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Also known as Hexagen Antimicrobial
GX-03 · 2 trials · 4 indications
vIGA-AD Success defined as score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 4. All Primary Outcome measures will be evaluated using the Hochberg-method.
75% reduction from baseline in Eczema Area Severity Index (EASI) at Week 4. All Primary Outcome measures will be evaluated using the Hochberg-method.
90% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8. All Primary Outcome measures will be evaluated using the Hochberg-method.
100% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8. All Primary Outcome measures will be evaluated using the Hochberg-method.
Time to achieve a 60% reduction in viral load from baseline.
To evaluate the incidence rate(s) of non-serious and serious adverse events associated with administration of the study product.
| Arm | Type | Description |
|---|---|---|
| GX-03 | EXPERIMENTAL | Treatment Arm |
| Vehicle | EXPERIMENTAL | Vehicle Control |
| Treatment of hospitalized patients with laboratory-confirmed COVID-19 | EXPERIMENTAL | Hospitalized patients with laboratory-confirmed COVID-19 using GX-03 administered intranasally TID for 5 days. |
| Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19 | PLACEBO_COMPARATOR | Hospitalized patients with laboratory-confirmed COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 5 days. |
| Prevention of SARS-COV-2 in Health Care Providers | EXPERIMENTAL | Health care providers with laboratory-confirmed negative COVID-19 using GX-03 administered intranasally TID for 10 days. |
| Placebo Prevention of SARS-COV-2 in Health Care Providers | PLACEBO_COMPARATOR | Health care providers with laboratory-confirmed negative COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 10 days. |
| Name | Type | Description |
|---|---|---|
| GX-03 | COMBINATION_PRODUCT | Topical ointment |
| Vehicle | OTHER | Ointment carrier |
| Petrolatum ointment | DRUG | Viscous ointment similar in form to study drug. |
Participants must meet all of the following criteria: * Adults aged 18 to 80 years, inclusive * Male or female subjects in good general health as determined by medical history * Subjects meeting all of the following baseline criteria: * Baseline EASI Score of ≥ 1.1 * Baseline vIGA-AD Score of ...
GX-03 is an investigational small molecule being studied for two indications: COVID-19 and moderate to severe atopic dermatitis (eczema). It is being developed by Turn Therapeutics Inc. (TTRX) and is currently in Phase 2 clinical trials for both conditions.
GX-03 targets IL-36, a cytokine involved in inflammatory responses. By modulating IL-36 signaling, the drug aims to address the inflammatory components of atopic dermatitis and potentially COVID-19, though the exact mechanism in each condition is still under investigation.
GX-03 is developed by Turn Therapeutics Inc., a biopharmaceutical company listed on the stock exchange under the ticker TTRX. The company is conducting Phase 2 clinical trials to evaluate the drug's safety and efficacy in COVID-19 and atopic dermatitis.
GX-03 is in Phase 2 clinical development. It is not FDA approved and remains an investigational drug. Two Phase 2 trials are associated with GX-03: one completed study for COVID-19 and one actively recruiting study for atopic dermatitis.
GX-03 is being evaluated in two Phase 2 trials. NCT04951349, a completed study in Panama, tested intranasal GX-03 for COVID-19 treatment and prevention with 85 participants. NCT07355075, an active trial in the United States, is a double-blind, randomized, vehicle-controlled study of GX-03 in 190 adults with moderate to severe atopic dermatitis.
No alternative names for GX-03 have been reported. The drug is consistently referred to as GX-03 across its clinical trial documentation and by its developer, Turn Therapeutics Inc.