Topical Therapeutic for Ocular Trauma

This Sequential Phase II SBIR proposal supports the completion of additional preclinical and analytical development work that is required by the FDA to qualify the SDP-4 eye drop's safety profile for Phase 3 clinical trial readiness.   Three Technical Objectives have been identified to accomplish this work: (1) perform precommercial safety testing of SDP-4; (2) develop an antibody-based bioanalytical method for SDP-4 detection in human plasma; and (3) develop a stability indicating method for SDP-4.   These studies have been designed to be completed by the end of a 6-month contract period and position the SDP-4 technology at a late TRL-6 stage of development.  The successful completion of this work will expand the safety profile of SDP-4 by evaluating the drug’s distribution profile within the ocular space, and further, to extend safety studies to the pregnant and fetal population.  In addition, the development of a highly sensitive, antibody-based detection method for SDP-4 in human blood will be used to demonstrate the lack of systemic SDP-4 delivery from topical ocular dosing, and hence provide justification to not perform additional, multi-year carcinogenicity testing.  Lastly, this work will establish and qualify a stability indicating method for SDP-4 degradation which will clarify shelf life, isolated SDP-4 degradation products, and characterize these as required by the FDA prior to commercialization. Most importantly, this work will enable the SDP-4 eye drop drug product to undergo Phase 3 clinical trials.    Background: Silk Technologies, Ltd. (DBA SilkTech Biopharmaceuticals) specializes in the isolation and manufacture of patented silk-derived proteins (SDP) for therapeutic applications. The company’s lead biotherapeutic candidate, SDP-4, has been formulated and GMP manufactured into an eye drop product for use in treating ocular trauma and disease conditions.  SDP-4 has been previously shown to exhibit anti-inflammatory and pro-regenerative effects within both in vitro and in vivo ocular surface wound healing models.   Pre-clinical studies have been demonstrated that SDP-4 has an exceptional safety profile and can be consistently produced at scaled volumes.  This work has culminated in the submission of an Investigational New Drug (IND) application to the FDA, and a recent exploratory Phase 2B human clinical trial that demonstrated the drug candidate’s potential efficacy in treating ocular surface disease (dry eye) in a multi-clinical site, dose-ranging, placebo-controlled study.