NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced dosing of the first patient in its Phase 2 clinical study of NGX-1998, a liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN).
The target profile for NGX-1998 is to provide safety, efficacy and tolerability that is at least comparable to Qutenza® (capsaicin) 8% patch with a significantly shorter application time.
The Phase 2, adaptive-design, clinical study will be conducted in two stages. The first stage is designed to determine the shortest tolerable anesthetic pretreatment regimen. The second stage will evaluate two NGX-1998 dose concentrations using the pretreatment regimens determined during stage 1. The objective is to select the appropriate concentration of NGX-1998 and pretreatment period for further evaluation in a Phase 3 clinical program. Up to 200 PHN patients are targeted for enrollment.
Jeffrey Tobias, MD Executive Vice President for Research and Development and Chief Medical Officer commented, "We are very pleased to have initiated our Phase 2 study of NGX-1998. Previous Phase 1 studies have suggested that NGX-1998 may deliver an effective dose of capsaicin in as little as five minutes. This study will now explore the shortest tolerable pretreatment regimen as well as provide preliminary efficacy and safety data of two concentrations of NGX-1998 in patients with PHN. These data will help us select the optimal dose of NGX-1998 and shortest overall treatment regimen. NGX-1998 is an important product candidate for the long-term growth of our neuropathic pain franchise and we are happy to have this clinical trial underway."