Amryt Pharma is currently conducting a global phase III study-Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (the EASE study), to investigate whether Oleogel-S10 (AP101) is safe and efficacious for the treatment of EB wounds in patients with Dystrophic and Junctional EB, and Kindler Syndrome.
Oleogel-S10 (AP101), has not been adequately studied and is not approved for the treatment of wounds related to EB. It must be studied further to learn more about its safety and effectiveness in the treatment of wounds in patients with certain types of inherited of Epidermolysis Bullosa (Dystrophic, Junctional, and Kindler Syndrome).
Oleogel-S10 (AP101) was developed by Amryt Pharma, (trade name, Episalvan®) and was approved in the European Union in January 2016 for the treatment of partial thickness wounds in adults. A topical gel, Oleogel-S10 (AP101), contains 90% Sunflower oil and 10% dry birch bark extract with the active ingredients, triterpene extracts, which is predominately betulin (72%-88%).
The EASE study protocol requires participating patients to apply Oleogel-S10 or placebo (sunflower oil vehicle gel) to an eligible primary target wound identified by the Study Investigator in addition to all other EB wounds. Patients are allowed to apply the study medication according to their preferred schedule of wound dressing changes ranging from every day to as long as every 4 days. Patients may use their choice of non-adhesive dressing.
After an initial 3 months of treatment with either Oleogel-S10 (AP101) or vehicle (placebo) gel, all patients will receive Oleogel-S10 (AP101) in an open label, 24-month safety extension. Patients will be asked to comply with the study protocol and complete all scheduled study visits.
The EASE study protocol requires participating patients to apply Oleogel-S10 or placebo (sunflower oil vehicle gel) to an eligible primary target wound identified by the Study Investigator in addition to all other EB wounds. Patients are allowed to apply the study medication according to their preferred schedule of wound dressing changes ranging from every day to as long as every 4 days. Patients may use their choice of non-adhesive dressing.
After an initial 3 months of treatment with either Oleogel-S10 (AP101) or vehicle (placebo) gel, all patients will receive Oleogel-S10 (AP101) in an open label, 24-month safety extension. Patients will be asked to comply with the study protocol and complete all scheduled study visits.
Additional Updates from Amryt Pharma
Amryt EASE study opens for recruitment at Amjad Plastic Research, Miami, FL, Raoof Dermatology/Encino Research Center in Encino, CA, and Masonic Children’s Hospital, University of Minnesota, Minneapolis.
Amryt, a company focused on developing products that help to improve the lives of patients where there is a high unmet medical need, is pleased to announce that Dr. Kristen Hook, MD, Masonic Children’s Hospital, University of Minnesota, Minneapolis; Dr. Joseph Raoof, Raoof Dermatology/Encino Research Center, Encino, CA; and Ibrahim Amjad, MD, at Amjad Plastic Research, Miami, FL; are now open to recruit patients with Epidermolysis Bullosa (EB) into the Global EASE study. The EASE study is investigating Oleogel-S10, a topical treatment for the wounds associated with inherited EB.
These locations join Leslie Castelo-Soccio, MD, Ph.D., Children’s Hospital of Philadelphia, Philadelphia, PA; Jordan Slutsky, MD, Stony Brook Dermatology, Stony Brook, NY; Anna Bruckner, MD, Children’s Hospital of Colorado in Denver; and John Browning, MD, Texas Dermatology and Laser Specialist in San Antonio, as study sites for Amryt’s ph III trial in EB, EASE. All of these sites are open to recruit eligible patients with Epidermolysis Bullosa (EB) into the global EASE study.
Up to 10 trial sites are planned in the US and initiation of these sites is a significant milestone in accelerating patient recruitment into the EASE study. The EASE study has existing trial sites in Europe, Australasia, Latin America and the Middle East. The US Food and Drug Administration ("FDA") granted Investigational New Drug ("IND") clearance for the EASE study in September 2018.
Up to date information about the EASE study, including study design, study site information, and how to contact a site directly is available on clinicaltrials.gov
Additional EASE Trial Updates:
A pre-specified recent interim efficacy analysis occurred when 50% of study patients were enrolled into the EASE study. The purpose of this analysis was to check that sufficient patients were enrolled in the study to detect a difference in the efficacy on wound healing of Oleogel-S10 compared with placebo with adequate statistical power. The recommendation of an independent data monitoring committee (IDMC) was to increase in the number of evaluable subjects in the study from 182 to a total of 230.
An interim safety analysis was also conducted. The IDMC interim safety analysis has recommended that sites can now include enrollment of infants and children with EB between the ages of 21 days to 4 years of age into the trial. The IDMC’s interim safety analysis was conducted using pharmacokinetic (“PK”) data received from patients already enrolled in the trial (aged four years and older). Amryt will begin the recruitment process for infants and children into EASE immediately. The EASE trial is the largest ever global Phase III study conducted in patients with EB.
