CAMBRIDGE, Mass.--(BUSINESS WIRE)--Strategic Science and Technologies LLC (SST) today announced the signing of an option agreement with one of the world's largest over-the-counter (OTC) healthcare companies. The partner has received an exclusive option to obtain U.S. commercial rights to SST's topical ibuprofen (SST-0225) upon its approval by the U.S. FDA. SST-0225 is a patented topical cream product candidate containing ibuprofen, which incorporates SST's KNOSIS™ delivery technology. It is currently in late-stage clinical development for the OTC treatment of acute pain. Financial terms were not disclosed.
"This transaction provides SST with a very strong commercial partner to bring this important product directly to individuals who suffer from acute pain," commented Eric T. Fossel, Ph.D., Scientific Founder and Chief Executive Officer of SST. "The partner's leadership in marketing and manufacturing high-quality healthcare products provides us with the widest distribution at an accessible price."
Locust Walk Partners served as exclusive transaction advisor, and Gunderson Dettmer served as legal counsel to SST.
SST-0225 is a patented topical cream formulation containing ibuprofen currently in advanced-stage clinical development for the treatment of acute pain. SST-0225 offers several potential advantages over the currently available oral non-steroidal anti-inflammatory drug (NSAID) products including (1) more targeted local delivery at required therapeutic levels, (2) reduced systemic exposure, thereby eliminating known adverse events, and (3) more rapid onset of action to achieve a more immediate therapeutic benefit.
In clinical trials evaluating SST-0225 in the treatment of acute pain from both osteoarthritis and ankle sprain, SST-0225 was demonstrated to be very safe and well-tolerated, offering the potential for pain relief within the first 24 hours following initial application. These early results support the potential for SST-0225 to be the first ever topical NSAID product available to patients in the over-the-counter (OTC) marketplace. The development strategy for SST-0225 is leveraging the 505(b)(2) approval pathway at FDA with the target of achieving registration as a topical OTC product.
SST's novel topical technology, KNOSIS™, is based on the pioneering work of its Scientific Founder Eric T. Fossel Ph.D., formerly in the Biochemistry, Biophysics and Radiology Departments at Harvard Medical School. Due to the skin's highly protective barrier, the stratum corneum, success with topical delivery approaches has been mostly limited to smaller, uncharged molecules. SST's proprietary delivery technology overcomes these historical challenges through at least two novel features. First, the KNOSIS formulation technology produces a hostile biophysical environment for the active pharmaceutical ingredient (API), increasing its free energy and creating a positive chemical potential which drives the API from the delivery vehicle into the tissue. Second, this novel formulation prevents the formation of hydrogen bonds between the API and the stratum corneum, which can inhibit the ability of the API to permeate into the tissue. These two complementary actions support SST's efforts to achieve the desired local therapeutic effect in the target tissue and, due to the minimal uptake of the drug into the bloodstream, greatly reduce or eliminate any known side effects associated with its systemic absorption.
Strategic Science and Technologies LLC (SST) is a clinical-stage biotechnology company developing first-in-class topical formulations of known pharmaceutical products. SST has been successful in delivering several highly-charged molecules across the skin in therapeutic areas including pain, dermatology, and men and women's sexual health. By working only with FDA-approved drugs, SST utilizes the 505(b)(2) regulatory pathway to accelerate the development of topical formulations and is advancing a portfolio of both over-the-counter (OTC) and prescription drug product candidates. SST remains privately funded by its original private investors, with a business strategy to partner its products with experienced pharmaceutical companies prior to initiation of the pivotal Phase 3 registration trials. www.strategicscience.com