Saol Therapeutics Announces Positive Topline Results from the SL-1002 RAISE Limb Spasticity Trial

SL-1002 demonstrated a favorable safety profile in adult patients with limb spasticity, achieving the primary safety endpoint of this first-in-human study. Key secondary efficacy endpoints were also met, including a statistically significant reduction in the Modified Ashworth Score at 6 months.

ROSWELL, Ga. and DUBLIN and HAMILTON, Bermuda, Oct. 30, 2024 /PRNewswire/ -- Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced positive topline results from its SL-1002 RAISE Limb Spasticity Trial (NCT05311215). The data were recently presented at the Spasticity X Symposium in Houston, Texas.

Dr. Sheng Li, MD, PhD, Professor in the Department of Physical Medicine and Rehabilitation (PM&R) at McGovern Medical School at UTHealth Houston and Director of Stroke Rehabilitation and Recovery Research at TIRR Memorial Hermann Hospital, along with Dr. Gerard Francisco, MD, professor and The Wulfe Family Chair of Physical Medicine and Rehabilitation at McGovern Medical School at UTHealth Houston and Chief Medical Officer at TIRR Memorial Hermann, presented the findings.

SL-1002 is a novel chemoneurolytic injection utilizing Saol's proprietary CYCLOPHLEX™ technology. In the RAISE Limb Spasticity Trial, patients were randomized (3:1) into a double-blind, vehicle-controlled, single-ascending-dose escalation study designed to assess the safety and efficacy of a single SL-1002 treatment in patients with mild to severe limb spasticity. The study period lasted 26 weeks post-randomization, and the primary endpoint was to evaluate the overall safety profile of SL-1002 compared to vehicle.

A total of 32 patients were randomized in the trial (24 receiving SL-1002, 8 receiving vehicle). Five serious adverse events (SAEs) were reported, all determined by investigators to be unrelated to the treatment. Fourteen non-serious treatment-emergent adverse events (TEAEs) determined by the investigators to be possibly, probably, or definitely related to treatment were observed, all were considered mild. There were other mild and moderate non-serious treatment-emergent adverse events (TEAEs) considered by the investigators to be unrelated to the treatment. Overall, SL-1002 was deemed well-tolerated, with no therapy- or program-limiting adverse events.

Key secondary endpoints included assessments using the Modified Ashworth Scale (MAS), the most widely used efficacy measurement in spasticity trials. Despite the trial not being powered for efficacy, SL-1002 demonstrated a statistically significant improvement over vehicle at multiple time points throughout the trial. At 6 months, the SL-1002 arm showed a statistically significant reduction in MAS compared to baseline, with a decrease of -1.18, compared to -0.33 reduction in the vehicle arm (p=0.0060).

"We are thrilled to share the positive results from the RAISE Limb Spasticity Trial," said Dave Penake, CEO of Saol Therapeutics. "Spasticity can be an incredibly debilitating condition, and the need for new treatment options has been voiced by patients and clinicians. We are especially encouraged by the strong safety profile observed in the RAISE study, alongside the efficacy shown by SL-1002 lasting at least 6 months. Achieving a 1–2-point reduction in MAS is a significant, positive, clinical outcome, and the durability of the treatment give us great confidence in the future of this program."

Penake added, "None of this would have been possible without the patients who volunteered for this study and the dedicated investigators and clinical trial site teams. Their collaboration and commitment are what drive medical progress, and we are deeply grateful for their contributions."

Dr. Gerard Francisco, the Principal Investigator for the trial, commented, "Treating spasticity is complex, and there is an urgent need for more innovative therapies. These early results show that SL-1002 appears to be safe, effective, and durable. "

The RAISE Limb Spasticity Trial was conducted at UTHealth Houston in Houston, TX, where Dr. Sheng Li and Dr. Gerard Francisco served as the investigators, and at the Medical College of Wisconsin in Milwaukee, WI, where Dr. John McGuire served as the Principal Investigator.

Saol Therapeutics plans to meet with the FDA in the first half of 2025 to determine the next steps in the SL-1002 spasticity program. SL-1002 is also being investigated for the treatment of pain related to osteoarthritis of the knee in the COMPASS Osteoarthritis Knee Pain Trial, with results yet to be released.

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

About COMPASS Osteoarthritis Knee Pain Trial
In addition to the RAISE Spasticity Trial, SL-1002 is also being investigated for the treatment of pain related to osteoarthritis of the knee. The COMPASS Osteoarthritis Knee Pain Trial is a multicenter, randomized, double-blind, vehicle-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. (NCT05470608).

About SL-1002
SL-1002 is a novel, chemoneurolytic injection, that utilizes Saol's proprietary CYCLOPHLEX™ technology. It is currently being developed for the treatment of chronic knee pain related to osteoarthritis and limb spasticity, both in the adult population (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.

Saol Therapeutics Contact
Senior Vice President, Strategy
Brian Nappi
[email protected]

SOURCE Saol Therapeutics