Accelerating Clinical Trials Evaluating Disease-Modifying Therapies For T1D

Overview

Accelerating Clinical Trials Evaluating Disease-Modifying Therapies For T1D

Letters of intent (LOI’s) are sought from academic and/or industry applicants for clinical trials to evaluate drugs and biologics to delay, halt, or reverse T1D through supporting or expanding endogenous beta cell survival and function, disrupting autoimmune pathobiology, or combinations of the above.

Breakthrough T1D is requesting applications that propose Proof of Concept (POC) human subject research trials to provide the data necessary to enable further clinical development, and Phase 1 or 2 trials to determine safety and efficacy. Trials should be powered for the stage of clinical development proposed and include the appropriate and justified endpoints. Phase 3 trials may be considered, however, approval must be obtained from the scientific contact below prior to submission of an LOI so that the budgetary and timeline needs of the trial can be assessed.

Eligibility

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