#USA #Paradigm Therapeutics #Eshelman Ventures #Mt Pleasant #SD-101

Paradigm Therapeutics Receives Additional Funding

Paradigm Therapeutics, Inc., a notable biopharmaceutical firm, has secured an additional investment of $12.6 million from Eshelman Ventures, LLC, pushing its total financing for 2025 to approximately $25.1 million. This funding is pivotal for accelerating the global development and registration of SD-101, a topical therapy designed to aid patients suffering from Epidermolysis Bullosa (EB).

SD-101 and Its Importance

SD-101 represents a groundbreaking therapeutic option as the first topical treatment targeting the management of skin lesions and wounds across all EB subtypes. Epidermolysis Bullosa is a rare genetic disorder that causes the skin to be exceedingly fragile, leading to severe blistering and open wounds. Traditionally, patients have faced a lack of effective treatment options for the whole body, which adds to the disease's daunting challenges.

Dr. Robert Ryan, CEO of Paradigm Therapeutics, expressed optimism about the potential of SD-101, stating that the new funding will greatly facilitate the necessary activities to accelerate its commercial launch. The company plans to work closely with global regulatory authorities to introduce this innovative treatment to patients worldwide.

Significance of the Investment

The investment from Eshelman Ventures not only underscores the confidence backers have in SD-101 but also emphasizes the urgent need for treatment options for those affected by EB across its various forms. Dr. Ryan revealed that clinical trials conducted in both the U.S. and Europe have shown substantial benefits of SD-101, supporting the urgency for its regulatory progression.

This funding will specifically boost manufacturing and regulatory efforts, ensuring that SD-101 can reach the market efficiently, thereby addressing a pressing medical need. It aims to significantly reduce the incidence of skin infections, which are common among EB patients and lead to severe morbidity and mortality.

Clinical Trial Results

The clinical trials for SD-101 have included over 217 patients, exhibiting promising outcomes, particularly in terms of wound healing and overall skin integrity. The treated participants comprised children and adults afflicted with various subtypes of EB, including Simple EB and recessive dystrophic EB. Participants received daily applications of SD-101 over a period of three months, and results demonstrated not only improvement in wound closure but also an excellent safety profile, supporting long-term use of the product.

The FDA has recognized SD-101 as a breakthrough therapy, highlighting the treatment’s potential to vastly improve the lives of those affected by EB. Additionally, it has received orphan drug designation both in the U.S. and European Commission, which can facilitate faster regulatory review and benefits as the product moves toward market introduction.

Conclusion

Paradigm Therapeutics is dedicated to transforming the treatment landscape for Epidermolysis Bullosa with SD-101. With the additional support from Eshelman Ventures, the firm is poised to expedite its regulatory journey, thereby aiming to alleviate the suffering of patients afflicted with this debilitating condition. The company's commitment to delivering a safe and effective therapy underscores the importance of addressing unmet medical needs in rare diseases like EB.

For more information about Paradigm Therapeutics and SD-101, interested parties can contact Dr. Robert Ryan at Paradigm Therapeutics. The journey towards bringing SD-101 to the global market is a significant step not just for the company but also for the countless individuals living with Epidermolysis Bullosa who await innovative treatment options.