First Topical Therapy Developed to Treat the Wounds and Lesions on the Entire Skin Surface Across All EB Subtypes
Funding to be Used for Completion of All Activities to Support Planned NDA Submission in the Second Half of 2025, Along with Plans for Commercialization in the U.S.
MT PLEASANT, S.C., May 6, 2025 /PRNewswire/ -- Paradigm Therapeutics, Inc., a biopharmaceutical company, announces a $12.5 Million investment by Eshelman Ventures, LLC and appointment of Dr. Eshelman as a strategic advisor for Paradigm. SD-101 (Zorblisa) is being developed as a topical whole-body treatment for all subtypes of Epidermolysis Bullosa (EB) patients. Funds will be used to complete all activities to support an NDA submission in the later part of 2025.
"We are excited about the opportunity to complete the development activities for SD-101 (Zorblisa) and to move a path forward towards registration of this therapy for patients with all EB subtypes," said Robert Ryan., Ph.D., Chief Executive Officer of Paradigm Therapeutics. "There is a tremendous need for novel whole skin surface treatment options for treating the debilitating skin effects across all patients with Epidermolysis Bullosa. The Paradigm Therapeutics team will be working passionately to provide patients with a new therapeutic alternative in this disease with limited whole-body treatment options. Paradigm's goal is to provide this therapy to patients on a global basis and is working in parallel with potential partners to work towards this goal as quickly as possible."
Dr. Ryan added, "Epidermolysis Bullosa is a devastating disease. We believe the clinical data show beneficial effects of the use of SD-101 across the range of EB patients, and strongly support progression towards registration. Results from the completed Phase II and Phase III trials indicate that SD-101 demonstrated a broad benefit with whole body treatment of the lesions and wounds on the entire skin surface in pediatric and adult patients across all EB patients, who have limited whole body treatment alternatives. Results also demonstrated that SD-101 has a favorable safety profile when used long term."
"Eshelman Ventures is honored to invest in Paradigm Therapeutics and play a pivotal role in accelerating the development of SD-101 as a transformative treatment for Epidermolysis Bullosa," said Dr. Eshelman, founder of Eshelman Ventures. "As an investor and strategic advisor, I am deeply committed to working closely with this exceptional team as we work tirelessly to bring this innovative therapy to patients in need. The urgency of addressing the challenges faced by EB patients is what drives us; our goal is to provide an improved quality of life in this area of unmet need. Together, we will strive to revolutionize treatment options and make a meaningful impact on the lives of those affected by this debilitating disease."
About Epidermolysis Bullosa (EB)
Epidermolysis Bullosa is a rare, devastating genetic disorder causing very fragile skin that leads to severe skin blistering and open wounds often beginning at birth. There are no approved therapies that were developed to treat the entire skin surface of patients across all subtypes of EB patients, including wounds and lesional skin, which affects children and adults throughout their lifetimes. EB is a chronic disease, potentially disfiguring, and in some cases fatal. There are many genetic and symptomatic variations of EB, but all forms share the common symptom of fragile skin that blisters and tears, sometimes from the slightest friction or trauma.
About SD-101 (Zorblisa)
SD-101 (Zorblisa) is a topical cream that has demonstrated potential to provide improvement in treating the severe skin disruptions seen in patients across all EB subtypes. Phase II and Phase III studies were conducted in children and adults with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB. A total of 217 EB patients were included in these studies. SD-101 was applied topically over the entire body daily in adults and children as young as 21 days old for a period of three months. The primary outcome measurement was assessment of target wound closure, in addition to secondary measurements including reduction in body surface area (BSA) coverage of blisters and wounds.
SD-101 (Zorblisa) was the first EB treatment to receive the FDA's Breakthrough Therapy designation. SD-101 (Zorblisa) received Rare Pediatric Disease designation from the U.S. Food and Drug Administration (FDA) covering the broad treatment of EB. In addition to the Rare Pediatric Disease designation, SD-101 was granted Orphan Drug designation from the FDA and the European Commission (EC). Upon approval, Paradigm will be eligible to receive a Priority Review Voucher (PRV).
About Paradigm Therapeutics, Inc.
Paradigm Therapeutics, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing innovative therapies to address critical medical needs in the treatment of rare diseases. Paradigm's main focus is the treatment of Epidermolysis Bullosa (EB). SD-101 (Zorblisa), its leading therapy for the treatment of skin effects in patients with Epidermolysis Bullosa, has completed Phase II and Phase III clinical trials. SD-101 (Zorblisa) is a topical cream that requires no special handling and can be stored at room temperature and has demonstrated potential to provide improvement in treating the severe skin effects seen in patients across all EB subtypes.
Forward Looking Statement
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. Paradigm disclaims any intent or obligation to update these forward-looking statements.
Company Contact
Dr. Robert Ryan
Chief Executive Officer
rryan@paradigmtherapeutics.com
(919)-274-0703
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