Saol Therapeutics Reports Positive Results from SL-1002 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.

Saol Therapeutics, a clinical-stage pharmaceutical company, has shared positive topline results from its SL-1002 RAISE Limb Spasticity Trial (NCT05311215). These findings were recently presented at the Spasticity X Symposium in Houston, Texas by Dr. Sheng Li and Dr. Gerard Francisco. Both are esteemed professors and heads of significant departments at McGovern Medical School at UTHealth Houston.

SL-1002 is a novel chemoneurolytic injection that uses Saol's proprietary CYCLOPHLEX™ technology. In the trial, patients with varying degrees of limb spasticity were divided into two groups: one receiving SL-1002 and the other a vehicle. This double-blind study aimed to assess the safety and efficacy of a single SL-1002 treatment over a 26-week period.

A total of 32 patients participated in the trial, with 24 receiving SL-1002 and 8 receiving the vehicle. The study reported five serious adverse events (SAEs), all of which were not related to the treatment. Additionally, 14 non-serious treatment-emergent adverse events (TEAEs) were noted as possibly, probably, or definitely related to the treatment, all of which were mild. There were also mild and moderate non-serious TEAEs deemed unrelated to the treatment. SL-1002 was considered well-tolerated, with no therapy- or program-limiting adverse events.

Secondary endpoints of the trial included assessments using the Modified Ashworth Scale (MAS), a widely recognized measure in spasticity trials. Although the trial was not designed with efficacy as its primary focus, SL-1002 showed a statistically significant improvement over the vehicle at various points during the study. After six months, the SL-1002 group exhibited a notable reduction in MAS scores compared to baseline, with a decrease of -1.18, as opposed to a -0.33 decrease in the vehicle group.

"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 gives us great confidence in the future of this program."

Penake continued, expressing gratitude towards the patients who participated in the study and the dedication of the investigators and clinical trial site teams. Their collaboration is deemed essential for advancing medical progress.

Dr. Gerard Francisco, the Principal Investigator, commented on the complexity of treating spasticity and the urgent need for innovative therapies. He noted that the early results suggest SL-1002 is safe, effective, and has lasting benefits.

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

Saol Therapeutics plans to discuss the next steps for the SL-1002 spasticity program with the FDA in the first half of 2025. SL-1002 is also being investigated in the COMPASS Osteoarthritis Knee Pain Trial for treating pain associated with osteoarthritis of the knee, with results pending.

SL-1002 is a chemoneurolytic injection developed using Saol's proprietary CYCLOPHLEX™ technology. It is being developed to treat chronic knee pain linked to osteoarthritis and limb spasticity in adults in the United States.

Saol Therapeutics is focused on developing therapies for CNS disorders, spasticity, pain management, and orphan diseases. The company operates in Roswell, GA, Dublin, Ireland, and Hamilton, Bermuda, and is dedicated to advancing therapeutic options for patients and their physicians.