The Ann Theodore Foundation (ATF) is launching a new funding program to support the study of repurposed mechanistic target of rapamycin (mTOR) inhibitors as treatments for cutaneous sarcoidosis. This program will be executed in partnership with the Milken Institute Science Philanthropy Accelerator for Research and Collaboration (SPARC).

Program Description

The ATF Sarcoidosis Inhibitor of mTOR (SIM) Trial is now accepting applications for two-year investigator-initiated clinical studies that will test the efficacy of mTOR inhibitors in treating cutaneous sarcoidosis. This study would be considered an early Phase 2 study and would provide scientific support for a future Phase 2b/3 or a Phase 3 study. The ATF will fund this study, and SPARC will operate as program administrators.

The ATF SIM Trial intends to award one two-year investigator-initiated clinical trial grant led by established, independent investigators at qualifying research-based institutions around the world. 

The awarded team will be eligible for up to $250,000 USD in funding for direct costs per year, plus 15% in indirect costs, totaling $287,000 USD per year for a total of $575,000 over two years. Applications that define the study population to appropriately power the trial and demonstrate a history or capacity to fully enroll during the grant period, including clinical trial networks and consortia, will be prioritized.

Background

Sarcoidosis is a disease hallmarked by clusters of immune cells, known as granulomas, forming in various organs throughout the body. Sarcoidosis is often observed in the lungs, but many other organs can be impacted. In some cases, the granulomas resolve spontaneously, but for others, the condition can become chronic and debilitating. Skin is the second most affected organ in sarcoidosis. Cutaneous sarcoidosis symptoms include painful rashes, skin lesions, and subcutaneous growths that often form around scars and tattoos.

While sarcoidosis is often considered a rare disease, its true prevalence may be higher due to underdiagnosis and a lack of awareness among clinicians. As of this program’s launch, the only Food and Drug Administration (FDA) approved pharmacological agents for sarcoidosis treatment are prednisone and repository corticotropin injection. Treatment options for individuals with sarcoidosis are limited. Regulatory approval for other drugs would mean that insurers would be more likely to cover patient costs for these treatments and would pave the way for new regulatory approvals.

Potential for mTOR Inhibitor Sarcoidosis Treatment

The FDA has approved mTOR inhibitors for the treatment of atherosclerosis, renal and breast cancers, tuberous sclerosis complex, lymphangioleiomyomatosis, and other conditions. A recent study testing the safety and efficacy of sirolimus in treating cutaneous sarcoidosis found that systemic treatment alleviated symptoms in 7 of 10 participants. This effect persisted for over a year after treatment concluded for all seven responders (https://pubmed.ncbi.nlm.nih.gov/38267106/). Additionally, a recent review paper indicates that many patients who received sirolimus experienced significant improvement; however, it also notes that no randomized controlled trials have been conducted (https://pubmed.ncbi.nlm.nih.gov/40996589/). ATF seeks to replicate these findings at an appropriate scale to support movement toward regulatory approval for a sarcoidosis treatment.

Scientific Focus

All submitted applications must propose to test the efficacy of an mTOR inhibitor in treating individuals diagnosed with cutaneous sarcoidosis. Recruited participants may have additional sarcoidosis subtype diagnoses. Submitted proposals should outline a trial designed to generate essential data on mTOR inhibitor efficacy and safety in people with cutaneous sarcoidosis (with or without other organ involvement). Trial results should allow for the determination of whether the specific intervention merits further development towards the ultimate goal of regulatory approval. To be eligible for funding, the proposed study must:

• Study the interventional effects of an existing pharmacological mTOR inhibitor, with priority given to previously studied mTOR inhibitors,
• Recruit a representative population of individuals diagnosed with cutaneous sarcoidosis, with or without other organ involvement, and
• Be at a mid-stage, ideally Phase 2a or 2b, of exploring safety or efficacy with the goal of providing justification for a larger Phase 2b or Phase 3 study
• Include primary endpoints focused on the impact of mTOR inhibitors on cutaneous sarcoidosis

Examples of research topics that will not be considered for the RFP include:

• Preclinical and non-clinical studies
• Observational research on sarcoidosis-specific pathophysiology or epidemiology
• Clinical trials that do not primarily include people diagnosed with cutaneous sarcoidosis
• Clinical trials assessing combinations of interventions. However, participants are permitted to have a history of taking other sarcoidosis therapeutics, except mTOR inhibitors
  • Clinical trials evaluating lifestyle interventions such as diet and exercise

For more information, including eligibility criteria, please refer to the Request for Proposals (RFP).

Review

The Scientific Advisory Board will review each application. All applications will be reviewed based on:

• Their scientific and technical merit; 
• Team capabilities and competencies; 
• Path to regulatory approval plan;
• and cost realism. 

