What's New at GSNO Thera

2021-2022 Updates

Identified and Characterized In Vivo a Novel, Patented by GSNO Therapeutics, Lead Compound, GTI-850, which inhibits S-Nitrosoglutathione Reductase (GSNOR), an Enzyme That Degrades S-Nitrosoglutathione (GSNO), the Major Protein S-nitrosylating Molecule in Cells.

New Understanding That GSNO, a Natural, Non-Toxic, Highly Bioavailable Metabolite Essential for Life, Is the “Real” API of GSNOR Inhibition Therapeutic Efficacy Hence: Our name–GSNO Therapeutics.

New Understanding that the Multiple Therapeutic Benefits of GSNORi (now 56) and Activity in 26 Animal Models of Disease are Related, in Part, to the Inhibition of Fibrosis, Autoimmunity, Oxidative Stress, Inappropriate Inflammation, and neurodegeneration, plus C-GMP activation, and other actions.

Filed Broad International Patent Rights for GTI-850 and Related Molecules.

Characterized Clean Safety Data for GTI-850.

Understanding Novel PK/PD Relationships of GTI-850 and Active Routes of Administration: Oral, Topical, Intravitreal, IP, and IV.

GTI-850 and Other GSNOR Inhibitors Facilitate, by Preventing Its Breakdown, The Increased Abundance of GSNO, the Therapeutically Active Molecule That Nitrosylates Signal, and Other Critical Proteins To Regulate Them.

Identified 56 Therapeutic Activities of GSNO and GSNORis, Including GTI-850 (See List Under the Science Section).

Added GSNORi GTI-850 Efficacy in Animal Models:

1. Topical Ocular Anti-Inflammatory Activity Equal to or Superior to Prednisolone Acetate, a Steroid Standard of Care. Suggests That GTI-850 Could Become a Safe Replacement for Steroids in Ocular and Other Therapeutic Applications.

2. Strong Oral Therapeutic Activity in an IBD Model Equal to or Better Than Two Standards of Care Drugs. These Data Add to the List of Autoimmune Therapeutic Activities of GSNORis and Suggest That GTI-850 Could Become a Safe, Autoimmune Inhibiting Alternative to Existing Drugs, Including Steroids or Janus kinase (JAK) Inhibitors with More Mechanisms of Therapeutic Action and without Their Toxicities.

3. Targeted Clinical Trials with GTI-850 in Autoimmune Conjunctivitis and Dry Eye by Topical Application As Disease Indications With Large Unmet Medical Needs, Expanding Markets, and Faster and Less Expensive Clinical Development to Both Proof of Clinical Concept and a Marketable Drug, GTI-850.

4. GTI-850 was Chosen by the Interventional Testing Program (ITP) of the National Institurtes of Aging (NIA) to Test Whether GTI-850 can Extend Lifespan and Healthspan in aged mice.

5. GSNO Therapeutics just received an NIH grant to study GTI-850 in aged, diabetic vervet monkeys to determine whether the drug will increase their healthspan, biomarkers of aging, and perhaps, lifespan.

6. Since FDA Will Not Allow a Drug Approval for Aging, We Have Chosen to Pursue Clinical Trials In at least one of 3 Age-Related Diseases, with Relatively Quick and Inexpensive Clinical Trials.

Homeostasis:

The Object of GSNORi Therapy Is To Restore Protein S-Nitrosylation Homeostasis by Reducing, but Not Eliminating, the Activity of GSNOR. That Is Why GSNOR Knock-Outs Are Not a Good Model for GSNOR Inhibiting Drugs Because the Drugs Only Reduce GSNOR Activity Into a Homeostatic Range Rather Than Eliminate It As Knock-Outs Do.

Identified 56 Therapeutic Activities of GSNO and GSNORis, Including GTI-850 (See List Under the Science Section).

Preclinical POC:

From Both GSNO Therapeutics’ Work and the Literature, GSNORis Are Active in 26 Animal Models of Disease and 2 Human Diseases (400+ Phase II Patients) With No Toxicity to Date.

Added GSNORi GTI-850 Efficacy in New Animal Models:

Ophthalmology:

GTI-850: Topical Ocular Anti-inflammatory Activity Equal to or Superior to Prednisolone Acetate, a Steroid Standard of Care.

GTI-850, a Non-Steroid, Had No Ocular Toxicity in the Study, Whereas Prednisolone Acetate Was Toxic.

GTI-850 Could Become a Safe Replacement for Steroids in Ocular and Multiple Other Therapeutic Applications.

GSNORi Inhibits Microglial Activation and Retinal Neurodegeneration.

Ophthalmic Clinical Trials:

Targeted Clinical Trials in Autoimmune Conjunctivitis and Dry Eye by Topical Application As Disease Indications With Large Unmet Medical Needs, Expanding Markets, and Faster and Less Expensive Clinical Development to Both Proof of Clinical Concept and a Marketable Drug, GTI-850.

Inflammatory Bowel Diseases:

Strong oral therapeutic activity in an IBD model is equal to or better than two standards of care drugs. These data add to the list of autoimmune therapeutic activities of GSNORis and suggest that GTI-850 could become a safe, autoimmune inhibiting alternative to existing drugs, including steroids and JAK inhibitors, with more mechanisms of therapeutic action.

Aging:

Given the Activity of GSNORis and GTI-850 in two human diseases and 26 Animal Models of Diseases Related to Aging, We Are Also Developing Clinical Development Plans For Phase I And II Clinical Trials of GTI-850 in the Age-Related Diseases Of Periodontal Disease And Hearing Loss. Both Aging Diseases Have Inflammatory And, Perhaps More Importantly, Oxidative Stress-Based Pathophysiology. GTI-850 Reduces Both Of Those Disease Drivers And Many Others (See the Science Section). The Periodontal And Hearing Loss Trials Will Be Relatively Short And Inexpensive.