Scioderm

{{Short description|American pharmaceutical company}}

{{COI|date=September 2015}}

{{Use dmy dates|date=September 2015}}

{{Infobox company

| name = Scioderm

| type =

| industry = Pharmaceuticals

| founded = {{start date|2013|04}}

| founders = Robert Coull, CA, CBV
Robert Ryan, Ph.D.

| hq_location =

| hq_location_city = Durham, North Carolina

| hq_location_country =

| area_served =

| key_people =

| products = SD-101 for epidermolysis bullosa (EB)

| brands = Zorblisa

| services =

| owner =

}}

Scioderm, acquired by Amicus Therapeutics in 2015, was a rare disease company focused on developing a treatment for Epidermolysis Bullosa (EB), a rare genetic disease characterized by extremely fragile skin and recurrent blister formation. There are currently no approved therapies for EB. Scioderm was developing a topical treatment known as SD-101, or Zorblisa, aimed at triggering wound reduction and closure, and a reduction in body surface area coverage of blisters and lesions.{{ cite news | title=Family of NYC girl with skin-blistering condition sees hope in new drug | author=Hein, Alexandria | publisher=FoxNews.com | date=28 July 2015 | url=https://www.foxnews.com/health/family-of-nyc-girl-with-skin-blistering-condition-sees-hope-in-new-drug/ }}

Epidermolysis Bullosa, sometimes referred to as "Butterfly Skin",{{ cite news | title=People with 'Butterfly' Skin Condition Triumph Through Pain | author=Lupkin, Sydney | publisher=Good Morning America | date=22 February 2013 | url=https://abcnews.go.com/Health/butterfly-skin-condition-pain-triumph/story?id=18558903 }} is a rare genetic connective tissue disorder that, in all forms, results in extremely fragile skin that blisters or tears at the slightest friction or trauma.{{ cite news | title=Biopharma company Scioderm chooses Clearpath as its agency partner | author=Nichols, Laura | publisher=PR WEEK | date=18 March 2014 | url=http://www.prweek.com/article/1285754/biopharma-company-scioderm-chooses-clearpath-its-agency-partner }} EB typically manifests at birth or early childhood.{{cite web | url=http://www.sderm.com/about/about-us/ | title=About | publisher=Scioderm | website=sderm.com | access-date=29 August 2015 | archive-date=31 August 2015 | archive-url=https://web.archive.org/web/20150831000859/http://www.sderm.com/about/about-us/ | url-status=dead }} According to the Dystrophic Epidermolysis Bullosa Research Association of America (DEBRA), an estimated 1 out of every 20,000 live births are affected with some type of EB and the disorder occurs in every racial and ethnic group throughout the world and affects both sexes equally.{{cite web | url=http://www.debra.org/understanding | title=Understanding EB | publisher=DEBRA | website=debra.org | access-date=28 August 2015 | archive-date=6 September 2015 | archive-url=https://web.archive.org/web/20150906231840/http://www.debra.org/understanding | url-status=dead }}

In Scioderm's initial open-label Phase 2 study conducted in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB, the application of SD-101 resulted in complete closure of 88% of target chronic lesions within one month, in addition to a 57% reduction in Body Surface Area (BSA) coverage of lesions and erosions after 3 months of daily treatment.{{ Cite press release | url=http://www.biospace.com/News/scioderms-investigational-new-drug-ind-application/287690 | title=Scioderm's Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA | publisher=Scioderm | agency=BioSpace | date=14 February 2013 }}{{Cite press release | url=http://www.sderm.com/wp-content/uploads/2013/04/Press-Release-May-2-2013-Breakthrough-Final.pdf | title=Scioderm's SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa | publisher=Scioderm | website=sderm.com | date=29 April 2013 | access-date=28 August 2015 | archive-date=9 September 2015 | archive-url=https://web.archive.org/web/20150909193425/http://www.sderm.com/wp-content/uploads/2013/04/Press-Release-May-2-2013-Breakthrough-Final.pdf | url-status=dead }}

SD-101, now owned by Amicus Therapeutics, is currently in Phase 3 clinical development to evaluate Zorblisa as a therapy for the treatment of lesions and blistering associated with Epidermolysis Bullosa.{{ cite web | url=http://www.debra.org/research-trials | title=DEBRA Current Research Trials | publisher=DEBRA | website=debra.org }} Zorblisa is the first drug to ever enter Phase 3 development for the treatment of EB. Stem cell research for Epidermolysis Bullosa is also underway by researchers at the University of Minnesota pursuant to an open-label Phase 2 trial.{{ cite web | url=https://clinicaltrials.gov/ct2/show/NCT01033552? | title=Stem Cell Transplants for Epidermolysis Bullosa | date=7 February 2023 | publisher=ClinicalTrials.gov }}

In April 2013 Scioderm received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its topical treatment, SD-101 for Epidermolysis Bullosa. As a result of receiving Breakthrough therapy designation for SD-101, Scioderm was named a 2013 "Fierce Top 15" company by FierceBiotech.{{ cite news | title=Scioderm - 2013 Fierce 15 | author=Carroll, John | publisher=FierceBiotech | date= 24 September 2013 | url=http://www.fiercebiotech.com/special-reports/scioderm-fiercebiotechs-2013-fierce-15 }}{{ cite news | title=FierceBiotech's 2013 Fierce 15 | author=Carroll, John | publisher=FierceBiotech | date=24 September 2013 | url=http://www.fiercebiotech.com/special-reports/fiercebiotechs-2013-fierce-15 }} Prior to Scioderm's receipt of the FDA's Breakthrough therapy designation for SD-101, it had only been given to high-profile pharmaceutical companies such as Johnson & Johnson, Merck and Novartis.{{ cite news | title=Biotech upstart joins Big-Pharma cast on high profile 'breakthrough' stage | author=Carroll, John | publisher=FierceBiotech | date=30 April 2013 | url=http://www.fiercebiotech.com/story/biotech-upstart-joins-big-pharma-cast-high-profile-breakthrough-stage/2013-04-30}} In addition to Breakthrough therapy designation, Scioderm received Orphan Drug Designation from both the FDA and from the European Medicines Agency (EMA) for its EB treatment.{{Cite press release | title=Scioderm To Present Data From Phase 2b Study Of Zorblisa (SD-101) At The Debra International Congress | publisher=Scioderm | website=sderm.com | date=9 September 2014 | url=http://www.sderm.com/wp-content/uploads/2014/09/Press-Release-for-debra-International-congress-Paris-France-CLEAN.pdf | access-date=9 September 2015 | archive-date=23 November 2015 | archive-url=https://web.archive.org/web/20151123065720/http://www.sderm.com/wp-content/uploads/2014/09/Press-Release-for-debra-International-congress-Paris-France-CLEAN.pdf | url-status=dead }}