Evaluation of ATx201 as a Topical Antibiotic Agent

UNION Therapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Infection, Bacterial

Treatments

Drug: ATx201 dermal formulations 2%

Study type

Interventional

Funder types

Industry

Identifiers

NCT03009734

DECOLAD

Details and patient eligibility

About

AntibioTx is developping ATx201 as a topical product for treatment of skin infections, including infected atopic dermatitis.

Full description

Treatment of skin infections, including infected atopic dermatitis, is plagued by inactivity of or resistance towards the main topical antibiotics. Accordingly, the infections are either not effectively treated or harsher systemic antibiotics with side effects are needed.

Infections in atopic dermatitis are predominantly caused by Staphylococcus aureus and various species of Streptococcus. ATx201 is a potent antibiotic against these and other organisms. ATx201 overcomes current resistance problems such as methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE) as well as resistance towards all topical antibiotics. ATx201 also exhibits an extraordinarily strong ability to delay the onset of de novo resistance compared to currently marketed antibiotics.

The study is a combined Phase I/II study with 36 healthy volunteers and 40 patients.

The primary objective is to demonstrate the safety and tolerability of new topical formulations of ATx201 in healthy volunteers, and in a population of patients with infected atopic dermatitis. Efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4 and 7 days of treatment will be evaluated. In Phase I of the study, three formulations of ATx201 including the respective Placebos will be applied to healthy volunteers. One formulation will advance into Phase II, where patients will be treated with the respective formulation or Placebo.

Enrollment

73 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

General inclusion criteria:

Signed and dated informed consent has been obtained
Age 18 - 70 years
Male or female
Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior trial treatment
Female subjects of childbearing potential must be willing to use effective contraceptive at trial entry until completion
Male subjects must agree to use adequate contraception for the duration of the trial

Additional inclusion criteria for Phase II of the study:

Localized disease (e.g. flexural eczema in a more or less symmetrical distribution on arms) where two individual lesions each covering an area between 10-200 cm2 and where each individual lesion has an investigators global assessment score between 1-3.
Additional localized lesion of area between 10-200 cm2 and where the individual lesion has an investigators global assessment score between 1-3.
Total localized disease not exceeding 20 % body surface area
Colonization of lesions with S.aureus as determined by cultivation

General exclusion criteria

Clinically relevant abnormalities in the laboratory testing, vital signs, ECG ( Phase I only) or physical examination
Presence of any skin condition (scars, tattoos,...) that would interfere with the placement of study medication
History of irritation to topical products
Current acute or chronic disease unless considered clinically irrelevant by the Investigator
Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
Positive HIV serology or evidence of active hepatitis
Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drugs (test, reference)
History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
caffeine (>5 cups coffee/tea/day) or tobacco abuse (consumption of 5 or more cigarettes/week)
abnormal or special diet (e.g. vegetarian diet)
Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal
Subject considered unable or unlikely (per Investigator judgment) to comply with safety and PK profiling requirements (follow-up visits)
Subjects who are pregnant (as determined by a positive pregnancy test at the screening visit) or lactating
Participation in another clinical trial with an investigational day within 4 weeks before screening

Additional exclusion criteria for Phase I of the study:

Regular use of medications
Use of any dermatological drug therapy on the arms within 14 days before day 1 of this study

Additional exclusion criteria for Phase II of the study:

Treatment with antibiotics (systemic or topical) within the past 3 months and during the study
Treatment with drugs that affect the immune system within the past 3 months and during the study
Treatment with topical steroids and calcineurin inhibitors 1 week before and during the study treatment period
Treatment with systemic steroids within the past month and during the study
Use of disinfectant soaps within 1 week before screening and during the study treatment period