MALVERN, Pa., Dec. 5, 2017 /PRNewswire/ -- Realm Therapeutics plc (AIM: RLM), a clinical stage biopharmaceutical company focused on leveraging its proprietary immunomodulatory technology, today announced the first patient has been dosed in its Phase 2 study of PR022, the Company's proprietary topical gel formulation of high concentration hypochlorous acid, for the treatment of atopic dermatitis. The trial is being conducted in the United States and top line data is expected in Q3 2018.
The Phase 2 study is a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study assessing the safety and efficacy of multiple doses of PR022 in approximately 120 adult patients with mild-to-moderate atopic dermatitis. Multiple endpoints will be explored, including EASI1 and IGA2, as well as additional assessments of pruritus and quality of life.
"We are extremely pleased to have initiated our first Phase 2 study, which represents a significant milestone for Realm as we continue to execute on our strategy," said Alex Martin, Chief Executive Officer of Realm. "Recently published peer reviewed research has demonstrated PR022's ability to prevent the development of atopic dermatitis-like lesions, reduce existing lesions and associated scratching, and reduce the inflammatory response. PR022 could offer an important alternative to patients suffering from atopic dermatitis and we are very excited about the potential of this new therapy."
1Eczema Area and Severity Index (EASI) is an investigator-assessed tool used to measure the extent (area) and severity of atopic eczema. 2 Investigator Global Assessment (IGA), is an investigator-assessed instrument measuring severity of atopic dermatitis on a 5 grade scale.
About Atopic Dermatitis
Atopic dermatitis, a serious form of eczema, is a chronic, relapsing, inflammatory disease characterised by itchy, inflamed skin, which poses a significant burden on patients' quality of life and on the overall health care system. Patients with atopic dermatitis have impaired function of their skin barrier, and this, combined with skin damage as a result of the intense itching and scratching associated with the disease, makes them at risk for secondary infections due to colonisation with pathogenic bacteria (particularly Staphylococcus aureus) and changes in the skin microbiome. Atopic dermatitis affects up to 20% of children and up to 3% of adults and prevalence numbers continue to increase.
About Realm Therapeutics
Realm Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunomodulatory therapies to protect and improve the lives of adults and children. The Company has initiated drug development programs, based on its proprietary hypochlorous acid technology at high concentrations. The Company believes its formulations have novel immunomodulatory activity with potential application for the treatment of diseases in a number of therapeutic areas, including Dermatology and Ophthalmology.
Forward Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
Contact:
Realm Therapeutics plc Alex Martin, Chief Executive Officer Marella Thorell, Chief Financial Officer and Chief Operating OfficerOutside US: +44 (0) 20 3727 1000US: +1 212 600 1902
Argot Partners Stephanie Marks +1 212 600 1902
FTI Consulting Simon Conway / Mo Noonan+44 (0) 20 3727 1000
N+1 Singer (Nominated Adviser and Broker) Aubrey Powell / Jen Boorer+44 (0) 20 7496 3000
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The Phase 2 study is a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study assessing the safety and efficacy of multiple doses of PR022 in approximately 120 adult patients with mild-to-moderate atopic dermatitis. Multiple endpoints will be explored, including EASI1 and IGA2, as well as additional assessments of pruritus and quality of life.
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"We are extremely pleased to have initiated our first Phase 2 study, which represents a significant milestone for Realm as we continue to execute on our strategy," said Alex Martin, Chief Executive Officer of Realm. "Recently published peer reviewed research has demonstrated PR022's ability to prevent the development of atopic dermatitis-like lesions, reduce existing lesions and associated scratching, and reduce the inflammatory response. PR022 could offer an important alternative to patients suffering from atopic dermatitis and we are very excited about the potential of this new therapy."
1Eczema Area and Severity Index (EASI) is an investigator-assessed tool used to measure the extent (area) and severity of atopic eczema. 2 Investigator Global Assessment (IGA), is an investigator-assessed instrument measuring severity of atopic dermatitis on a 5 grade scale.
About Atopic Dermatitis
Atopic dermatitis, a serious form of eczema, is a chronic, relapsing, inflammatory disease characterised by itchy, inflamed skin, which poses a significant burden on patients' quality of life and on the overall health care system. Patients with atopic dermatitis have impaired function of their skin barrier, and this, combined with skin damage as a result of the intense itching and scratching associated with the disease, makes them at risk for secondary infections due to colonisation with pathogenic bacteria (particularly Staphylococcus aureus) and changes in the skin microbiome. Atopic dermatitis affects up to 20% of children and up to 3% of adults and prevalence numbers continue to increase.
About Realm Therapeutics
Realm Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunomodulatory therapies to protect and improve the lives of adults and children. The Company has initiated drug development programs, based on its proprietary hypochlorous acid technology at high concentrations. The Company believes its formulations have novel immunomodulatory activity with potential application for the treatment of diseases in a number of therapeutic areas, including Dermatology and Ophthalmology.
Forward Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
Contact:
Realm Therapeutics plc Alex Martin, Chief Executive Officer Marella Thorell, Chief Financial Officer and Chief Operating OfficerOutside US: +44 (0) 20 3727 1000US: +1 212 600 1902
Argot Partners Stephanie Marks +1 212 600 1902
FTI Consulting Simon Conway / Mo Noonan+44 (0) 20 3727 1000
N+1 Singer (Nominated Adviser and Broker) Aubrey Powell / Jen Boorer+44 (0) 20 7496 3000
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