Front Range Pharmaceuticals Announces FDA Clearance to Initiate Phase 2 Trial of FRP-003 in Long COVID

Randomized, double-blind, placebo-controlled study will evaluate two doses of FRP-003 in approximately 220 adults with Long COVID and persistent fatigue

DENVER--(BUSINESS WIRE)--Front Range Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for FRP-003, allowing the company to proceed with a Phase 2 clinical trial in adults with Long COVID. FDA notified the company in writing on September 30, 2026, that the study may proceed.

The multicenter, randomized, double-blind, placebo-controlled Phase 2 study will enroll approximately 220 adults aged 18 to 65 with Long COVID and persistent, clinically meaningful fatigue as the predominant symptom, accompanied by post-exertional malaise (PEM) and reduced daily functioning. Participants will be randomized 1:1:1 to one of two fixed doses of FRP-003 or matching placebo, taken by mouth twice daily for 56 days.

The primary endpoint is the change from baseline to Day 56 in fatigue severity, measured by the PROMIS® Fatigue Short Form 8a T-score. Secondary endpoints include the proportion of participants with a meaningful improvement in fatigue, and changes in sleep disturbance and anxiety. Exploratory endpoints include cognitive function, quality of life, daily functioning, and biomarkers of inflammation and immune regulation. The study is designed to provide approximately 90% power to detect a clinically meaningful difference from placebo on the primary endpoint. An independent Data Monitoring Committee will periodically review unblinded safety data during the study.

The Phase 2 study will be the first clinical trial conducted under the IND. FDA's Botanical Drug Development guidance recognizes that prior human experience with botanical products may be relevant to clinical development. The company's IND included prior clinical experience with FRP-003, together with supporting nonclinical, manufacturing and other information for the proposed study.

That prior experience includes a published randomized study in 31 participants with persistent post-COVID symptoms (Young et al.; NCT04828668) and a subsequent 12-week open-label study in 14 participants. No serious adverse events were reported in either study, although both studies were small and were not designed to establish the safety or efficacy of FRP-003. These studies helped inform the population, dosing, endpoints and safety monitoring for the Phase 2 study.

"FDA clearance of our IND marks an important transition for FRP-003 into rigorous, controlled clinical development," said Isaac Foster, Chief Executive Officer of Front Range Pharmaceuticals. "Persistent fatigue and post-exertional symptoms can profoundly affect daily functioning in people with Long COVID, yet there are currently no FDA-approved treatments for the condition. Our Phase 2 study is designed to determine whether FRP-003 can meaningfully improve fatigue while also helping us identify the appropriate dose for future development."

Enrollment is expected to begin in 2027 and to take approximately 12 months. The study will be registered on ClinicalTrials.gov before enrollment begins.

About FRP-003

FRP-003 is an investigational, orally administered botanical drug candidate being developed in accordance with FDA's Botanical Drug Development guidance. FRP-003 is not approved by the FDA or any other regulatory authority, and its safety and efficacy have not been established.

About Long COVID

Long COVID is a chronic condition following SARS-CoV-2 infection that can include fatigue, post-exertional worsening of symptoms, sleep disturbance, cognitive difficulties, and impaired physical and social functioning, a pattern that overlaps with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Long COVID affects millions of adults in the United States, and there are no FDA-approved treatments for the condition.

About Front Range Pharmaceuticals

Front Range Pharmaceuticals, based in the Denver, Colorado area, is a clinical-stage pharmaceutical company developing standardized botanical drug candidates for conditions with significant unmet medical need. The company's pipeline includes programs in Long COVID and other neurological, psychiatric and inflammatory conditions. For more information, visit www.frontrangepharmaceuticals.com/.

Forward-Looking Statements

This press release contains forward-looking statements, including statements about the timing, design, conduct and potential results of the Phase 2 study of FRP-003 and the company's development plans. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in site activation or enrollment; FDA requests for additional nonclinical or clinical information that could delay, modify or suspend the study; and the risk that study results will not support further development. FRP-003 is investigational and may never be approved. The company undertakes no obligation to update these statements except as required by law.