Novel long-acting non-opioid therapeutic for treating diabetic peripheral neuropathic pain

Purpose and goal

The project´s aim is to develop AP-1001, a new long-acting and non-opioid treatment for painful diabetic neuropathy. AP-1001 will reduce pain signals in the peripheral nervous system and thereby avoid many of the side effects that current treatments can cause. The goal is to develop an optimized formulation for injection once a week and demonstrate the efficacy and safety of the treatment in relevant preclinical models.

Expected effects and result

The project is expected to result in an optimized AP-1001 candidate and formulation with a long duration of action, as well as preclinical data demonstrating efficacy, safety and appropriate dosing. A new animal model for neuropathic pain will also be developed and validated. The results will provide a basis for continued development towards clinical studies and, in the long term, contribute to safer and more effective treatment for patients with painful diabetic neuropathy.

Planned approach and implementation

The project is being implemented by Akasi Pharma, NovoArc and IVRS in five work packages. Akasi develops and selects the drug candidate AP-1001. NovoArc develops a long-acting lipid-based formulation. IVRS develops and validates an animal model for neuropathic pain and conducts efficacy studies. Pharmacokinetic and pharmacodynamic studies are then conducted. The project is continuously monitored through joint project management, milestones and decision points.