BOSTON, 31 de enero de 2018 /PRNewswire/ — AZTherapies, Inc. es una empresa farmacéutica de fase clínica avanzada, no cotizada en bolsa, situada en Boston, Massachusetts, que está desarrollando innovadores tratamientos para la enfermedad de Alzheimer, el accidente cerebrovascular isquémico y otras enfermedades neurológicas asociadas con neuroinflamación y neurodegeneración. El principal producto candidato, una combinación de tratamiento multifacético que usa dos fármacos rediseñados, cromolina e ibuprofeno, ALZT-OP1, se está estudiando en una prueba clínica de Fase 3 del Alzheimer en etapa inicial, la prueba COGNITE.
El doctor David Elmaleh, fundador, presidente de la junta directiva y director ejecutivo de AZTherapies, dijo: “AZTherapies usa estrictos criterios de inclusión, como biomarcadores del cerebro y medidas de cognición y función para incrementar la precisión del diagnóstico inicial de enfermedad de Alzheimer y la homogeneidad de los sujetos aleatorizados para la prueba COGNITE”.
La prueba COGNITE de Fase 3 en marcha de AZTherapies (n=600) ha examinado a más de 900 pacientes con más de 300 aleatorizados, 128 en la semana 48, y 56 en la semana 72, en la culminación del estudio. (https://cognitetrial.com)
“El aumento de la evidencia señala el importante papel que tiene la neuroinflamación en la declinación cognitiva en el Alzheimer y en otros trastornos neurodegenerativos”, dijo Karen Reeves, MD, presidenta y directora médica. “Los tratamientos innovadores para estas enfermedades devastadoras necesitan una estrategia de acción múltiple, incluida la modulación de las células microgliales, las células inmunológicas especializadas del cerebro, para mejorar la neuroprotección”.
Un artículo de investigación del laboratorio del doctor Rudolph Tanzi, profesor de Neurología Joseph. P. y Rose F. Kennedy, Escuela de Medicina de Harvard, vicepresidente de Neurología; director de la Unidad de Genética e Investigación del Envejecimiento, Hospital General de Massachusetts, publicado el 18 de enero de 2018 en Nature’s Scientific Reports, La cromolina reduce los niveles de la proteína amiloide β asociada con la enfermedad de Alzheimer promoviendo la fagocitosis microglial ( Zhang, Griuc, Hudry y otros; Scientific Reports (2018) 8:1144; DOI:10.1038/s41598-018-19641-2) apoya la razón científica de usar la combinación de fármacos de AZTherapies para retrasar o detener potencialmente la progresión de la enfermedad de Alzheimer en las primeras etapas de su manifestación. (https://www.nature.com/articles/s41598-018-19641-2)
El artículo de Scientific Reports evaluó los efectos de la cromolina y el ibuprofeno, usados en la prueba COGNITE, en un modelo de ratones Tg2576 de la enfermedad de Alzheimer para efectos de tratamiento inicial en la formación de placa y en análisis de célula microglial sobre sus efectos en activación de microglías como fármacos antiinflamatorios.
El artículo concluye: “Colectivamente nuestros datos revelan robustos efectos de la cromolina, sola o en combinación con el ibuprofeno, para reducir los niveles de Aβ propenso a la agregación e inducir un estado de activación microglial favoreciendo la fagocitosis Aβ versus un estado pro-neuroinflamatorio”.
AZTherapies (www.aztherapies.com) es una avanzada empresa de desarrollo de fármacos en fase clínica de Boston, Massachusetts. AZTherapies está usando enfoques innovadores en el descubrimiento, el desarrollo y la comercialización de novedosos tratamientos de la enfermedad de Alzheimer y el accidente cerebrovascular isquémico que podrían mejorar fundamentalmente el tratamiento de los pacientes, la calidad de vida y el control de la enfermedad. El programa principal de la empresa, ALZT-OP1, es una terapia de combinación compuesta por dos fármacos rediseñados con perfiles de seguridad bien conocidos con propiedad intelectual protegiendo la combinación, dosificación y formulación de los fármacos y las propiedades que suministrarán los fármacos a la sangre y al cerebro. La plataforma de la empresa también abarca ALZT-OP2, un tratamiento de fármacos para el mal de Alzheimer con el potencial de modificar la enfermedad en un estado avanzado de desarrollo preclínico; AZHALER-D, un nuevo inhalador desechable de una sola dosis en una fase avanzada de desarrollo, y ALZT-QoL, un tratamiento neurodegenerativo de fármacos creado para mejorar la calidad de vida de pacientes de la enfermedad de Alzheimer usando un M1 compensatorio (un agonista receptor muscarínico) con mecanismos ligando/receptor para mejorar la conectividad de la red cerebral. Los fármacos de AZTherapies se basan en tecnologías desarrolladas en el Hospital General de Massachusetts, un Hospital Docente de la Escuela de Medicina de Harvard.
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