Processa Pharmaceuticals reported that its first‑in‑human Phase 2 study of NGC‑Cap—combining the DPD inhibitor PCS6422 with capecitabine—has produced encouraging preliminary data from 16 of 19 patients with metastatic breast cancer. The interim analysis shows that NGC‑Cap increases exposure to the active capecitabine metabolite 5‑fluorouracil (5‑FU) while maintaining side‑effect severity comparable to standard capecitabine monotherapy. Importantly, the combination reduces the toxic catabolite FBAL by up to ten‑fold, a metabolite linked to hand‑foot syndrome, the most common dose‑limiting toxicity of capecitabine.
The pharmacologic advantage of NGC‑Cap lies in its irreversible inhibition of dihydropyrimidine dehydrogenase (DPD), the enzyme that converts 5‑FU into catabolites that cause adverse effects. By blocking DPD, PCS6422 preserves more 5‑FU for tumor killing while limiting the formation of FBAL, thereby potentially improving both efficacy and tolerability. The data suggest a higher therapeutic index for capecitabine, a key goal of Processa’s Next‑Generation Cancer platform and a differentiator in the crowded metastatic breast cancer market.
Management emphasized the clinical significance of the findings. Dr. David Young, President of Research and Development, said the results “continue to validate the central premise of our Next Generation Cancer strategy” and that the exposure profile “aligns closely with our pharmacologic expectations.” CEO George Ng added that the data “demonstrate a differentiated pharmacologic profile that could meaningfully improve the therapeutic index of capecitabine‑based therapy.” The company plans to enroll the final patient and release a full interim analysis in early 2026, with enrollment completion targeted for the end of the first quarter of 2026.
The positive data have already generated a strong market reaction, with analysts noting that the combination’s ability to increase active metabolite exposure while reducing a key toxicity marker is a rare achievement in oncology drug development. Investors view the milestone as a de‑risking event that could accelerate the drug’s path to regulatory approval and commercial launch, potentially expanding Processa’s addressable market in metastatic breast cancer and beyond.
The company’s reverse stock split, effective December 16, 2025, was a routine action to meet exchange listing requirements and does not affect the clinical significance of the data. Processa’s cash burn remains a consideration for long‑term investors, but the Phase 2 results provide a critical data point that could influence future funding and partnership opportunities.
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