Processa Pharmaceuticals Announces Poster Presentation of Adaptive Phase 2/3 PCS499 Study in FSGS at ASN Kidney Week 2025

Rhea-AI Summary

Processa Pharmaceuticals (Nasdaq: PCSA) announced that its abstract, “Adaptive Phase 2/3 Study for PCS499 in Patients with Focal Segmental Glomerulosclerosis (FSGS)”, was accepted for poster presentation at ASN Kidney Week 2025 in Houston, Nov 5–9, 2025.

The poster is scheduled in the session “Glomerular Clinical Trials: From Data to Impact” on Nov 7, 2025, 10:00–12:00 CT (board FR-PO0829). PCS499 is an analog of a pentoxifylline metabolite that has shown a favorable safety profile versus PTX, potentially allowing higher dosing for greater benefit in rare kidney diseases like FSGS. Processa will discuss an adaptive Phase 2/3 design with the FDA later in 2025 to optimize dosing and accelerate development.

Insights

Clinical Development Expert

Poster acceptance and an adaptive Phase 2/3 design discussion with regulators marks meaningful clinical progress for PCS499.

Processa secured a poster slot at ASN Kidney Week on November 7, 2025, presenting an adaptive Phase 2/3 study for PCS499, an analog of a pentoxifylline metabolite. The program reports a favorable safety profile versus pentoxifylline, enabling higher dosing and a potential efficacy advantage in focal segmental glomerulosclerosis (FSGS).

The upcoming FDA discussion and the adaptive design matter because they target faster dose optimization and regulatory clarity. Risks remain: the announcement contains no efficacy outcomes, and safety claims are stated without supporting data in this release, so regulatory feedback and the poster details will determine true impact.

Watch for the poster content on November 7, 2025, any FDA meeting outcomes later this year, and explicit safety and efficacy readouts from the Phase 2/3 protocol or interim analyses within the next 6–18 months.

VERO BEACH, Fla., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies and innovative treatments for rare diseases, today announced that its abstract, “Adaptive Phase 2/3 Study for PCS499 (499) in Patients with Focal Segmental Glomerulosclerosis (FSGS)”, has been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2025, taking place November 5–9, 2025, in Houston, Texas.

The poster will be presented as part of the session “Glomerular Clinical Trials: From Data to Impact” on Friday, November 7, 2025, from 10:00 a.m. to 12:00 p.m. Central Time. The poster board number is FR-PO0829.

PCS499 is an analog of a metabolite of pentoxifylline (PTX). PTX has been shown to decrease proteinuria in clinical studies with CKD patients but the dose limiting side effects limits its use. PCS499 has demonstrated a favorable safety profile over PTX allowing for a higher dose and potentially greater therapeutic benefit in rare kidney diseases such as FSGS, a serious condition with limited treatment options. The adaptive Phase 2/3 design that Processa will be discussing with FDA later this year and presenting at ASN aims to optimize dosing and accelerate the path toward regulatory approval.

“We are honored to present our PCS499 program at ASN Kidney Week, the premier forum for advancing kidney disease research and patient care,” said David Young, Pharm.D., Ph.D., President of Research and Development at Processa Pharmaceuticals. “This adaptive Phase 2/3 study represents a critical step in addressing the urgent need for safer, more effective therapies for patients with FSGS. We believe PCS499 has the potential to significantly improve patient outcomes in this underserved population.”

About FSGS

Focal Segmental Glomerulosclerosis is a rare, progressive kidney disease characterized by scarring in the kidney’s filtering units, often leading to end-stage renal disease. There are currently no FDA-approved therapies specifically indicated for FSGS, underscoring the urgent need for new treatment options.

About Processa Pharmaceuticals, Inc.

Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value

For more information, visit our website at www.processapharma.com.

Forward-Looking Statements

This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

Company Contact:

Patrick Lin
(925) 683-3218
plin@processapharma.com

Investor Relations:

Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
PCSA@redchip.com

FAQ

When will Processa (PCSA) present the PCS499 poster at ASN Kidney Week 2025?

The PCS499 poster is scheduled for Nov 7, 2025, 10:00–12:00 CT during the session “Glomerular Clinical Trials: From Data to Impact.”

What is the poster board number for Processa's PCS499 presentation at ASN Kidney Week (PCSA)?

The poster board number is FR-PO0829.

What is PCS499 and how does it differ from pentoxifylline in Processa's ASN presentation (PCSA)?

PCS499 is an analog of a pentoxifylline metabolite; it has demonstrated a more favorable safety profile than PTX, potentially permitting higher dose use.

What is the goal of the adaptive Phase 2/3 PCS499 study discussed by Processa (PCSA)?

The adaptive Phase 2/3 design aims to optimize dosing and accelerate the path toward regulatory approval for FSGS.

Will Processa (PCSA) meet the FDA about the PCS499 trial design in 2025?

Processa plans to discuss the adaptive Phase 2/3 design with the FDA later in 2025 according to the announcement.

How might PCS499 affect patients with FSGS according to Processa's announcement (PCSA)?

Processa says PCS499 could allow higher dosing with a favorable safety profile, potentially offering greater therapeutic benefit for patients with FSGS.