Simmaron Research

On this day, May 12 #WorldMEDay, on behalf of everyone at Simmaron Research Inc. @redefiningMECFS, @ProfAvikRoy and @ggottschalkphd want to thank and recognize all of the patients who have participated in our clinical research protocols, particularly in our low-dose rapamycin projects . Your trust, courage, and commitment make this work possible. We are deeply grateful and honored to do this work alongside you.

Why placebo trials in #ME and #LongCovid? It’s how INDUSTRY and PHARMA make investments. Patients need treatments, and we need drug companies to invest in our disease. Once we have 1 successful placebo-controlled trial, we’ll attract industry research. Our placebo RAPAMYCIN trial has an opportunity to be successful, and we’re testing biomarkers to identify the subset that responds. Even if it doesn’t work for all #MECFS patients, it could be a breakthrough for us all. Help us do it! simmaronresearch.com/donate

Why placebo trials for #MECFS and #LongCovid? We have no FDA-approved treatment, because no placebo trial has been successful. We need them to make breakthroughs happen. It’s how drugs get approved. Early observational data is encouraging — but it doesn’t change medicine. Rigorous testing does. Our step-wedge design allows comparison of RAPAMYCIN with placebo while ensuring all participants eventually receive treatment. If successful, we can prove which subset responds to rapamycin and change medicine, finally. #ClinicalTrial

1/ @SenMarkey, @SenTimKaine, and @SenDuckworth are championing a FY27 “Dear Colleague” letter for $210M+ in #LongCOVID research — and it includes #MECFS, #POTS, and #dysautonomia by name. Deadline is FRIDAY. 🧵

🔬 ARPA-H for high-risk, high-reward LC + associated research The NIH report language is the piece we've been waiting for. It directs funding to INTERVENTIONAL drug trials, biomarker discovery, & real diagnostic tests + a required NIH Director briefing to Congress w/in 180 days.

@PlzSolveCFS Thank you Solve for spotlighting and supporting our very exciting work!

Watch! Dr. Avik Roy & Dr. Gunnar Gottschalk of @RedefiningMECFS share how six years of work on the molecular mechanisms of #MECFS has led to one of the only ongoing clinical trials specifically designed around a defined biological target. youtu.be/OMmjcTKxivU #MEAwarenessHour

#ME and #LongCovid patients have no FDA approved treatment, no successful placebo-controlled trial, and no accepted biomarker. That's unacceptable. Our placebo-controlled rapamycin trial is a strategic opportunity to change this, and you can help. Read how testing biomarkers with treatment holds so much promise: simmaronresearch.salsalabs.org/placebotrial

Our new placebo-controlled sub-study of rapamycin will measure: • autophagy biomarkers (pATG13 and BECLIN-1) • metabolic pathways using metabolomics • immune cell changes • patient symptoms and wearable data #MECFS and #LongCovid patients deserve evidence-based treatments. Help us fund this rigorous trial so we can get there. simmaronresearch.com/donate

Why low-dose rapamycin? It regulates mTOR and autophagy, pathways that may be disrupted in #MECFS and #LongCOVID. Our trial measures biomarkers, immune signaling, and metabolic changes to understand why some patients improve, and id who is likely to. Help us prove the 1st evidence-based treatment for patients with a placebo-controlled trial. DONATE HERE: simmaronresearch.com/donate #ME #Autophagy #Rapamycin

Our placebo-controlled trial will pay for the costs of rapamycin, placebo, safety tests, biomarker tests and clinical work, to ease patient burden and so the results aren’t influenced by costs. #MECFS and #LongCovid patients need evidence-based treatments, and as a non-profit, we need to raise the funds to get there. A generous donor will double your gift, so let’s do it together and break new ground for treatments. #ME simmaronresearch.com/donate

4️⃣ Now we are launching a double-blind placebo-controlled trial embedded within our Phase II study to test these findings rigorously and develop a biomarker to help predict responders. This is brand new for #MECFS and #Longcovid. 5️⃣ Your support can help generate the evidence needed for evidence-based treatment. Your gift will be doubled by a generous donor! Donate today. simmaronresearch.com/donate 3/3

3️⃣ Early observational data suggests some #ME patients experience improvements in fatigue and post-exertional malaise. We published those results in Journal of Translational Medicine: link.springer.com/article/10.118… 2/3

1️⃣ #MECFS and #LongCOVID affect millions worldwide — yet no @FDA approved treatment exists. 2️⃣ Our team at Simmaron Research is studying low-dose rapamycin, a drug that regulates cellular pathways involved in inflammation and autophagy. 1/3🧵

@dryostradamus @LostSock We are working with expert clinicians to enroll patients: Dr. David Kaufman, @GrachStephanie, Dr. Bella Chheda, Dr. Ilene Ruhoy, @BatemanHorne, others. Our Jnl of Translational Medicine publication of Phase 1 results gives a more detailed case definition: link.springer.com/article/10.118…

@RedefiningMECFS @LostSock Also how are you defining Long COVID and MECFS? And I don’t mean the new onset symptoms 3 months post acute infection definition.

We’re launching a placebo-controlled study of rapamycin for #MECFS and #LongCOVID. Early data from our Phase II trial shows promise — now we must test it under rigorous blinded conditions. Help us make it happen. Donate to support the study. simmaronresearch.com/donate #ME #Rapamycin

ATG13 2022, our initial publication finding pATG13 in a subset of #ME patients: sciencedirect.com/science/articl… 4/4

Mouse Model 2025, demonstrating PEM in animal model resulting from pATG13 (inactive): link.springer.com/article/10.100… 3/4

Our new placebo-controlled rapamycin trial is based on 4 publications of our own work on the mechanisms & biomarkers disrupting autophagy in a subset of #MECFS & #Longcovid patients. Phase 1 of our rapamycin treatment and biomarker trial was published in the selective Jnl of Translational Medicine: link.springer.com/article/10.118…. 1/4 🧵

@AmbrosineShitr2 We appreciate your comment. Based on decades in this disease, most doctors will only take #MECFS or #Longcovid seriously when placebo-controlled trials are successful. We have a chance to be the 1st to do that and identify biomarkers to predict who is likely to improve.

@RedefiningMECFS Drs should just prescribe a low dose to patients and monitor