Saol Therapeutics Announces First Patient Enrolled in Phase 2 COMPASS Trial Evaluating the Safety and Efficacy Profile of SL-1002 for Treatment of Knee Pain Associated with Osteoarthritis

SL-1002 is also being concurrently studied for the treatment of limb spasticity in the Phase 2 RAISE Trial – topline data for both studies (pain and spasticity) is expected in 2023

ROSWELL, Ga. and DUBLIN and HAMILTON, Bermuda, Aug. 9, 2022 /PRNewswire/ -- Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that the first patient has been enrolled in the company's Phase 2 COMPASS Osteoarthritis Pain Trial. 

SL-1002 is a novel, proprietary chemoneurolytic injection currently under development at Saol Therapeutics and is being evaluated in the COMPASS Osteoarthritis Pain Trial. The trial is a multicenter, randomized, double-blind, placebo-controlled, single ascending-dose escalation study to assess the safety and efficacy of SL-1002 for the treatment of knee pain associated with osteoarthritis in adult patients (NCT05470608). The first patient in the trial was enrolled at the International Spine, Pain and Performance Center in Washington, D.C. 

"Our center is proud to enroll the first patient in Saol Therapeutics' COMPASS Osteoarthritis Pain Trial," said Investigator Mehul J. Desai, MD, President of the International Spine, Pain & Performance Center in Washington, DC. "Pain related to osteoarthritis of the knee is a condition that impacts millions of Americans, and while we have current approved treatments, there is a significant opportunity to improve on how we treat this population. We're excited to partner with Saol Therapeutics and the rest of the investigators around the United States in evaluating the potential of SL-1002."

Efficacy and safety are the two primary endpoints in the study.  The efficacy of SL-1002 will be assessed in comparison to placebo in its ability to reduce the average pain intensity at 3 months (12 weeks). The safety of SL-1002 will be assessed throughout the study in comparison to placebo when used for the treatment of knee pain associated with osteoarthritis. Additional secondary measures include improvements in function, concomitant medication and healthcare utilization.

"We are very enthusiastic to be partnering with Saol Therapeutics to investigate the use of SL-1002 in the COMPASS Osteoarthritis Pain Trial," said Principal Investigator Zachary McCormick, MD, Vice Chair and Associate Professor of Physical Medicine and Rehabilitation at the University of Utah. "There have been significant recent advancements in our understanding of the neuroanatomy of the knee with implications for enhancing the non-operative treatment of chronic knee pain due to osteoarthritis. While treatments have improved in the past decade, there remains a need for additional safe and more effective options that can be delivered in an efficient and patient-friendly way."

"The COMPASS Osteoarthritis Pain Trial marks another step in our commitment to develop innovative therapies for patients and the clinicians that treat them," said Saol Therapeutics CEO David Penake. 

In addition to the COMPASS Osteoarthritis Pain Trial, Saol Therapeutics recently announced that the first patient was enrolled in the RAISE Spasticity Trial (NCT05311215), evaluating the safety, pharmacokinetic and efficacy profile of SL-1002 in adult patients with limb spasticity.  Enrollment has advanced through completion of the first patient cohort.

"SL-1002 is a very exciting program.  Along with our announcement today that we have commenced enrollment in the COMPASS Osteoarthritis Pain Trial, in parallel we are rapidly enrolling patients in the RAISE Spasticity Trial," added Penake. "Beyond these two indications under investigation, our physician collaborators continue to stress to us that the characteristics of this novel agent may have broad applicability in multiple potential use cases. With the committed partnership of these thought leading collaborators, and the efforts of the Saol team, we plan to complete these studies and evaluate further indications as we approach our pivotal programs in spasticity and osteoarthritis knee pain." 

Saol Therapeutics currently expects topline results of both the COMPASS Osteoarthritis Pain Trial and the RAISE Spasticity Trial to readout in 2023.

About COMPASS Osteoarthritis Pain Trial
The COMPASS Osteoarthritis Pain Trial is a multicenter, randomized, double-blind, placebo-COntrolled, single-ascending dose escalation study to assess the safety and efficacy of SL-1002 injectable for treatMent of PAin aSSociated with OsteoArthritis of the knee.

Saol began enrolling patients in the COMPASS Osteoarthritis Pain Trial in the 3^rd Quarter of 2022. (NCT05470608).     

About RAISE Spasticity Trial
The RAISE Spasticity trial is a Randomized double-blind, placebo-controlled, single AscendIng dose escalation study to assess the Safety, Pharmacokinetics and Efficacy of SL-1002 in adult patients with limb spasticity. (NCT05311215).

The primary endpoint is the overall safety profile of a single treatment exposure of SL-1002 in comparison to placebo. Secondary endpoints include, but are not limited to, measures such as the Modified Ashworth Score (MAS), Clinical Global Impression of Change (CGI-C) and the Tardieu scale. Additional secondary measures include the characterization of the human pharmacokinetics and pharmacodynamics relating to metabolism and clearance of SL-1002 and its metabolites.

About SL-1002
SL-1002 is a novel, proprietary chemoneurolytic injection currently under investigation for the treatment of limb spasticity and in pain related to osteoarthritis of the knee in adults (18+) in the United States. 

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. 

SOURCE Saol Therapeutics