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Accelerating clinical trials evaluating disease-modifying therapies for T1D

Breakthrough T1D

Purpose Breakthrough T1D (formerly JDRF) is committed to accelerating the development of curative therapies from discovery research through clinical development and approval for type 1 diabetes (T1D). To this end, we invite applications that propose clinical trials to test small molecules, biologics, and combination therapies to delay, halt, or reverse the progression of T1D.

Background Despite recent advancements, there is no cure for T1D, an autoimmune disease characterized by the loss of pancreatic beta cell mass and function, resulting in insulin deficiency and dependency1. Following clinical diagnosis, exogenous insulin replacement therapy is the only established treatment, and people with T1D require insulin administration for life and constant glucose management. While increases in the use of continuous glucose monitors has led to improvement, over 70 percent of people living with T1D fail to achieve optimal glycemic outcomes, and face significant risk of long-term complications, mental burden of constant disease management, financial burden due to medical care, and loss of income and productivity2–4. New interventions to prevent, slow, or halt disease progression are urgently needed to improve outcomes for the increasing number of people diagnosed with T1D each year.

Recent advances in disease-modifying therapies (DMTs) for T1D include the approval of teplizumab (Tzield™) for individuals prior to clinical diagnosis (stage 2) in the USA. Several therapies have shown efficacy following diagnosis (stage 3) in phase I/II clinical trials, including teplizumab, abatacept, verapamil, rituximab, anti-thymocyte globulin (ATG), baricitinib, and golimumab5–11. These results highlight that interventions aimed at rebalancing the immune system to disrupt autoreactivity or to support endogenous beta cells have the potential to modify the course of disease and provide for the extension of beta cell function to delay or halt T1D progression. Unfortunately, there remains a significant deficit in the transition of these therapies from Phase 2 to Phase 3 trials and registrational approval. Therapeutic approaches focused on enhancing the regulatory elements of the immune system such as broad Treg transfer therapy and low dose IL-2 have shown mixed efficacy in human trials12–15. Novel approaches and strategies to induce tolerance in the clinical setting are of high priority for establishing therapies that promote sustained protection of beta cells. Finally, approaches to regenerate beta cells to increase functional beta cell mass have shown promise in pre-clinical studies, however, the clinical translation of these has been delayed due to the need for targeted delivery of these reagents to overcome safety concerns.

To achieve the Breakthrough T1D Cures Program goal of advancing disease-modifying therapies that delay, halt, or reverse the progression of T1D, multiple shots-on-goal are needed to build a robust clinical pipeline and accelerate development. The continued identification of novel therapies that exhibit clinical efficacy, or the assessment of therapies that have shown efficacy in other autoimmune diseases in T1D, is a key component of successfully building that pipeline. In addition, T1D is a complex disease, suggesting that success may require intervention towards multiple targets or pathways, or the development of therapies that address both immune rebalancing and beta cell support or expansion. Therefore, the clinical assessment of combinations of assets that have shown efficacy or have the potential to increase efficacy is of high priority. To these ends, Breakthrough T1D is soliciting proposals aimed at the clinical assessment of novel or untested disease-modifying therapies, or combinations of molecules that have shown preliminary clinical efficacy as single agents, with the potential to delay, halt, or reverse the progression of disease in individuals in Stage 3 of disease. Expanding the repertoire of therapeutic approaches showing efficacy following diagnosis will increase the probability of success in meeting an unmet need for patients, provide critical data for the establishment of endpoints to increase trial efficiencies, and develop a path for testing these therapies in populations earlier in disease (or in those with established T1D in combination with beta cell replacement therapy).

Funding Opportunity Objectives 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.

Examples of research proposals appropriate for this RFA include, but are not limited to:

• Trials evaluating novel small molecule drugs or biologics in people with T1D. • Clinical trials evaluating the repurposing of small molecule drugs or biologics with demonstrated efficacy in non-T1D populations that have clear rationale or preclinical data for assessment in T1D.

• Inclusion of people with T1D in existing or planned clinical trials evaluating small molecule drugs or biologics in a non-T1D population.

• The inclusion of an additional arm to an ongoing T1D trial to test an additional intervention or new patient population.

• T1D-focused real world studies collecting efficacy and safety data on drugs or biologics with expected benefits for people with T1D.

Examples of research that will not be considered for this RFA include: • Non-clinical and preclinical studies.

• Observational research on T1D-specific pathophysiology or epidemiology. • Clinical trials that do not include people with T1D (however, trials may include other populations in addition to people with T1D).

• Clinical trials assessing therapies in populations other than Stage 3 (unless approved in advance of submission).

• Clinical trials assessing combinations of more than 2 interventions, unless approved by the scientific contact below prior to submission of the LOI.

• Clinical trials assessing nutraceuticals such as Vitamin D as a monotherapy.

• Clinical trials evaluating lifestyle interventions such as diet and exercise.

Letter of Intent Prospective applicants should submit a LOI online through via RMS360 (instructions below) to be considered for a full proposal request. The LOI template provided on the RMS360 website must be used to complete the applications. Applicants will be notified according to the timeline below if they have been approved to submit a full proposal application.

Letters of intent should use the template provided and must include the following information:

• Background/Rationale, preliminary data and references to relevant publications, specific aims, project deliverables, and collaborative framework (if applicable).

• Justification for choice of trial endpoint(s).

• Targeted participant population, recruitment strategy, and inclusion/exclusion criteria.

• Plan for acquiring drugs and placebo/controls used in the study.

• Intellectual property or commercial efforts associated with the current application, including a list of current business partnerships relevant to the proposed work.

Administrative Submission Instructions

Applicants should register and submit their completed LOI (and full proposal, if requested) in RMS360. An informational webinar will be held on Wednesday August 28, 2024 at 2:00pm to provide further information on this opportunity. Please pre-register here.

Deadlines (no extensions will be given)

• LOI deadline: Thursday October 10, 2024

• Notification of LOI Outcome: Thursday October 31, 2024

• Full proposal deadline: Monday January 13, 2025

• Response to applicants: June 2025

• Earliest anticipated start date: August 2025

Specialties

Clinical Trials

Others

Immunology

Eligibility Requirements

Applications may be submitted by domestic and foreign non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Applicants must hold an M.D., D.M.D, D.V.M., Ph.D., or equivalent and have a faculty position or equivalent at a college, university, medical school, or other research facility. Please note that applications from for-profit entities or industry collaborations with academia may be submitted to this RFA; however, additional information will be requested from for-profit entities if a full application is invited. There are no citizenship requirements for this program. To assure continued excellence and diversity among applicants and awardees, Breakthrough T1D welcomes applications from all qualified individuals and encourages applications from persons with disabilities, women, and members of minority groups underrepresented in the sciences.

Sponsor Details

Sponsor Institute/Organizations: Breakthrough T1D

Address: 200 Vesey Street, 28th Floor New York, NY 10281

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