Company Also Announces End-of-Phase II Meeting with FDA to Discuss Planned Phase III Program for SL1002 for the treatment of Spasticity

ROSWELL, Ga., DUBLIN and HAMILTON, Bermuda, Oct. 8, 2026 /PRNewswire/ -- Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced two clinical milestones for its investigational product SL1002, a novel targeted perineural chemoneurolytic injection utilizing the company's proprietary CYCLOPHLEX™ technology.

Saol has completed patient enrollment in the BEACON Trial (NCT07226258), its pivotal Phase III study evaluating SL1002 for the treatment of chronic pain related to osteoarthritis (OA) of the knee. Enrollment was completed on October 2, 2026, with over 20 U.S. sites participating in the trial.

Separately, the company has now been granted an End-of-Phase II meeting with the FDA to discuss the clinical development program for SL1002 for the treatment of spasticity, an additional investigational indication for the product.

ENROLLMENT COMPLETE IN PHASE III BEACON TRIAL

The BEACON Trial is a Phase III, randomized, double-blind, placebo-controlled, multicenter pivotal trial evaluating the safety and efficacy of SL1002 in patients with chronic pain due to osteoarthritis of the knee. Topline results are expected in the second quarter of 2027.

"Completing enrollment in BEACON is another significant step forward for the SL1002 program and most importantly, for the patients living with chronic knee pain that currently have limited non-opioid treatment options," said Dave Penake, Chief Executive Officer of Saol Therapeutics. "We sincerely appreciate our investigators, their teams, and the patients who participated in the BEACON trial. Along with some new sites for this study, nearly all our investigators from the Phase II COMPASS Trial (NCT05470608) returned for our Phase III study; their ongoing commitment to this program has been remarkable." 

"The completion of enrollment in the BEACON Trial is another step in potentially bringing an innovative new therapy to market," said Principal Investigator Ameet Nagpal, MD, Chief of Physical Medicine and Rehabilitation at the Medical University of South Carolina (MUSC). "There are millions of patients who are dealing with chronic knee pain related to osteoarthritis, and our team at MUSC is proud to have been part of another study with Saol Therapeutics to try to bring these patients a new non-opioid treatment option."

Saol plans to initiate an additional Phase III study in its knee pain program to support a planned regulatory filing, while also advancing multiple studies evaluating SL1002 in additional indications for the treatment of chronic pain and spasticity - conditions that affect millions of people in the United States.^1,2

UPDATE ON THE SL1002 PROGRAM FOR THE TREATMENT OF SPASTICITY

Saol's End-of-Phase II meeting with the FDA will address the clinical development plan for SL1002 in spasticity. This program follows separately from the knee pain program and reflects the company's continued interest in the compound's potential across multiple indications.

"Our upcoming End-of-Phase II meeting reflects the breadth of opportunity we see for SL1002 beyond a single indication," added Penake.

About SL1002

SL1002 is an investigational, novel, targeted perineural chemoneurolytic injection utilizing Saol's proprietary CYCLOPHLEX™ technology. SL1002 is being studied in adults (18+) for the treatment of chronic pain related to osteoarthritis of the knee and for the treatment of spasticity. SL1002 is not approved by the FDA or any other regulatory authority for any use.

About Saol Therapeutics

Saol Therapeutics (pronounced "Sail") is a privately held, clinical-stage pharmaceutical company with operations in Roswell, GA, Dublin, Ireland, and Hamilton, Bermuda. Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. For more information, visit www.saolrx.com.

Media Contact

Saol Therapeutics Chief Strategy Officer
Brian Nappi
bnappi@saolrx.com

1. Lucas JW, Sohi I. Chronic pain and high-impact chronic pain in U.S. adults, 2023. NCHS Data Brief, no 518. Hyattsville, MD: National Center for Health Statistics. 2024.
2. McGuire JR. Epidemiology of spasticity in the adult and child. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical; 2016:5-15.

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SOURCE Saol Therapeutics