Saol Therapeutics has dosed the first subject in the Phase II RAISE Spasticity trial of SL-1002 to treat adults with limb spasticity. The company anticipates topline findings from the trial next year.
A new nerve-blocking agent, SL-1002 is being developed to treat limb spasticity and pain linked to osteoarthritis of the knee in adults in the US.
The randomised, double-blind, placebo-controlled, single ascending-dose escalation Phase II trial will evaluate the safety, pharmacokinetics and efficacy of SL-1002 in adults with limb spasticity.
The overall safety profile of a single treatment exposure of SL-1002 versus placebo is the trial’s primary endpoint.
Assessments such as the Modified Ashworth Score (MAS), Clinical Global Impression of Change (CGI-C) and the Tardieu scale were included as the trial’s secondary endpoints.
Defining the human pharmacokinetics and pharmacodynamics linked to metabolism and clearance of SL-1002 and its metabolites were included as further secondary measures.
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Apart from the RAISE Spasticity trial, the company has initiated a second open investigational new drug application (IND) for SL-1002 to treat pain linked to knee osteoarthritis.
Named COMPASS Osteoarthritis Trial, the multicentre, randomised, double-blind, placebo-controlled, single-ascending dose-escalation study is anticipated to initiate dosing in the second quarter of this year.
It will evaluate the safety, pharmacokinetics and efficacy of an injectable dose of SL-1002 for knee osteoarthritis associated pain.
Saol Therapeutics CEO David Penake said: “Our recent strategic divestments have allowed Saol to expand investment in high-potential, clinical programmes, 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.”