BMF-219isanovelcovalentmenininhibitordesignedtoregenerateinsulin-producingbetacellswiththeaimtocuretype1diabetes
TheobjectiveofCOVALENT-112istoevaluatethesafety,efficacy,anddurabilityofBMF-219,acovalentmenininhibitor,inpotentiallyrestoringbetacellfunction.Betacelllossisarootcauseoftype1andtype2diabetes.Menininhibitionhasbeendemonstratedtoimprovebetacellfunction.PreclinicalstudieshaveshownthepotentialofBMF-219tospecificallyregenerateandretaininsulin-producingbetacellsinanimalmodelsoftype1andtype2diabetes.
"WeareexcitedtoevaluatethepotentialimpactBMF-219mayhaveinpeoplewithtype1diabetes.Currently,theonlyavailabletherapyforthesepatientsisexogenousinsulinwhichrequiresintensivemanagementwithchronicmultipledailyinsulininjectionsortreatmentwithaninsulinpump,andhasariskofhypoglycemia,increasedmorbidityandmortality,"statedJuanPabloFrias,MD,BiomeaFusion'sChiefMedicalOfficer.Headded,"Bytargetingoneoftherootcausesofdiabetes,wemaysuccessfullyrestorethehealthandfunctionofthebody'sownmechanismtoproduceinsulin,thebetacells.I'mexcitedforpatientsasBMF-219hasshownasignificantabilitytoregenerateandretainthosecriticalcellsinpreclinicalandearly-phaseclinicalstudiesintype2diabetes."
"OurinitialclinicaldatahasdemonstratedthatBMF-219ispotentiallydiseasemodifyingforpeoplewithtype2diabetes.Wehavebeendiligenttobuildaprogramthatwillevaluatemostpeoplewithdiabetes,includingthosewithtype1diabetes.LastweekweannouncedtheexpansionofourexistingPhaseI/IIstudyenrollingapproximately300additionalpatientswithtype2diabetes.Today,wearethrilledtoannouncethattheFDAhasalsoclearedourINDtostudyBMF-219intype1diabetes.Ournewstudy,COVALENT112,isdesignedtoenroll150patientswithtype1diabetes,"statedThomasButler,BiomeaFusion'sChiefExecutiveOfficerandChairmanoftheBoard.Hefurtheradded,"IamimmenselyproudthatTeamFusionhasachievedtheseclinicalandregulatorymilestonesmorethan3monthsaheadofourguidedtimelines.WehavenowestablishedaclinicaldevelopmentplanthatwebelievewillfullyexplorethepotentialofBMF-219acrossthespectrumofdiabetes.Thenextquarterswillbeveryexcitingasweexpectthesestudieswillbegintoreadout."
AboutCOVALENT-112
COVALENT-112isamulti-site,randomized,double-blind,placebo-controlledPhaseIIstudyinadultswithstage3type1diabetes.Thisstagedescribestheperiodfollowingclinicaldiagnosisoftype1diabeteswhensymptomsarepresentduetosignificantbetacellloss.COVALENT-112willbeamulti-armtrialcomparingtwodifferentdosesofBMF-219toplacebocontrol(1:1:1)toevaluatethesafety,tolerability,andefficacyofBMF-219inpersonswithtype1diabetes.Approximately150patientswillbeenrolledinthetrialandwillreceiveeitherBMF-219orplacebofor12weeks,followedbya40week"off-treatment"period.
AboutBiomeaFusion
BiomeaFusionisaclinicalstagebiopharmaceuticalcompanyfocusedonthediscoveryanddevelopmentofcovalentsmallmoleculestotreatpatientswithgeneticallydefinedcancersandmetabolicdiseases.Acovalentsmallmoleculeisasyntheticcompoundthatformsapermanentbondtoitstargetproteinandoffersanumberofpotentialadvantagesoverconventionalnon-covalentdrugs,includinggreatertargetselectivity,lowerdrugexposure,andtheabilitytodriveadeeper,moredurableresponse.
WeareutilizingourproprietaryFUSIONSystemtodiscover,designanddevelopapipelineofnext-generationcovalent-bindingsmallmoleculemedicinesdesignedtomaximizeclinicalbenefitforpatientswithvariouscancersandmetabolicdiseases,includingdiabetes.Weaimtohaveanoutsizedimpactonthetreatmentofdiseaseforthepatientsweserve.Weaimtocure.
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CONTACT:Contact:InvestorRelationsChunyiZhao,PhDSr.ManagerofInvestorRelations&CorporateDevelopmentczhao@biomeafusion.comMediaRelationsNeeraChaudharynchaudhary@biomeafusion.comBMF-219是一种新型共价脑膜素抑制剂，旨在再生产生胰岛素的β细胞，旨在治愈1型糖尿病
COVALENT-112的目标是评估共价脑膜抑制剂BMF-219在可能恢复β细胞功能方面的安全性、有效性和耐久性。β细胞流失是1型和2型糖尿病的根本原因。脑膜抑制已被证明可以改善β细胞的功能。临床前研究表明，BMF-219有可能在1型和2型糖尿病的动物模型中特异性再生和保留产生胰岛素的β细胞。
“我们很高兴能够评估BMF-219可能对1型糖尿病患者产生的潜在影响。目前，这些患者唯一可用的治疗方法是外源性胰岛素，它需要通过每天多次注射胰岛素或使用胰岛素泵进行强化管理，并且存在低血糖、发病率和死亡率增加的风险。”BiomeaFusion首席医学官胡安·巴勃罗·弗里亚斯医学博士说。他补充说：“通过靶向糖尿病的根本原因之一，我们可以成功地恢复人体自身产生胰岛素的机制，即β细胞的健康和功能。我为患者感到兴奋，因为BMF-219在2型糖尿病的临床前和早期临床研究中显示出再生和保留这些关键细胞的显著能力。”
关于COVALENT-112
COVALENT-112是一项针对成人3期1型糖尿病患者的多点、随机、双盲、安慰剂对照的II期研究。该阶段描述了临床诊断为1型糖尿病之后的时期，此时由于大量的β细胞流失而出现症状。COVALENT-112将是一项多组试验，将两种不同剂量的BMF-219与安慰剂对照组（1:1:1）进行比较，以评估BMF-219在1型糖尿病患者中的安全性、耐受性和有效性。该试验将招收大约150名患者，他们将接受BMF-219或安慰剂，持续12周，然后是40周的“停止治疗”期。
关于BiomeaFusion
BiomeaFusion是一家临床阶段的生物制药公司，专注于发现和开发共价小分子，用于治疗基因定义的癌症和代谢性疾病患者。共价小分子是一种与其靶蛋白形成永久结合的合成化合物，与传统的非共价药物相比，它具有许多潜在的优势，包括更高的靶点选择性、更低的药物暴露以及能够推动更深、更持久的反应。
我们正在利用我们专有的FUSION系统来发现、设计和开发下一代共价结合小分子药物产品线，旨在最大限度地提高包括糖尿病在内的各种癌症和代谢性疾病患者的临床益处。我们的目标是对我们所服务的患者的疾病治疗产生巨大影响。我们的目标是治愈。
联系人：联系人：投资者关系赵春义，博士投资者关系与企业发展高级经理czhao@biomeafusion.com媒体关系NeeraChaudharynchaudhary@biomeafusion.com