswas≥8,indicatingtheseverenature ofthedisease. The study consisted of a titration period of two weeks, followed by an eight-week blindedperiodonafixeddoseofdrugorplacebo,andatwo-weekwash-outperiod. Attheendofthewash-outperiod,patientswereeligibletorolloverintoaone-year openlabelextensionstudy.TheCompanyexpectstheopenlabelextensionstudyto becompletedinthethirdquarterof2017. Themainoutcomevariablesforthisstudywereresponderanalysesoftheproportion ofpatientswithatleasta30%or50%reductionintheir7-dayworst-itchintensity NRSfrombaselinetocompletionoftreatmentatweek10orlastobservationvisit. The proportion of patients in the Nalbuphine ER 180 mg BID arm meeting 50% responder criteria at week 10 or last observed visit (MITT population with n=18) approachedstatisticalsignificance(p=0.083),andthisarmmetstatisticalsignificance forpatients(n=12)completingtreatment(p=0.028).Themeanchangeinworstitch NRSwasadditionallyevaluated,andtheMITTpopulationoftheNalbuphineER180 mgBIDarmascomparedtoplaceboapproachedstatisticalsignificance(p=0.083)as well. This arm also met statistical significance for patients (n=12) completing treatment(p=0.025). TheItchyQoL™secondaryendpoint,22questionsthatmeasurehowpruritusaffects apatient’squalityoflife,providedsupportiveevidenceofafavorabletreatmenteffect on reduction in itch intensity compared to placebo. Change from baseline in the ItchyQoLtotalscorewassignificantlymorefavorablefortheNalbuphineER180mg BIDdosecomparedtoplacebo(p=0.022). The most common adverse events in the study were dizziness, nausea, headaches, andfatigue,themajorityofwhichweregrade1or2.Asseenpreviously,theincidence rate of these events was similar to placebo after the titration period. No serious adverseeventsattributedtothedrugwereobserved,andthestudyDSMBraisedno issuesthataffectedthecontinuationofthestudyorrequiredmodificationofstudy procedures. JenniferL.Good,Trevi’sPresidentandChiefExecutiveOfficer,said,“Wehavenow demonstrated that Nalbuphine ER can improve pruritus in two very different and severe itch conditions: prurigo nodularis and uremic pruritus. Itch is a significant unmet medical need resulting from many diseases in dermatology, oncology, hepatologyandneurology,andwebelieveNalbuphineERmayprovideanimportant therapyforthesepatients.” ThomasR.Sciascia,M.D.,Trevi’sChiefMedicalOfficer,said,“Prurigonodularisisa veryseriousdermatologiccondition,withnoapprovedtherapies.Onceapatientgets PN,theymaycopewiththediseaseformanyyears,withsignificantimpactontheir ongoingqualityoflife.Wearepleasedwiththeresultsofourtrial,andarepreparing foradiscussionwithbothFDAandEMAaboutthedevelopmentpathforwardwith thecriticalmassofdatawehavegathered.” TreviispreparingforanendofPhase2meetingforprurigonodularis,hasalready heldanendofPhase2meetingwithFDAforuremicpruritus,andwillinitiatePhase 3trialsinbothconditionsin2017. AboutTreviTherapeutics,Inc. TreviTherapeutics,Inc.isalate-stageclinicaldevelopmentcompanydevelopingoral Nalbuphine®ERforchronicpruritusconditions(itch).Pruritusdevelopsinvarious dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis.Uremicpruritusisapersistentanddebilitatingitchinpatientsondialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic skin nodules that are independentofunderlyingetiology.TherearenoapprovedtherapiesintheUnited StatesorEuropeforeithercondition. Nalbuphine ER is an oral extended release mu receptor antagonist and kappa receptoragonist.Bothmodalitieshavebeenshowntobeeffectiveinabolishingitch. Trevi believes that Nalbuphine ER’s unique dual mechanism of action, which has shownefficacyinaddressingpruritusinbothanimalstudiesandhumanclinicaltrials, mayhavebroadutilityintreatingchronicpruritus. Foundedin2011,TreviisheadquarteredinNewHaven,CT. Foradditionalinformation,visitwww.trevitherapeutics.com. ### Mediacontact: LauraBrophy (203)331-7618 [email protected]
