In short
SUN-627 is an investigational chemical substance developed by Sundance Biosciences Inc., currently studied as a tablet taken by mouth. It is being tested in people with non-active progressive forms of multiple sclerosis, including primary progressive MS (PPMS) and non-active secondary progressive MS (SPMS). One authorised Phase 2a trial with 30 participants is evaluating its safety, tolerability, and effects on measures of neuroinflammation in the central nervous system.
Key points
- SUN-627 is an investigational substance with no marketing authorisation in the product records.
- It is being studied as a 120 mg oral tablet in non-active progressive multiple sclerosis.
- The single authorised trial is a Phase 2a study with 30 participants.
- The primary outcome measures treatment-emergent adverse events and serious adverse events over 16 weeks.
- The trial also evaluates pharmacokinetics, pharmacodynamics, and neuroinflammation in the central nervous system.
- The trial is currently authorised, meaning it has received regulatory approval to proceed.
What is SUN-627?
SUN-627 is a chemically synthesised substance, meaning it is a small-molecule chemical compound rather than a protein-based medicine. It is classified in the therapeutic areas of nervous system diseases and immune system diseases. The substance is developed by Sundance Biosciences Inc. and appears in the product records under the single name SUN-627.
SUN-627 is an investigational substance with no marketing authorisation in the product records, meaning it has not yet been approved as a medicine for routine use. In the trials listed in the registry, SUN-627 is the substance being tested.
How does SUN-627 work?
The registry data do not describe the mechanism of action of SUN-627. The trial title indicates that the study evaluates the impact of SUN-627 on measures of neuroinflammation in the central nervous system, which suggests the substance is being investigated for its potential effect on inflammation in the brain and spinal cord. No molecular target or specific pathway is stated in the available data.
Which conditions is SUN-627 studied for?
- Multiple sclerosis — a chronic condition in which the immune system damages the protective covering of nerve fibres in the brain and spinal cord.
- Primary progressive multiple sclerosis (PPMS) — a form of multiple sclerosis characterised by steadily worsening neurological function from the start, without distinct relapses.
- Non-active secondary progressive multiple sclerosis (SPMS) — a later stage of relapsing-remitting multiple sclerosis in which disability progresses without new inflammatory activity on imaging.
These conditions are the focus of the single authorised trial of SUN-627.
How is SUN-627 given?
SUN-627 is formulated as a tablet for oral use, meaning it is taken by mouth. In the registered trial, the dose studied is 120 mg. The registry product records do not describe any other pharmaceutical forms or routes of administration.
What do the clinical trials show?
There is one authorised Phase 2a trial of SUN-627 registered, with a planned enrollment of 30 participants. The trial is interventional, meaning participants receive the study drug as part of the research plan. It is currently in the authorised status, which means it has received regulatory approval to proceed.
The primary outcome is the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), measured from enrollment to the end of the study at 16 weeks. The trial also evaluates pharmacokinetics, which describes how the body absorbs, distributes, breaks down, and removes a drug; pharmacodynamics, which describes the effects of a drug on the body; and measures of neuroinflammation in the central nervous system.
The trial is designed for participants with non-active progressive multiple sclerosis, specifically primary progressive multiple sclerosis and non-active secondary progressive multiple sclerosis. No results are reported in the registry data available here.