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, Inc. (NASDAQ:PCSA) stock surged by 130.95% to $6.94 following a clinical update on its Phase 2 study of NGC-Cap, a combination treatment for advanced or metastatic breast cancer [7]. Clinical Study Findings - The first 16 of 19 patients in the Phase 2 study showed that NGC-Cap significantly increases exposure to capecitabine metabolites without increasing side effects compared to standard Mono-Cap therapy [2]. - Patients were randomized to receive either NGC-Cap (150 mg twice daily) or standard-dose Mono-Cap (1,000 mg/m² twice daily), with preliminary findings suggesting NGC-Cap allows for greater exposure to effective cancer-killing components while avoiding increased severity of side effects [3]. Safety and Side Effects - Although patients receiving NGC-Cap experienced a higher total number of side effects related to capecitabine metabolites, the severity of these side effects was similar between the two treatment groups, indicating that increased activity did not lead to more severe toxicity [4]. - Patients on NGC-Cap had substantially lower exposure to FBAL, a catabolite metabolite associated with side effects like hand-foot syndrome (HFS), with exposure being up to ten times less than that of Mono-Cap [5]. - The incidence of HFS was similar between treatment groups, but symptoms in the NGC-Cap group were mild (Grade 1), while those on Mono-Cap experienced more severe symptoms (up to Grade 2) [6]. Future Plans - Processa anticipates completing enrollment for the final patient in the 20-patient interim analysis of the Phase 2 safety and efficacy study by the end of Q1 2026 [7].