Serpin Pharma, LLC

A Novel LRP1 Agonist, SP16, as a Therapeutic Treatment in Preventing Chemotherapy-induced Peripheral Neuropathy - Abstract Chemotherapy-induced Peripheral Neuropathy (CIPN) Is a Significant Clinical Challenge Affecting Over Half of the 28 Million Cancer Survivors. There Are No Approved Therapies to Prevent Cipn, and Off-label Use of Drugs (e.g., Duloxetine) Are Marginally Effective While Associated With Adverse Side Effects. Taxanes Are Among the Most Neurotoxic Agents, Resulting in Dose Limiting Cipn That Can Impact Cancer Survival. Chronic Pain and Potentially Permanent Nerve Damage Have a Long-term Impact on the Quality of Life for Over 30% of Cancer Survivors. Serpin Pharma’s SP16 Is a Safe, First-in-class, Anti-inflammatory Drug With Regenerative and Analgesic Functions After Peripheral Nerve Injury. SP16 Activates LRP1, a Key Signaling Receptor Regulating Several Factors Contributing to Peripheral Neuropathy. Through SP16’S Unique Mechanism, Damaging Inflammation Is Mitigated, the Immune Response Is Rebalanced, and Tissues Are Protected Against Further Damage, Creating an Entirely New Class of Anti-inflammatory Drugs Void of Immunosuppressive and Its Associated Harmful Side Effects. SP16 Has Demonstrated Direct Analgesic and Regenerative Effects and Thus Provides a Unique Strategy to Address the Root Cause of Cipn. Our Key Proof-of-principle Data From the Phase 1 Studies Demonstrate That LRP1 Is a Potential Therapeutic Target in Cipn, and Treatment With the LRP1 Agonist, SP16, Alleviates Sensory Neuropathy in Translational Models of Taxane-induced Peripheral Neuropathy. Importantly, SP16 Does Not Interfere With the Anti- Cancer Activity of Several Classes of Chemotherapy, Including Taxane Agents, a Critical Safeguard Control for Using SP16 in Conjunction With Chemotherapy. This Project Aims to Develop SP16 as a Preventative Treatment for Chemotherapy-induced Peripheral Neuropathy, With the Initial Target Population Being Breast Cancer Patients Receiving Taxane-based Agents. Pre-clinical Studies Are Planned to Confirm the Appropriate Dose Range for the Clinical Trial and Complete the Remaining Ind-enabling Studies. an Ind (investigational New Drug) Packet Will Be Submitted for Fda Approval. the Safety and Tolerability of SP16 Will Be Evaluated in a Phase 1B Escalating Dose Trial in Breast Cancer Patients Treated With Paclitaxel. SP16 Will Be Administered With the Standard of Care (SOC) Once Per Chemotherapy Treatment Cycle. the Primary Endpoints of This Study Will Focus on the Safety of SP16 in Breast Cancer Patients With Exploratory Outcomes Aimed at Preventing Cipn. These Outcomes Will Help Define the Dosing and Endpoints for the Future Phase 2 Clinical Study Demonstrating the Efficacy of SP16. After the Phase 2 Clinical Trial Is Completed, Serpin Pharma Plans to License SP16 to a Pharmaceutical Partner for Phase 3 Studies, Drug Approval, and Commercialization. SP16 Is a Complete, Therapeutic Solution to Address an Acute, Unmet Clinical Need Affecting a Significant Cancer Patient Population.