This year we have presented our Investigational New Drug (IND) application for our lead candidate, MyMD-1, to the US Food and Drug Administration. We are proceeding with a Phase 1 trial in healthy human volunteers for the treatment of Hashimoto’s Thyroiditis. In addition to this Phase 1 trial, we are developing pre-clinical programs for other devastating conditions. We believe our unique approach could revolutionize treatment for many autoimmune disorders where the underlying pathology is driven or enhanced by the regulation of immuno-metabolic systems. These disorders often have a high unmet need for safe, effective therapies.
Work performed at The Johns Hopkins School of Medicine, recently published in the Journal of Immunology, has shown that MYMD-1 specifically targets subsets of T lymphocytes called effector T cells by reducing their activity. Effector T cells are involved in mediating a broad spectrum of autoimmune diseases. The studies further showed that MYMD-1 has a broad spectrum effect on the immunometobalic system including, suppressing in vitro the production of the pro-inflammatory cytokine TNF-alpha by effector T helper 1 T lymphocytes (Th1 cells), reducing nitrite and increasing hydrogen sulfide. Multiple mouse disease models have demonstrated that MYMD-1 decreased the incidence and severity of thyroiditis, significantly attenuated the clinical severity of MS, and significantly extended longevity and reversed physical signs of aging.
MYMD-1 is a small molecule with a benign safety profile as demonstrated in pre-clinical studies. Phase I human safety and dosing trials are scheduled for completion in 2019.
As an immunometabolic regulator, MYMD-1 uniquely targets the rate of cellular oxidation as the underlying cause (as opposed to the symptom) of many currently uncured diseases. Accordingly, the therapeutic scope of our lead candidate is being expanded through ongoing preclinical studies focused on additional age-related diseases, virtually all autoimmune diseases, Alzheimer’s disease, various cancers and heart disease.
In vitro and in vivo murine model studies have demonstrated that without measurable toxicity, MYMD-1:
- Regulates Th1 and the release of TNF-a in a dose dependent manner
- Ameliorates autoimmune thyroiditis
- Prevents and reverses multiple sclerosis
- Improves vital health signs
- Reverses aging, as measured by key markers for cellular aging and by murine longevity studies.