Navigation Links
Scioderm's Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
Date:2/13/2013

RALEIGH, N.C., Feb. 13, 2013 /PRNewswire-iReach/ -- Scioderm announced that the US Food and Drug Administration (FDA) has reviewed and allowed the investigational new drug (IND) application for SD-101 to proceed.  SD-101 is a topical treatment being developed for the treatment of Epidermolysis Bullosa (EB).  The Company plans to initiate a Phase 1 study in the coming months, with initiation of the Phase 2B/3 study in EB patients to occur in the second half of 2013. 

EB is a rare genetic condition that in all of its forms, share the prominent manifestation of extremely fragile skin that blisters or tears with the slightest friction or trauma.  The disease affects not only the skin but also many internal organs and bodily systems.  This particular manifestation has led to EB patients being known as Butterfly children due to the analogous nature of the fragility of the skin to the wings of a butterfly.  As of today there is no cure or effective treatment.  Wound care, pain management and preventative bandaging are the only options available for caregivers, usually the parents or other family members.  The more severe forms of the disease lead to scarring, disfigurement, disability and early death, usually before the age of 30. 

"We are excited to reach this important corporate milestone and to advance this novel therapy in the clinic," stated Robert Ryan , Ph.D., Chairman of the Board and Co-Founder of Scioderm.  "We look forward to continuing our rapid development of this program to treat a disease where there are no current effective therapies.  In addition, we look forward to working closely with the FDA to expedite the continuing clinical testing and regulatory review of SD-101." 

 "I am enthused by the results SD-101 has demonstrated and with the rapid progress Scioderm has achieved in bringing this potential treatment to the clinic," said Brett Kopelan , Executive Director of the Dystrophic EB Research Association of America (DebRA ) and father to a 5-year-old girl with recessive dystrophic EB.  "I look forward to working with Scioderm as they work towards improving the quality of life of those with EB by targeting the chronic wounds that are the hallmark of this disease."

About SD-101

SD-101 is a topical cream that has previously demonstrated potential to provide improvement in treating the severe skin effects seen in patients across all EB subtypes.  An open- label study was conducted previously in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB.  The primary outcome measurements were assessment of target wound reduction and closure, and reduction in body surface area (BSA) coverage of lesions and erosions.  In the clinical trial, SD-101 application resulted in complete closure of 88% of target chronic lesions within one month, in addition to a 57% reduction in BSA coverage of lesions and erosions after 3 months of daily treatment.   SD-101 was well tolerated by the children, with daily administration up to 3 months.

About Scioderm

Scioderm is a privately held, clinical-stage pharmaceutical company focused on developing topical products to address critical medical needs in the treatment of chronic skin diseases.  Additional information about Scioderm can be found at www.sderm.com

Company Contact:

Robert Coull
Chief Operating Officer
robert.coull@sderm.com  
(917) 345-2504   

Forward-Looking Statements 

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks.  Actual results may differ materially from those projected.  These forward-looking statements represent our judgment as of the date of the release.  Scioderm disclaims any intent or obligation to update these forward-looking statements.

Media Contact: Robert Coull , Scioderm, 917-345-2504, robert.coull@sderm.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE Scioderm
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Sanofi Pasteur Presents Pediatric Data on Investigational Quadrivalent Influenza Vaccine
2. Data from Study of Elderly Depressed Patients are Reported for Investigational Compound Lu AA21004 on Symptoms of Major Depressive Disorder (MDD)
3. Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
4. Results of Phase II Study of Boehringer Ingelheims Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference
5. Lilly Diabetes Presents Phase II Blood Pressure and Heart Rate Data on Investigational GLP-1 Analog Candidate, Dulaglutide, in Patients with Type 2 Diabetes at the 27th American Society of Hypertension Scientific Meeting
6. Lilly and Boehringer Ingelheim Present Data at the 72nd American Diabetes Association Scientific Sessions® from Phase II Studies Comparing Investigational Novel Basal Insulin to Insulin Glargine
7. Abbott Presents Results of Clinical Studies Evaluating Its Investigational Treatment for Advanced Parkinsons Disease
8. Results For Phase 2b Trial Of Unique Investigational Cell-Based Therapy In Venous Leg Ulcers Published In The Lancet
9. Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab
10. Clinical Study With Investigational Cream Aims To Help Women Who Experience Painful Sex
11. Omeros Files Investigational New Drug Application for Lead Compound in PDE10 Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/7/2017)... 2017  Diplomat Specialty Infusion Group, a brand of Diplomat Pharmacy, ... Iowa location. The ... features an ISO 7 cleanroom—the standard needed to compound intravenous (IV) ... level of pollutants. "Our new ... better serve our Iowa patients," said ...
(Date:6/1/2017)... , June 1, 2017 Nutriceutical Holdings ... Veterinarian Recommended Solutions (VRS), and KD Pharma Group have ... Nutriceutical Holdings by KD Pharma Group. KD Pharma Group ... the option to acquire the entire company. ... KD. They are committed to growing the NH companies ...
(Date:5/26/2017)... 26, 2017  Endo International plc (NASDAQ: ENDP ... CEO, will represent the Company in a fireside chat at ... Tuesday, June 13, 2017 at 10:40 a.m. PT / 1:40 ... in Rancho Palos Verdes, CA. ... will be available on the Company,s website at http://www.endo.com/investors/overview ...
Breaking Medicine Technology:
(Date:6/24/2017)... , ... June 24, 2017 , ... The weather is ... time outdoors. Home and business owners should be aware that the summer months provide ... In fact, mechanical locks and keys can be negatively affected from direct exposure to ...
(Date:6/23/2017)... ... June 23, 2017 , ... The Rhode ... of Care Management Alerts and Dashboards, an innovative new service enabling healthcare providers ... RIQI’s Care Management Alerts and Dashboards provide near real-time data about patients admitted ...
(Date:6/23/2017)... ... June 23, 2017 , ... By scoring 100% for fiscal management and accountability, ... premier online charity evaluator, Charity Navigator, validating ANRF's work as a top charity in ... by Charity Navigator and earns ANRF a spot on their “ 10 Charities Worth ...
(Date:6/23/2017)... ... ... Studies show evidence that carotenoids and antioxidants derived either from the diet ... , But how often do ophthalmologists and optometrists in Sweden recommend the use of ... with early symptoms of AMD? A study published recently in Dove Medical ...
(Date:6/23/2017)... ... June 23, 2017 , ... Dr. Ran Y. Rubinstein ... recently begun offering three new minimally invasive procedures to patients who want a ... downtime, Dr. Rubinstein is excited to bring microneedling, microneedling facials, and platelet rich ...
Breaking Medicine News(10 mins):