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news.SCRA Technology Ventures’ SC Launch Portfolio Company FirstString Research has recently completed a multicenter, randomized clinical trial where a novel peptide has been found to heal chronic venous leg ulcers twice as quickly as the current standard of care. FirstString’s product, Granexin gel, which contains the peptide, ACT1, possesses anti-inflammatory and regenerative properties.
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The results of this Phase 2 study, investigating the efficacy and safety of this topical ACT1 formulation when combined with standard care in treatment of chronic venous leg ulcers, were recently published in the prestigious Journal of Investigative Dermatology. The study findings have been released and will be available in print in the upcoming issue.
FirstString Research, a Charleston-based clinical stage biotech company, focuses on the development and commercialization of therapeutics for scar prevention and tissue regeneration. ACT1 is synthetic peptide modeled after a portion of the intercellular communicating protein connexin43, and works by targeting connexin43’s binding partners and modulating intercellular communication and cell-to-cell contact.
Venous leg ulcers develop as a result of impaired circulation in the legs leading to venous hypertension and vessel damage. The tissues break down from the inside out resulting in ulcer formation. It is a particular problem in the elderly and can lead to painful wounds that remain refractory to current treatments that often recur even after closure. In most people, such an injury heals without difficulty within a week or two. However, when there is an underlying problem the skin does not heal and the area of breakdown can increase in size resulting in a chronic ulcer and the need for specialized care.
"Chronic wounds, like venous leg ulcers, remain stalled in the initial inflammatory phase of wound healing and fail to heal. What is broadly lacking, are therapeutics that address the underlying pathophysiology associated with the impaired wound healing response in these wounds. " said Dr. Christina Grek, Director of Translational Research at FirstString.
The clinical trial included participants with chronic ulcers that had remained refractory to standard of care for an average of 17 months. At 12 weeks, GranexinTM treatment was associated with a 43% increase in incidence of complete ulcer closure as compared to control treatment alone. This translates to a significant improvement in terms of healing prognosis. GraenxinTM was also safe and well-tolerated.
"ACT1 represents a first-in-class drug that targets the connexin signaling pathways. This publication denotes the first peer-reviewed report of a randomized, multi-center, controlled, clinical trial demonstrating connexins as effective biological targets for wound healing." said Dr. Gautam Ghatnekar, CEO of FirstString.
"This represents a milestone for FirstString Research, and I am proud of our team for a great job on executing the Phase 2 clinical trial in venous leg ulcer patients."
"We are pleased that FirstString has successfully completed this Phase 2 study and will receive recognition in a respected publication," said SCRA CEO Bill Mahoney. "FirstString continues to make strides in the wound healing technology market and we are delighted that this significant technology company calls South Carolina home."