Phase 2a Study of Oral SUN-627 for Safety, Tolerability, PK/PD, and CNS Neuroinflammation in Non‑Active Progressive Multiple Sclerosis (SPMS/PPMS)

The primary objective is to evaluate the Multiple Sclerosis cohort for safety and tolerability of the oral 120 mg SUN-627 tablet, addressing a critical need to determine the adverse‑event profile in non‑active progressive disease. Secondary objectives include characterization of the pharmacokinetic profile of SUN-627, assessment of cerebrospinal fluid biomarkers linked to disease progression, and evaluation of neuroimaging measures of central nervous system inflammation, providing insight into pharmacodynamic effects and potential disease‑modifying activity.

The trial enrolled adult patients aged 18 to 70 years, inclusive, of both sexes, who had a diagnosis of Multiple Sclerosis meeting criteria for primary progressive disease or non‑active secondary progressive disease. Eligible individuals were required to have experienced no MS relapses in the preceding two years, demonstrated ongoing disease progression, and exhibited a level of disability compatible with the study’s requirements. The population was defined as patients, with inclusion of vulnerable subjects as permitted by the protocol. No specific dietary, physical activity, or other lifestyle restrictions were described. The sponsor did not provide information on the total number of participants.

The study is a Phase 2a, interventional trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and neuroinflammatory impact of the oral tablet SUN-627 (120 mg daily) in participants diagnosed with primary progressive multiple sclerosis or non‑active secondary progressive multiple sclerosis. Eligible adults aged 18–70 years with documented disease progression and no relapses in the preceding two years are enrolled. The trial employs a single‑arm design with participants receiving the investigational product for a treatment period of 12 weeks followed by a 4‑week safety follow‑up, yielding a total involvement of 16 weeks. Key methodological elements include systematic safety monitoring, collection of blood and cerebrospinal‑fluid biomarkers, and magnetic‑resonance imaging to assess inflammation. Study visits are scheduled as follows: a screening visit to confirm eligibility, a baseline visit (week 0) for first dose administration, follow‑up visits at weeks 4, 8, and 12 to evaluate adverse events, pharmacokinetic sampling, and biomarker endpoints, and an end‑of‑study visit at week 16 for final safety assessment. The primary endpoint is the incidence of treatment‑emergent adverse events and serious adverse events from enrollment through week 16; secondary endpoints comprise changes in disease markers in blood, brain fluid, and imaging from enrollment to week 12. Early termination may occur if a participant experiences a serious adverse event, an intolerable adverse reaction, withdraws consent, or fails to meet protocol‑compliance criteria.

The investigational product SUN-627 is supplied as a 120 mg oral tablet. The tablet is administered by the oral route. Dosing is performed according to the study schedule, with each dose consisting of a single 120 mg tablet.

The investigational product SUN-627 is supplied as a 120 mg oral tablet. The tablet is administered by the oral route. Dosing is performed according to the study schedule, with each dose consisting of a single 120 mg tablet.

The investigational product SUN-627 is supplied as a 120 mg oral tablet. The tablet is administered by the oral route. Dosing is performed according to the study schedule, with each dose consisting of a single 120 mg tablet.

Standard‑of‑care therapy, placebo, or other comparator treatments are not administered as part of this study. Participants receive only the investigational medication as described above.

Drug administration and participant compliance are monitored through scheduled clinic visits, pill counts, and electronic dosing diaries. Adherence to the dosing schedule is assessed at each visit, and any deviations are recorded in the study database.

Efficacy will be evaluated through quantitative assessment of disease‑related biomarkers in peripheral blood and central nervous system fluid, complemented by neuroimaging measures of inflammation. The selected parameters include laboratory‑derived markers of disease activity and magnetic resonance imaging indicators of inflammatory burden.

Samples for biomarker analysis and imaging studies will be obtained at baseline (enrollment) and at the end of the treatment period, corresponding to week 12. Laboratory assays will be performed using validated analytical methods, and imaging will be conducted with standard magnetic resonance protocols to ensure reproducibility. Collected data will be analyzed to detect changes from baseline, providing insight into the impact of SUN‑627 on neuroinflammatory processes in participants with Multiple Sclerosis.