Tioga Pharmaceuticals is planning to conduct a phase 2 trial of its selective kappa-opioid receptor agonist, asimadoline, for the treatment of associated with atopic pruritus.

• Asimadoline has been administered to over 1,500 subjects in a variety of clinical trials and is well-tolerated. As a highly selective kappa-opioid receptor agonist, asimadoline does not produce mu-opioid like side effects.
• The kappa agonist nalfurafine (Remitch®) is marketed in Japan for the treatment of chronic pruritus in end stage renal disease (ESRD). The efficacy of nalfurafine provides clinical proof of concept for the kappa agonist mechanism for the treatment of pruritus.
• Asimadoline will be studied initially in pruritus in atopic dermatitis (AD). In addition to providing relief of the chronic itch associated with this condition, breaking the “itch-scratch cycle” may have a disease-modifying action. Other indications may be pursued in parallel with the phase 3 AD program. There are no safe, effective and novel prescription medicines approved to treat pruritus.
• A pivotal role for endogenous opioids has been postulated in chronic pruritus. A decreased kappa drive coupled with an increased mu-opioid drive is associated with itch in ESRD, AD and cholestatic disease.
• Due to its mechanism of action, which replaces lost endogenous kappa ligand and targets a final pathway in itch signaling, asimadoline has the potential to treat pruritus associated with several diseases, including many other skin diseases (e.g. psoriasis) and systemic diseases (e.g. ESRD, cholestatic disease, hyperthyroidism).
• The lifecycle strategy for asimadoline includes novel oral and topical formulations (for dermatological indications) and combination therapeutic approaches to offer a holistic solution to the various indications of focus.