Saol Therapeutics News
Saol Therapeutics Announces Advancement into the Efficacy Expansion Cohort of the Phase II COMPASS Trial Evaluating the Safety and Efficacy Profile of SL-1002 for Treatment of Knee Pain Associated with Osteoarthritis
The third cohort of the COMPASS trial confirmed the highest planned dose target for the study is well tolerated.
ROSWELL, Ga, DUBLIN and HAMILTON, Bermuda, April 12, 2023 / – Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today the company’s Phase II COMPASS Trial is moving into the fourth and final cohort, where it will enroll approximately 100 patients.
SL-1002 is a novel, proprietary chemoneurolytic injection currently under development at Saol Therapeutics and is being evaluated in the COMPASS Osteoarthritis Knee 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).
“We are pleased that the Safety and Dose Escalation Committee (SDEC) continues to confirm that there have been no dose limiting adverse events in cohorts 1, 2 or 3. Saol will be advancing the COMPASS trial into the 4th and largest cohort to establish efficacy,” said Saol Therapeutics CEO David Penake.
In addition to the COMPASS Osteoarthritis Knee Pain Trial, Saol Therapeutics is also sponsoring the RAISE Spasticity Trial (NCT05311215), evaluating the safety, pharmacokinetics and efficacy profile of SL-1002 in adult patients with limb spasticity. Enrollment has also advanced through completion of the third patient cohort.
“SL-1002 continues to be an exciting program for our company and we are encouraged with the progress to date,” added Penake. “We want to thank the patients and clinicians for their partnership in our Phase II program.”
Saol Therapeutics currently expects topline results of both the COMPASS Osteoarthritis Knee Pain Trial and the RAISE Spasticity Trial to readout by early 2024.
About COMPASS Osteoarthritis Knee Pain Trial
The COMPASS Osteoarthritis Knee 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 3rd 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).
SL-1002 is a novel, proprietary chemoneurolytic injection currently under investigation for the treatment of limb spasticity and pain related to osteoarthritis of the knee in adults.
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.