Core Viewpoint - Processa Pharmaceuticals has completed the enrollment and dosing of 20 patients for an interim analysis in its Phase 2 clinical study evaluating NGC-Cap, a combination treatment for advanced or metastatic breast cancer, with results expected in Q1 2026 [2][3]. Study Design and Patient Characteristics - The Phase 2 study is randomized and FDA-recommended, comparing NGC-Cap (Arm A) with capecitabine monotherapy (Mono-Cap, Arm C) in patients who have undergone at least one prior cancer treatment, with a median of two to three prior regimens [4]. - NGC-Cap consists of PCS6422 administered one day prior to capecitabine, followed by capecitabine at 150 mg twice daily for seven days on and seven days off, while the Mono-Cap arm consists of capecitabine at 1,000 mg/m² twice daily for 14 days followed by seven days off [5]. Mechanism of Action - PCS6422 is designed to enhance the metabolism of capecitabine by increasing the formation of cancer-killing metabolites (anabolites) and decreasing the formation of side effect-associated metabolites (catabolites) [6]. Interim Analysis Objectives - The interim analysis aims to compare safety and preliminary efficacy outcomes between NGC-Cap and Mono-Cap, with key objectives including evaluating early clinical benefit signals and guiding potential dose optimization and study design adjustments [7][10]. About NGC-Cap - NGC-Cap is Processa's lead oncology asset, aimed at improving the therapeutic index of capecitabine-based therapy by increasing systemic exposure to active metabolites while reducing toxic metabolites [8]. Company Overview - Processa Pharmaceuticals is focused on developing Next Generation Cancer drugs that modify existing FDA-approved therapies to improve safety and efficacy, utilizing a Regulatory Science Approach to enhance tolerability for cancer patients [9].

Core Insights - Processa Pharmaceuticals is advancing its Phase 2 study of NGC-Cap, a combination of PCS6422 and capecitabine, showing promising preliminary results in increasing cancer-killing metabolite exposure while maintaining safety compared to standard capecitabine therapy [1][2][3]. Clinical Update - The ongoing Phase 2 study targets patients with advanced or metastatic breast cancer, with preliminary data from the first 16 of 19 enrolled patients indicating significant increases in exposure to capecitabine metabolites without heightened side effects [2][3][4]. - The full interim analysis, expected in early 2026, will provide comprehensive efficacy and safety data from the first 20 patients [4][11]. Safety and Efficacy Observations - Initial findings show that patients receiving NGC-Cap (150 mg twice daily) experienced higher exposure to active cancer-killing metabolites compared to those on standard Mono-Cap (1,000 mg/m² twice daily) [6]. - Although a greater proportion of patients on NGC-Cap reported side effects related to the active metabolites, the severity of these side effects was comparable to those on Mono-Cap, indicating manageable toxicity levels [7][9]. Metabolite Analysis - Patients on NGC-Cap exhibited up to ten times lower exposure to FBAL, a catabolite associated with side effects like hand-foot syndrome (HFS), compared to those on Mono-Cap [8]. - The incidence of HFS was similar between treatment groups, but symptoms were milder (Grade 1) in the NGC-Cap group compared to more severe symptoms (up to Grade 2) in the Mono-Cap group [9][10]. Strategic Importance - The NGC-Cap program is viewed as a key value driver for Processa, with the potential to improve therapeutic outcomes for patients with advanced or metastatic breast cancer by balancing efficacy and tolerability [5][12].