Amryt is encouraged by this news. The modest increase in patients required for the study and extending the age eligibility criteria is positive news and a significant step forward in addressing the unmet need in this devastating condition, which is present from birth in most cases. Amryt would like to thank sincerely the patients, families and clinical investigators involved in the EASE trial.
Amryt EASE study opens for recruitment at Children’s Hospital of Philadelphia (CHOP), Philadelphia, PA and Stony Brook Dermatology, Stony Brook, New York
Amryt, a company focused on developing products that help to improve the lives of patients where there is a high unmet medical need, announce that Leslie Castelo-Soccio, MD, Ph.D., Children’s Hospital of Philadelphia, and Jordan Slutsky, MD, Stony Brook Dermatology, Stony Brook, NY, join Anna Bruckner, MD, Children’s Hospital of Colorado in Denver, CO, and John Browning, MD, Texas Dermatology and Laser Specialist, San Antonio, TX. As study sites for Amryt’s Phase III trial in EB, EASE. All of these sites are open to recruit eligible patients with Epidermolysis Bullosa (EB) into the Global EASE study. The EASE study is evaluating Oleogel-S10, an investigational topical treatment for the wounds associated with inherited EB.
Up to 10 trial sites are planned in the US and initiation of Children’s Hospital of Philadelphia (PA) and Stony Brook Dermatology (Stony Brook Medicine), Stony Brook, NY is a significant milestone in accelerating patient recruitment into the EASE study. The EASE study has existing trial sites in Europe, Australasia, Latin America and the Middle East. The US Food and Drug Administration ("FDA") granted Investigational New Drug ("IND") clearance for the EASE study in September 2018.
Up to date information about the EASE study, including study design, study site information, and how to contact a site directly is available on clinicaltrials.gov.
Amryt is encouraged by this news. The opening of additional new study sites, along with the recent outcome of the pre-specified interim efficacy analysis resulting in the modest increase in patient enrollment to 230 subjects required for adequate statistical power. In addition, the pre-specified safety analysis results extending the age eligibility criteria to patients aged 21 days and older, is positive news and a significant step forward in addressing the unmet need in this devastating condition. The EASE trial is the largest ever global Phase III study conducted in patients with EB. Amryt would like to thank sincerely the patients, families and clinical investigators involved in the EASE trial.
Amryt EASE study opens for recruitment at Children’s Hospital Colorado, Denver.
Amryt, a company focused on developing products that help to improve the lives of patients where there is a high unmet medical need, today announced that Anna Bruckner, MD, Children’s Hospital Colorado in Denver, CO, joins John Browning, MD, Texas Dermatology and Laser Specialist, San Antonio, TX and is now open to recruit patients with Epidermolysis Bullosa (EB) into the Global EASE study. The EASE study is investigating Oleogel-S10, a topical treatment for the wounds associated with inherited EB.
Up to 10 trial sites are planned in the US and initiation of Children’s Hospital Colorado is a significant milestone in accelerating patient recruitment into the EASE study. The EASE study has existing trial sites in Europe, Australasia, Latin America and the Middle East. The US Food and Drug Administration ("FDA") granted Investigational New Drug ("IND") clearance for the EASE study in September 2018.
Up to date information about the EASE study, including study design, study site information, and how to contact a site directly is available on clinicaltrials.gov
A recent interim efficacy analysis occurred when 50% of study patients were enrolled into the EASE study. The purpose of this analysis was to check that sufficient patients were enrolled in the study to detect a difference in the efficacy on wound healing of Oleogel-S10 compared with placebo. The recommendation of an independent data monitoring committee (IDMC) was to increase in the number of evaluable subjects in the study from 182 to a total of 230.
An interim safety analysis has also been conducted. The IDMC interim safety analysis has recommended that sites can now enroll infants and children with EB between the ages of 21 days to 4 years of age in to the trial. The IDMC’s analysis was conducted using pharmacokinetic (“PK”) data received from patients already enrolled in the trial (aged four years and older).
Amryt will begin the recruitment process for infants and children into EASE immediately. The EASE trial is the largest ever global Phase III study conducted in patients with EB.
Amryt is encouraged by the news. The modest increase in patients required for the study and extending the age eligibility criteria is positive news and a significant step forward in addressing the unmet need in this devastating condition, which is present from birth in most cases. Amryt would like to thank sincerely the patients, families and clinical investigators involved in the EASE trial.
- Male and female patients with the following subtypes of inherited EB: junctional EB (JEB), dystrophic EB (DEB), and Kindler syndrome aged ≥21 days,
- Patients with an EB target wound (i.e., EB partial thickness wound of 10 cm² to 50 cm² in size aged ≥21 days and <9 months),
- Patient and/or his/her legal representative has/have been informed, has/have read and understood the patient information/informed consent form, and has/have given written informed consent,
- Patient and/or his/her legal representative must be able and willing to follow study procedures and instructions.
- Please click the link below for exclusion criteria.
