Catabasis Pharmaceuticals has begun a PATHWAYS I, Phase II trial of CAT-2003, a new chemical entity that is a SMART Linker conjugate, in patients with hypertriglyceridemia and hypercholesterolemia.

The trial will assess the safety, tolerability and efficacy of CAT-2003 in patients with hypertriglyceridemia and in combination with statins in patients with hypercholesterolemia.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Catabasis chief medical officer Dr Joanne Donovan said that the positive Phase I data showed that CAT-2003 significantly reduced fasting and post-prandial triglyceride levels in healthy individuals and produced an improvement in lipid biomarkers such as LDL-C, ApoB and PCSK9.

“As a result of the inhibition of PCSK9 production we have observed with CAT-2003, we may see a synergistic effect with statins in lowering lipids such as LDL.”

“Because of these promising results, we are advancing CAT-2003 into Phase 2 to evaluate the drug’s effects in patients with hypertriglyceridemia and hypercholesterolemia,” Donovan added.

A total of 72 patients with moderate hypertriglyceridemia will be randomised with one of three doses of CAT-2003 or placebo for a period four weeks in the first arm of the double-blind, placebo-controlled Phase II study.

Fasting triglycerides and non-HDL-C in the patients will be measured and compared to baseline.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

A total of 24 patients with hypercholesterolemia on statins will be administered with either a specified dose of CAT-2003 or placebo once per day for four weeks in the second arm, in which fasting LDL-C levels will be assessed.

Catabasis co-founder and chief scientific officer Dr Michael Jirousek noted that CAT-2003 acts through the intracellular targeting of multiple nodes in the lipid synthesis pathway.

“One arm of this study will focus on evaluating the effect of CAT-2003 on lipid levels in combination with statins in patients with hypercholesterolemia,” Jirousek added.

“As a result of the inhibition of PCSK9 production we have observed with CAT-2003, we may see a synergistic effect with statins in lowering lipids such as LDL.”

The company expects top line data in the fourth quarter of 2013.