Solve M.E. is proud to announce that we’ve selected the Simmaron Research Institute as the winner of our second Solve ME/CFS Catalyst Award for its study, “Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions.” The study hypothesizes that mTOR inhibition through rapamycin may address observed findings of autophagy impairment and symptoms in a subset of patients with ME/CFS and other infection-associated chronic conditions and illnesses (IACCIs).
Simmaron is a non-profit research center dedicated to developing treatments for ME/CFS and Long Covid. Leading this project will be Dr. C. Gunnar Gottschalk (Simmaron, chief executive officer), Dr. David Kaufman (Center for Complex Diseases, founder), and Dr. Avik Roy (Simmaron, chief scientific officer).
In 2022, Solve awarded Dr. Roy a Ramsay Research Grant to study how symptoms of ME/CFS relate to problems with autophagy. Autophagy is the cellular process of clearing unwanted debris (like unnecessary proteins or damaged mitochondria). With Dr. Roy’s Ramsay Research Grant funds, follow-up funds from the NIH, and substantial investment by Simmaron’s private donors, the Simmaron team showed that a subset of people with ME/CFS have problems with muscle-cell autophagy and that these problems increase post-exertional malaise.
They established animal models for studying autophagy and post-exertional malaise in the context of ME/CFS and started a multicenter clinical trial to test whether they could repurpose the drug rapamycin for reducing post-exertional malaise and cognitive dysfunction in the subset of people with autophagy-related symptoms. (Rapamycin is an FDA-approved drug that reverses problems with autophagy.) A key strength of the study is tracking autophagy biomarkers to determine if these markers will help predict patients most likely to respond to this treatment and develop a test to that end.
Early results from almost 80 participants are highly encouraging—rapamycin treatment is significantly lowering fatigue, post-exertional malaise (PEM), orthostatic intolerance, and sleep issues for selected participants. Now, Solve is awarding the research team more funds to enroll more participants and to collect more samples from more time points.
Read a preprint from Phase 1 of the trial here.
Solve CEO Emily Taylor noted, “We’re excited to fund this innovative study exploring rapamycin as a potential treatment for ME/CFS and related conditions. By focusing on autophagy and using real-world biomarkers, this research brings science closer to solutions—at no cost to patients and with powerful collaborations behind it. It’s a meaningful step toward care people urgently need.”
Why This Study Matters to the Patient Community:
- Advances an FDA-approved drug for reducing key symptoms of ME/CFS and Long Covid: Supports repurposing rapamycin to reduce fatigue, orthostatic intolerance, post-exertional malaise, and sleep issues for a subset of people with ME/CFS.
- Tracks powerful biomarkers with a goal of identifying which people are likely to respond to treatment: Blood-based biomarkers of autophagy could help predict which people will benefit from this treatment.
- Produces experimental reagents valuable for studying how autophagy drives symptoms of infection-associated chronic conditions: Collaborations with major biotech companies (ThermoFisher) will produce high-quality and clinically validated antibodies and assays to measure autophagy biomarkers.
- Focused on helping patients: Solve-awarded funds will be used to give patients a uniform formulation of rapamycin at no cost.
- Fosters powerful research collaborations to help people with ME/CFS: Collaborators include those at the University of Wisconsin Milwaukee, the Milwaukee Institute for Drug Discovery, Cornell University, Center for Complex Diseases, Mayo Clinic, Bateman Horne Center, and AgelessRx.
Simmaron CEO Dr. C. Gunnar Gottschalk noted: “Our goal is to develop a predictive test to identify which patients are more likely to benefit from rapamycin, and this funding from Solve will help us expand enrollment to get us there faster.”
Solve will host Dr. Gottschalk, Dr. Roy, and Dr. Stephanie Grach (Assistant Professor of Medicine and Consultant in General Internal Medicine at Mayo Clinic-Rochester) for a free webinar about the Catalyst Award-winning rapamycin study on Thursday, September 4th at 3 pm PT /6 pm ET. Register here.
Solve has a long history of funding innovative research projects in pursuit of treatments and cures for ME/CFS and associated conditions. Through its Ramsay Research Grant Program, Solve M.E. has supported nearly 100 early-career investigators with seed funding—yielding a 34x return on investment in follow-on grants and external funding. Now, with its Catalyst Award program, Solve is helping existing studies reach completion faster.
On World ME Day (May 12), Solve announced Dr. Akiko Iwasaki (Yale School of Medicine) as the winner of its first Catalyst Award for her study “Probing Functional Autoantibodies in Patients with ME/CFS,” a vital step to uncover the biological drivers of ME/CFS and Long COVID. Dr. Iwasaki’s study focuses on a crucial and emerging area of investigation: the role of autoantibodies—antibodies that mistakenly target a person’s own tissues—in the long-term neurological symptoms seen in patients with ME/CFS. Dr. Iwasaki’s lab will investigate whether these autoantibodies can actually cause symptoms such as fatigue, pain, cognitive issues, and motor dysfunction by introducing patient-derived antibodies into mice and analyzing their effects.
The 2025 Catalyst Awards reflect Solve M.E.’s continued dedication to accelerating scientific breakthroughs, bridging research between ME/CFS and Long Covid, and delivering hope and impact to millions worldwide.
Learn more about the Catalyst Awards here.