Dates and Timeline

• Thursday, February 26, 2026: Informational session on SIM will be held over Zoom at 3 p.m. Eastern Time. Use the following link to register: https://milkeninstitute-org.zoom.us/meeting/register/x2EHV718SOWhJz-fwQeJig.
• Monday, April 20, 2026: Applicants must submit their full proposals via the Survey Monkey Apply grant portal by 11:59 p.m. Eastern Time.
• June 2026: Awardees who are selected for funding are notified.
• August 2026: Projects begin.
• Summer 2026: The Funded Investigators Meeting occurs. Lead PIs of all teams funded by ATF sarcoidosis grant programs are expected to attend.

Grant Terms

Each funded research institution and the lead investigator will be required to co-sign and agree in writing to SIM’s grant terms within thirty (30) days from receipt of notice of the award and prior to funds being released. SIM’s grant terms include the following:

1. Signature confirming that the information provided in the grant proposal is true, complete, and accurate. False or fraudulent statements may subject the funded organization to criminal, civil, or administrative penalties.
2. SIM will require a copy of the full protocol before initial payments. 
3. Any substantial changes to the project, including activities, new clinical sites, budget, protocols, or grant period, require written approval from SIM before proceeding with such activities, spending, or committing any remaining funds from the grant.
   1. Any funds not expended or committed for the purposes of the grant must be returned to SIM unless otherwise agreed by the Foundation in writing.
   2. If an applicant organization proposes to supplement any funds provided by SIM with funds provided by a third party, the organization must first provide notice to SIM and must ensure that the funding terms that attach to any such third-party funds do not preclude sharing of data or publication of project results as contemplated in this RFP. 
4. The applicant organization must be able to receive awarded funds and allocate them toward the funded sarcoidosis research project.
   1. For-profit organizations must retain funding received from SIM in an account specifically for these funds and provide SIM with accurate expenditure reporting every 6 months.
5. The funded investigators must submit a lay, non-confidential scientific abstract intended for a public audience for SIM to display on their website.
6. The lead PIs are expected to attend and participate in annual investigators’ meetings to present and discuss their research plan and preliminary results in the research supported by the collaborative grant. The annual investigators' meeting is planned for August 2026. 
7. The funded investigators are expected to attend and participate in Quarterly Check-In Meetings. These virtual meetings will bring together currently funded investigators to provide opportunities to share updates and solicit feedback from their peers. These meetings may also be used as workshops to support the investigators or the sarcoidosis ecosystem.
8. Funded organizations must agree to the following reporting requirements:
   1. Submission of full written narrative and financial reports at the conclusion of the granting period, at twenty-four (24) months, following the award payment.
   2. At twelve (12) months after receiving funding, applicants shall also share brief updates describing major project highlights and/or progress based on pre-determined milestones after the initial award payment as well as participate in a brief virtual meeting with other grant recipients to discuss plans, progress, and findings. 
9. Full IRB and EC or the local equivalent approval will be required before initial payments are made. Conditional IRB/EC approvals will not be sufficient for initial payments.
10. It is a condition of any funding provided by SIM that the investigator seeks to have the results of the funded project be made available in the format most appropriate for the study results. If study results can be published in a peer-reviewed journal, they must be submitted to an open-access journal or a pre-print journal within eighteen (18) months after the completion of the project. Each publication would acknowledge the SIM’s role in supporting the project in a form approved by SIM. If the investigator does not publish the results within such a timeframe, SIM would have the right to make such results public. Investigators may specifically budget for such publications. If the results are not appropriate to submit to a peer-reviewed journal, the study results must be submitted to a preprint journal within eighteen (18) months after completion of the project. Funded investigators must make SIM aware of any publication supported by SIM funds within thirty (30) days of publication. 
11. A lay summary of the project goals and findings must be sent to all recruited participants within three (3) months of project completion.

Data and Intellectual Property

The funded organization would own the rights in all intellectual property developed by or on behalf of that organization under SIM funding, in accordance with such organization’s applicable intellectual property policies. SIM would have the right to use and to practice all such intellectual property for internal, non-commercial research purposes, and would also have the right to publicly disclose research results in press releases, announcements, and otherwise (subject to the funded organization’s advance approval if any such public disclosure will occur prior to publication of the applicable results). Intellectual property will be sublicensable to nonprofit research institutions for non-commercial educational and research purposes only and will only be used in research related to the prevention, diagnosis, treatment, or cure of sarcoidosis and conditions or complications caused by sarcoidosis. 

Each funded organization must agree to share project results, data (de-identified where applicable), reagents, and other research tools developed under SIM funding with other ATF-funded investigators for non-commercial use to advance the understanding of sarcoidosis and to maximize scientific impact. 

Funding Awarded in SIM's Discretion

Responding to this RFP or submitting a full proposal does not entitle any individual or institution to receive funding from SIM. Funding, if any, would be provided in SIM’s sole discretion pursuant to the terms of a written grant agreement executed by SIM and the selected awardee institution and acknowledged by the PI.  

Contact Information

For all inquiries about the online process, necessary documentation, research priorities, or scientific requirements, please contact sarcoidosisgrant@milkeninstitute.org. 

An automated email confirmation is generated upon submission of the application. If you do not receive a confirmation within 24 hours of submitting your application, please check your spam filters and then contact: sarcoidosisgrant@milkeninstitute.org.