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

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~ Saol Therapeutics, a clinical-stage pharmaceutical company, has recently announced positive results from its SL-1002 RAISE Limb Spasticity Trial. The data was presented at the Spasticity X Symposium in Houston, Texas by Dr. Sheng Li and Dr. Gerard Francisco.

The trial focused on the safety and efficacy of SL-1002, a novel chemoneurolytic injection utilizing Saol's proprietary CYCLOPHLEX™ technology. It was a double-blind, vehicle-controlled study that included 32 patients with mild to severe limb spasticity. The primary endpoint was to evaluate the overall safety profile of SL-1002 compared to the vehicle.

The results showed that SL-1002 was well-tolerated with no therapy or program-limiting adverse events reported. Out of the 32 patients, 24 received SL-1002 while 8 received the vehicle. Five serious adverse events (SAEs) were reported but were determined by investigators to be unrelated to the treatment. Fourteen non-serious treatment-emergent adverse events (TEAEs) were observed and considered mild by investigators.

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The secondary endpoints included assessments using the Modified Ashworth Scale (MAS), which is commonly used in spasticity trials. Despite not being powered for efficacy, SL-1002 showed a statistically significant improvement over the vehicle at multiple time points throughout the trial. At 6 months, there was a significant reduction in MAS compared to baseline in the SL-1002 arm (-1.18) compared to the vehicle arm (-0.33).

Dave Penake, CEO of Saol Therapeutics, expressed his excitement about these positive results and acknowledged the need for new treatment options for spasticity. He also highlighted the strong safety profile observed in this trial and the long-lasting efficacy of SL-1002.

Penake also thanked all those involved in making this trial possible, including patients, investigators, and clinical trial site teams. He emphasized their collaboration and commitment as the driving force behind medical progress.

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Dr. Gerard Francisco, the Principal Investigator for the trial, commented on the urgent need for more innovative therapies to treat spasticity. He also noted that these early results show that SL-1002 is safe, effective, and durable.

The RAISE Limb Spasticity Trial was conducted at UTHealth Houston in Houston, TX, and the Medical College of Wisconsin in Milwaukee, WI. Saol Therapeutics plans to meet with the FDA in the first half of 2025 to determine the next steps for SL-1002 in its spasticity program.

In addition to limb spasticity, SL-1002 is also being investigated for its potential to treat pain related to osteoarthritis of the knee in the COMPASS Osteoarthritis Knee Pain Trial. Results from this trial are yet to be released.

Saol Therapeutics is dedicated to developing innovative treatments for debilitating conditions like spasticity and osteoarthritis. With these positive results from their RAISE Limb Spasticity Trial, they are one step closer to providing much-needed relief for patients suffering from these conditions.
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