Saol Therapeutics has enrolled the first subject in the Phase II COMPASS Osteoarthritis Pain Trial of SL-1002 in adults to treat knee pain linked to osteoarthritis.
The first subject was enrolled at the International Spine, Pain and Performance Center in Washington, DC, US.
The multicentre, double-blind, randomised, placebo-controlled, single ascending-dose escalation trial will analyse the safety and efficacy of SL-1002 to treat osteoarthritis-associated knee pain.
Efficacy and safety are the trial’s primary endpoints.
Saol plans to evaluate SL-1002’s efficacy by analysing its potential to lower the average pain intensity at 12 weeks versus a placebo.
The therapy’s safety will be analysed throughout the trial versus placebo.
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Improvements in function, concurrent treatment and healthcare utilisation will be included as further secondary measures.
A new nerve-blocking agent, SL-1002 is also being analysed to treat limb spasticity as well as pain linked to knee osteoarthritis in adults aged18 years and above in the US.
Apart from COMPASS Osteoarthritis Pain Trial, the therapy is being analysed to treat limb spasticity in the Phase II RAISE Trial.
The RAISE Trial is analysing SL-1002’s safety, pharmacokinetic and efficacy profile in adults with limb spasticity.
So far, the trial concluded enrolment in the first subject cohort.
Topline findings for both trials are anticipated in the next year.
Saol Therapeutics CEO David Penake said: “SL-1002 is a very exciting programme. Along with our announcement today that we have commenced enrolment in the COMPASS Osteoarthritis Pain Trial, in parallel we are rapidly enrolling patients in the RAISE Spasticity Trial.
“Beyond these two indications under investigation, our physician collaborators continue to stress to us that the characteristics of this novel agent may have broad applicability in multiple potential use cases.”