CC-97489

Table of contents

• What is CC-97489?
• How does CC-97489 work?
• Which conditions is CC-97489 used or studied for?
• How is CC-97489 given?
• What do the clinical trials show?
• What side effects are known?

What is CC-97489?

CC-97489 is an investigational chemical substance, meaning it has no marketing authorisation in the product records reviewed here.^[1] It is also known by the alternative names BMS-986368 and irafamdastat, and is described as a dual FAAH/MAGL inhibitor.^[2] The substance is developed by Celgene Corporation, with Bristol-Myers Squibb International Corporation listed as an authorisation holder in registry records.^[1] In the AdisInsight drug profile, CC-97489 is classified among amides, antispastics, carbamates, carboxylic acids, ethers, fluorocarbons, neuroprotectants, piperazines, pyridines and small molecules.^[2]

How does CC-97489 work?

CC-97489 acts as a dual inhibitor of two enzymes: fatty acid amide hydrolase (FAAH) and monoacylglycerol lipase (MAGL).^[2] These enzymes break down endocannabinoids, which are natural signalling molecules in the nervous system. By blocking both enzymes, the substance is intended to increase levels of these molecules, which may influence muscle tone and spasticity. The mechanism of action is recorded in the AdisInsight profile as fatty acid amide hydrolase inhibitors and monoacylglycerol lipase inhibitors.^[2]

Which conditions is CC-97489 used or studied for?

In the registry data, CC-97489 is studied for one main condition:

• Multiple sclerosis spasticity — muscle stiffness and spasms that occur in people with multiple sclerosis, a disease of the central nervous system.^[1]

The therapeutic area in the registry covers immune system diseases and nervous system diseases.^[1] The AdisInsight profile also lists antispastics and behavioural disorder therapies among the drug classes, suggesting a broader interest in spasticity-related conditions.^[2]

How is CC-97489 given?

CC-97489 is formulated as a hard capsule and is given by oral use, meaning it is taken by mouth.^[1] In the Phase 2 trial, the studied doses are 1 mg and 3 mg capsules.^[1]

What do the clinical trials show?

One authorised Phase 2 trial in the EU registry is evaluating CC-97489 in participants with multiple sclerosis spasticity.^[1] The trial is interventional and plans to enrol 200 participants.^[1] The main goal is to understand the effect of BMS-986368 compared with placebo on spasticity in patients with MS.^[1]

The primary endpoint measures how much the stiffness in the person's most affected leg changes from the start of the study to the end of Week 6. This is assessed using a tool called the Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL).^[1] The trial compares CC-97489 against placebo, a pill with no medicine.^[1]

What side effects are known?

The AdisInsight profile includes an adverse events section, but the extract provided does not list specific side effects for CC-97489.^[2] No side effect data from the clinical trial registry is available at this stage, as the trial is authorised but not yet reported.