Dr. Carl Gunnar Gottschalk

Biography: r. C. Gunnar Gottschalk is the CEO and Managing Board Member of Simmaron Research Inc. (SRI), a 501(c)(3) biomedical research foundation established in 2011 in Incline Village, Nevada. He earned his Ph.D. in Neuroscience from Rush University in 2020 and currently serves as Section Chief of Translational Science. His research focuses on the design and execution of mechanism-based clinical trials across a range of therapeutic areas, including his ongoing trial investigating the efficacy of low-dose rapamycin (sirolimus) in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and other infection-associated chronic conditions (IACCs) (NCT06257420).

Dr. Gottschalk is the co-founder of Sotira Scientific and co-inventor of KEPTIDE (U.S. Patent No. 11,078,242), an intranasal peptide therapy developed for the prevention and treatment of SARS-CoV-2 infection. He is also the co-founder and CEO of Simmpyra Pharmaceuticals, LLC, an oncology-focused startup based at the University of Wisconsin-Milwaukee’s Milwaukee Institute for Drug Discovery. Simmpyra is developing patent-pending STAT3-targeting compounds for the treatment of triple-negative breast cancer (TNBC).

Since 2021, Dr. Gottschalk has led a highly productive collaboration between SRI and the University of Wisconsin-Milwaukee. This partnership has attracted substantial support from private donors, establishing a financially sustainable research model. Over the past five years, the collaboration has resulted in six major foundation grants, one NIH R21 award, and direct research funding for the UWM Department of Chemistry. Dr. Gottschalk’s leadership has been instrumental in advancing research on ME/CFS, Long COVID, IACCs, and early-stage therapeutic development in peptide biology and autophagy-modulating compounds.

Research Interest: ME/CFS is a highly heterogeneous disease in terms of its etiological factors, clinical manifestations, and course. Factors such as the patient’s history, disease onset, duration of the disease, comorbidities, and age contribute to the disease pathogenesis. My aim is to identify a clinical biomarker (s) that can effectively correlate the metabolic impairments in these patients with their clinical symptoms. Identification, characterization, and validation of biomarkers such as cytokines, chemokines, auto-antibodies, and small molecular metabolites are my primary research interest. I employ an array-based approach for high-throughput screening of hundreds of these molecular factors followed by ELISA-based validation of a specific target. My primary resource is Dr. Peterson’s large biobank of serum, plasma, and cerebrospinal fluid (CSF) of ME/CFS patients.

Publications:

1. B. T. Ruan et al., Low-dose rapamycin alleviates clinical symptoms of fatigue and PEM in ME/CFS patients via improvement of autophagy: a pilot study. Journal of Translational Medicine 23, 1148 (2025) (Corresponding author).

2. Gottschalk, C. G., Jana, M., Roy, A., Patel, D. R., and Pahan, K. (2021) Gemfibrozil Protects Dopaminergic Neurons in a Mouse Model of Parkinson's Disease via PPARα-Dependent Astrocytic GDNF Pathway. The Journal of neuroscience 41, 2287-2300\ 2021.

2. Gottschalk, C. G., Roy, A., Jana, M., Kundu, M., and Pahan, K. (2019) Activation of Peroxisome Proliferator-Activated Receptor-α Increases the Expression of Nuclear Receptor Related 1 Protein (Nurr1) in Dopaminergic Neurons. Mol Neurobiol 56, 7872-7887.

3. Mandarano, A. H., Maya, J., Giloteaux, L., Peterson, D. L., Maynard, M., Gottschalk, C. G., and Hanson, M. R. (2020) Myalgic encephalomyelitis/chronic fatigue syndrome patients exhibit altered T cell metabolism and cytokine associations. J Clin Invest 130, 1491-1505

4. Hornig, M., Montoya, J. G., Klimas, N. G., Levine, S., Felsenstein, D., Bateman, L., Peterson, D. L., Gottschalk, C. G., Schultz, A. F., Che, X., Eddy, M. L., Komaroff, A. L., and Lipkin, W. I. (2015) Distinct plasma immune signatures in ME/CFS are present early in the course of illness. Science advances 1.

5. Gottschalk, G., Keating, J., Kesler, K., Knox, K., and Roy, A. (2020) Intranasal Administration of ACIS KEPTIDE™ Prevents SARS-CoV2-Induced Acute Toxicity in K18-hACE2 Humanized Mouse Model of COVID-19: A Mechanistic Insight for the Prophylactic Role of KEPTIDE™ in COVID-19.BioRxiv 2020

6. Gottschalk, G., Keating, J., Kessler, K., Luan, C., Knox, K., and Roy, A. (2020) ACIS, A Novel KepTide™, Binds to ACE-2 Receptor and Inhibits the Infection of SARS-CoV2 Virus in vitro in Primate Kidney Cells: Therapeutic Implications for COVID-19. BioRxiv 2020

7. Gottschalk, G., Knox, K., and Roy, A. (2021) ACE2: At the crossroad of COVID-19 and lung cancer. Gene Rep 23, 101077

8. Unger, E. R., Lin, J. S., Tian, H., Natelson, B. H., Lange, G., Vu, D., Blate, M., Klimas, N. G., Balbin, E. G., Bateman, L., Allen, A., Lapp, C. W., Springs, W., Kogelnik, A. M., Phan, C. C., Danver, J., Podell, R. N., Fitzpatrick, T., Peterson, D. L., Gottschalk, C. G., and Rajeevan, M. S. (2017) Multi-Site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM): Design and Implementation of a Prospective/Retrospective Rolling Cohort Study. American journal of epidemiology 185, 617-626.

Honors and Award:

Ramsay Award 2022 from SolveME.

NIHR21 Award 2023.

Catalyst Award from SolveME 2025.

Patent: Peptides for Covid-19 prevention and treatment (#11,078,242) 2020