A First-in-Class Antibody Therapeutic for Treatment of Acromegaly
用于治疗肢端肥大症的一流抗体疗法
基本信息
- 批准号:10082375
- 负责人:
- 金额:$ 28.41万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-08-01 至 2022-07-31
- 项目状态:已结题
- 来源:
- 关键词:AcromegalyAddressAdultAffectAffinityAlloysAntibodiesAntibody TherapyBenignBindingBiological AssayCardiovascular DiseasesCause of DeathCell LineCellsCessation of lifeClinicalClinical TrialsCloningConsensusDataData AnalysesDiagnosisDiseaseDoseEndocrine System DiseasesEndocrine systemEpitopesGenetic EngineeringGoalsGrantGrowthGrowth Hormone ReceptorHeadHealthHormone secretionHormonesHumanHybridomasImpairmentIn VitroInsulin-Like Growth Factor ILeadLeftLibrariesLife ExpectancyMedicalMetabolic DiseasesMetabolic dysfunctionModelingMonoclonal AntibodiesNon-Insulin-Dependent Diabetes MellitusOperative Surgical ProceduresPatientsPhasePituitary GlandPituitary NeoplasmsPopulation GroupProductionPumpResearchRespiration DisordersRodent ModelSerumSomatotrophin increasedSomatotropinSpecificityTechnologyTestingTherapeuticTherapeutic antibodiesToxicity TestsTransgenic MiceTransgenic OrganismsTreatment EfficacyValidationbasecardiovascular risk factorcell bankcomorbiditydrug candidateeffective therapygrowth hormone deficiencyhuman monoclonal antibodiesimprovedin vitro activityin vivoin vivo Modelinnovationlead candidatelead optimizationlead serieslipid metabolismmanufacturabilitymortalityneonatal Fc receptorneutralizing antibodyneutralizing monoclonal antibodiesnovel therapeuticspatient populationpegvisomantpre-clinicalresearch clinical testingscreeningside effectskeletalsoft tissuesomatostatin analogtherapeutic candidatetumor
项目摘要
Project Summary: Acromegaly is an endocrine disorder caused by a benign pituitary tumor that affects
approximately 25,000 adults in the US. Left untreated, the average life expectancy is 10 years from diagnosis. It
is characterized by excess skeletal growth, soft-tissue enlargement, and permanent disfigurement, accompanied
by metabolic dysfunction resulting from excess growth hormone secreted by the tumor. The disease is associated
with 2- to 3-fold increased mortality and serious health complications and comorbidities. These include
cardiovascular disease, which is responsible for approximately 50% of acromegalic deaths, respiratory disorders,
which represent the second leading cause of death, and metabolic diseases such as type 2 diabetes and impaired
lipid metabolism that contribute to greater cardiovascular risk and mortality. The broad consensus is that
effective treatment is achieved by strict hormone control, demonstrated by the beneficial effects on comorbidities
and mortality. When surgery either fails to completely remove the tumor or is not an option, medical therapy is
required for long-term hormone control. However, control is achieved in only half of patients by the existing
therapies. There is a clear unmet medical need for a therapy that achieves long-term hormone control
consistently across the acromegaly patient population. Elixera’s goal is to develop a novel therapeutic as a first-
in-class treatment of acromegaly that fulfills this unmet medical need. The aim of the Phase 1 grant to identify
and characterize new product leads. The aim of the Phase 2 grant is to have a therapeutic candidate ready for
manufacture for an IND application with the FDA that will permit clinical trial testing in acromegaly patients in
the US.
肢端肥大症是一种由良性垂体瘤引起的内分泌紊乱,
在美国大约有25,000名成年人。如果不进行治疗,从诊断开始的平均预期寿命为10年。它
其特征是骨骼过度生长,软组织增大,永久性毁容,
由肿瘤分泌的过量生长激素引起的代谢功能障碍。这种疾病与
死亡率和严重的健康并发症和合并症增加2至3倍。这些包括
心血管疾病(导致约50%的肢端肥大症死亡)、呼吸系统疾病,
它代表了死亡的第二大原因,以及代谢性疾病,如2型糖尿病和受损
脂质代谢导致心血管风险和死亡率增加。广泛的共识是,
通过严格的激素控制实现有效治疗,对合并症的有益作用证明了这一点
and mortality.当手术不能完全切除肿瘤或不能选择时,
需要长期的激素控制。然而,通过现有的药物治疗,
治疗有一个明确的未满足的医疗需求的治疗,实现长期的激素控制
在肢端肥大症患者人群中一致。Elixera的目标是开发一种新的治疗方法作为第一个-
肢端肥大症的课堂治疗,满足了这一未满足的医疗需求。第一阶段赠款的目的是确定
并描述新产品线索。第二阶段补助金的目的是让一个治疗候选人准备好
FDA的IND申请将允许在肢端肥大症患者中进行临床试验测试,
美方
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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James Zanghi其他文献
James Zanghi的其他文献
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{{ truncateString('James Zanghi', 18)}}的其他基金
A First-in-Class Human Antibody Therapeutic for Treatment of Cushing's Disease
用于治疗库欣病的一流人类抗体疗法
- 批准号:
9909906 - 财政年份:2019
- 资助金额:
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