Company Also Secures FDA End-of-Phase 2 Meeting to Discuss SL1002 Development for Spasticity; Topline Knee Pain Results Expected in Q2 2027
Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, has announced two key clinical development milestones for SL1002, its investigational targeted perineural chemoneurolytic injection based on proprietary CYCLOPHLEX™ technology.
The company has completed patient enrollment in the pivotal Phase 3 BEACON trial evaluating SL1002 for chronic pain associated with knee osteoarthritis (OA). Separately, the U.S. Food and Drug Administration (FDA) has granted Saol an End-of-Phase 2 meeting to discuss the clinical development program for SL1002 in spasticity.
Key Highlights
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Phase 3 enrollment completed: The BEACON trial completed patient enrollment on October 2, 2026, across more than 20 U.S. clinical sites.
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Topline results expected: Initial results from the BEACON trial are anticipated in the second quarter of 2027.
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FDA meeting secured: Saol will discuss the next steps for developing SL1002 as a potential treatment for spasticity.
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Multiple indications under investigation: The company is advancing SL1002 for chronic knee pain and spasticity.
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Additional Phase 3 study planned: Saol intends to initiate another Phase 3 knee pain study to support a planned regulatory filing.
Phase 3 BEACON Trial: Enrollment Complete
Saol Therapeutics has completed enrollment in the Phase 3 BEACON trial (NCT07226258), a pivotal clinical study investigating SL1002 for chronic pain associated with knee osteoarthritis.
The trial is being conducted at more than 20 sites across the United States and is designed to evaluate the safety and efficacy of SL1002 in adults experiencing chronic knee pain due to osteoarthritis.
BEACON Trial Design
| Study Feature | Details |
|---|---|
| Trial phase | Phase 3 |
| Clinical trial identifier | NCT07226258 |
| Indication | Chronic pain associated with knee osteoarthritis |
| Study design | Randomized, double-blind, placebo-controlled, multicenter |
| Enrollment status | Complete |
| Enrollment completion date | October 2, 2026 |
| Expected topline results | Q2 2027 |
The company plans to initiate an additional Phase 3 study in its knee pain program to support a planned regulatory submission.
Company and Investigator Perspectives
Dave Penake, Chief Executive Officer of Saol Therapeutics, described completion of BEACON enrollment as an important milestone for the SL1002 program and for patients who have limited non-opioid treatment options for chronic knee pain.
He also acknowledged the contributions of participating patients, investigators, and clinical research teams. According to Penake, nearly all investigators from the earlier Phase 2 COMPASS trial (NCT05470608) returned to participate in the Phase 3 study.
Ameet Nagpal, MD, Principal Investigator and Chief of Physical Medicine and Rehabilitation at the Medical University of South Carolina (MUSC), highlighted the need for additional treatment options for the millions of people affected by knee osteoarthritis pain. He noted that the MUSC team was pleased to participate in another study with Saol to evaluate a potential non-opioid treatment option.
SL1002 Development Program for Spasticity
In a separate development, Saol Therapeutics has secured an End-of-Phase 2 meeting with the FDA to discuss the clinical development plan for SL1002 in spasticity.
The meeting will focus on the next steps for advancing the investigational therapy in this indication. The spasticity program is being developed separately from the knee osteoarthritis pain program.
Penake stated that the planned FDA meeting reflects the company's interest in exploring SL1002's potential across multiple indications.
About SL1002
SL1002 is an investigational targeted perineural chemoneurolytic injection that uses Saol Therapeutics' proprietary CYCLOPHLEX™ technology.
The therapy is being studied in adults aged 18 years and older for two indications:
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Chronic pain associated with knee osteoarthritis.
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Spasticity.
The company is evaluating SL1002 as a potential treatment option in these conditions. Its safety and efficacy remain under clinical investigation.
Regulatory status: SL1002 has not been 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, Georgia; Dublin, Ireland; and Hamilton, Bermuda.
The company focuses on developing treatments for central nervous system (CNS) disorders, including spasticity and pain management, as well as orphan diseases. Saol aims to advance therapeutic options for patients and the healthcare professionals who treat them.
For more information, visit www.saolrx.com.
