Saol Therapeutics Announces First Patient Enrolled in Phase 2 RAISE Spasticity Trial Evaluating the Safety Profile of SL-1002 for Limb Spasticity

Topline Data Expected in 2023

ROSWELL, Ga. and DUBLIN and HAMILTON, Bermuda, May 3, 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 RAISE Spasticity Trial. 

SL-1002 is a novel, proprietary chemoneurolytic injection currently under development at Saol Therapeutics and is being evaluated in the RAISE Spasticity Trial.  The trial is a 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. 

"We are extremely excited to be working with Saol Therapeutics to investigate SL-1002 in the RAISE Spasticity Trial," said Principal Investigator John McGuire, a professor of Physical Medicine and Rehabilitation at the Medical College of Wisconsin.  "Despite the number of current treatments for spasticity, there remains a need for additional effective and reliable options."

"I am very proud of the work the team at Saol Therapeutics has done to achieve this important milestone for our company," said Saol Therapeutics CEO, David Penake.  "Saol has heard from countless physicians about the need for efficacious, long-acting therapeutic agents to help manage spasticity, and we are grateful for the partnership of our trial sites to help advance the development of this therapy."

In addition to the RAISE Spasticity Trial for the treatment of spasticity, Saol Therapeutics also announced a second open IND for SL-1002 for the treatment of pain related to osteoarthritis of the knee.  The first patient in that trial – the COMPASS Osteoarthritis Trial – is expected to be enrolled in Q2, 2022. 

"Our recent strategic divestments have allowed Saol to expand investment in high-potential, clinical programs, including an additional study to evaluate the safety and efficacy of SL-1002 in patients with pain related to osteoarthritis of the knee. After successfully opening a second IND, we are ramping towards enrolling the first patient into the COMPASS Osteoarthritis Trial." added Penake.  "Additionally, beyond the treatment of spasticity and pain related to osteoarthritis of the knee, we believe SL-1002 could have applicability in multiple potential conditions that we are currently exploring."

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

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

Saol expects to begin enrolling patients in the COMPASS Osteoarthritis Trial in the 2^nd Quarter of 2022. 

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 clinical 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