#USA #Epidermolysis Bullosa #Paradigm Therapeutics #Mt Pleasant #SD-101

Paradigm Therapeutics Receives Major Investment for SD-101 Development

Paradigm Therapeutics, Inc., a biopharmaceutical company, has recently announced a significant investment of $12.6 million from Eshelman Ventures, LLC. This brings the total investment received in 2025 to $25.1 million, aimed at accelerating the global development and regulatory processes of the company’s groundbreaking topical therapy, SD-101, intended for the treatment of Epidermolysis Bullosa (EB).

What is Epidermolysis Bullosa?

Epidermolysis Bullosa is a rare genetic condition characterized by extreme skin sensitivity, causing severe blistering and open wounds from birth, often leading to chronic pain and significant morbidity. This condition affects individuals across all age groups, primarily causing struggles with skin integrity, mobility, and overall quality of life. There are currently no approved treatments that cater to the entire skin surface of patients with various subtypes of EB, creating a urgent need for effective therapeutic solutions.

Paradigm’s Innovative Solution: SD-101

SD-101 is a topical cream formulated to address the widespread skin lesions and wounds associated with all subtypes of Epidermolysis Bullosa. Clinical trials have explored its efficacy on both pediatric and adult patients, with promising results indicating substantial improvements in skin condition. The investment from Eshelman Ventures will bolster the production scope and regulatory strategy for the anticipated global launch of SD-101.

Dr. Robert Ryan, CEO of Paradigm, emphasized the significance of this additional funding in expediting their mission to make SD-101 accessible to EB patients worldwide. "The potential for this additional investment is invaluable as it positions Paradigm to enhance our efforts to deliver a treatment option that addresses the needs of patients with Epidermolysis Bullosa, regardless of their specific subtype," he remarked.

Clinical Data and Regulatory Status

Extensive clinical data from phase II and phase III trials have showcased SD-101's positive impact on patients suffering from EB, demonstrating its capacity to effectively facilitate wound healing on the skin's entire surface. Notably, SD-101 has achieved 'Breakthrough Therapy' status from the FDA, recognizing its promise in addressing significant unmet medical need in the pediatric demographic. As a result, it also qualified for the Orphan Drug designation, further supporting its development and potential market entry.

Dr. Ryan also pointed out that the usage of SD-101 not only strives to improve skin health but also aims to reduce common skin infections associated with EB, which are a leading cause of morbidity and mortality among these patients.

The Future of Paradigm Therapeutics

The focus of Paradigm Therapeutics remains steadfast on innovating solutions for the treatment of rare diseases. As they move forward with SD-101, the company is dedicated to working collaboratively with regulatory authorities across the globe to ensure the effective launch and distribution of this vital treatment. By doing so, they hope to change the landscape of care for Epiderolysis Bullosa and improve the lives of countless patients affected by this debilitating condition.

In summary, the recent financial backing from Eshelman Ventures is a significant leap forward in Paradigm Therapeutics' journey to bring SD-101 to market, paving the way for a healthier future for those battling Epidermolysis Bullosa.