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First Topical Therapy Developed to Treat the Wounds and Lesions on the Entire Skin Surface Across All EB Subtypes
Funding to be Used to Accelerate Activities Associated with Increasing Manufacturing Development of SD-101 and Commercial Launch of the SD-101 Program Globally.
MT PLEASANT, S.C., June 18, 2025 /PRNewswire/ -- Paradigm Therapeutics, Inc., a biopharmaceutical company, announces an additional investment by Eshelman Ventures, LLC of $12.6 million, bringing the total investment in 2025 for Paradigm Therapeutics to $25.1 Million. Dr. Eshelman will continue to serve as a strategic advisor for Paradigm. SD-101 is being developed as a topical whole-body treatment for all subtypes of Epidermolysis Bullosa (EB) patients. The additional investment will be used to accelerate activities associated with the anticipated commercial launch of the SD-101 program globally, including manufacturing and regulatory activities.
"The opportunity to bring in additional investment for the SD-101 program will allow Paradigm to accelerate activities as we work towards bringing SD-101 to patients living with Epidermolysis Bullosa globally," said Robert Ryan, Ph.D., Chief Executive Officer of Paradigm Therapeutics. "Paradigm's goal is to work with regulators globally to address the need for a whole skin surface treatment option for individuals living with Epidermolysis Bullosa, regardless of their subtype. Paradigm believes its clinical data to date supports and demonstrates the ability of SD-101 to help patients across the range of disease of Epidermolysis Bullosa and we look forward to continuing to work towards its registration while working in parallel with potential partners."
Dr. Ryan further added, "Epidermolysis Bullosa is a devastating disease. We believe the clinical data emerging from the US and European study sites 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 EB patients, who do not have any whole body treatment alternatives. Clinical data also demonstrate that SD-101 has a favorable safety profile when used long term. Importantly, whole-body therapy with SD-101 reduces the incidence of skin infections which are a leading cause of morbidity and mortality in EB patients."
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
SD-101 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 measurements were assessment of target wound closure, in addition to secondary measurements including reduction in whole-body surface area (BSA) coverage of blisters and wounds and demonstration of an excellent safety profile supporting the long-term use of the product for chronic therapy.
SD-101 was the first EB treatment to receive the FDA's Breakthrough Therapy designation. SD-101 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 , 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 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
