View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
May 4, 2022

Saol doses first subject in Phase II limb spasticity treatment trial

The trial will evaluate the safety, pharmacokinetics and efficacy of SL-1002 in adults with limb spasticity.

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.

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.”

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU