Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects with Relapsing-Remitting Multiple Sclerosis

Inclusion Criteria:

• Subject is fluent in English.

• Male or female 18 to 50 years of age, inclusive, at the first Screening visit.

• A diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017Revised McDonald Criteria.

• Expanded Disability Status Scale (EDSS) and retinal nerve fiber layer withinprotocol requirements.

• Stable immunomodulatory treatment on no more than a single DMT for RRMS over the 6months prior to Screening, as determined by the PI.

• Male or female subjects with reproductive potential agree to comply with a highlyeffective contraceptive method as per protocol through 1 month after last study drugadministration as per protocol.

• General good medical health with no clinically significant or relevant abnormalitiesexcept those attributed to the underlying multiple sclerosis (MS), including medicalhistory, physical exam, vital signs, ECG and laboratory evaluations, as assessed bythe Investigator.

If enrolled in the visual evoked potential (VEP) sub-study, an additional inclusion criterion includes:

• Screening VEP P100 latency greater than the upper limit of normal (as defined in theprotocol) in at least one eye, OR a protocol-defined difference in VEP P100 latencybetween eyes.

Exclusion Criteria:

• Diagnosis or history of symptoms of optic neuritis within 9 months prior toScreening in either eye.

• Diagnosis of MS more than 10 years prior to Screening.

• History of severe myopia, ophthalmologic or retinal disorder that would interferewith measurements of low contrast letter acuity (LCLA) or exam by optical coherencetomography (OCT), as determined by Investigator.

• Concurrent use of dalfampridine or other 4-aminopyridine or diamino-4-aminopyridinedrugs.

• Clinical MS relapse or MS related treatment with corticosteroids within 6 monthsprior to or during Screening.

• History of treatment with bone marrow transplantation, mitoxantrone,cyclophosphamide, atacicept, or irradiation.

• Use of any daily or routine anticholinergic medications within 30 days of Screeningor concurrent during the study.

• The presence of gadolinium enhancing lesions by MRI.

• Use of any drugs known to strongly or moderately induce or inhibit Cytochrome P450 3A4 (CYP3A4) enzyme activity within 30 days prior to Screening or concurrent duringthe study.

• Use of an investigational product, vaccine or intervention other than anon-interventional registry study within the greater of 30 days or 5 half-lives (ifknown) prior to Screening or expected during the study.

• History of malignancy under current active treatment or considered at substantialrisk for progression or recurrence during the study interval, and/or significantcardiac disorder or dysrhythmia, as determined by the Investigator.

• History of a suicide attempt or suicidal behavior or considered at risk for suicideas judged by the PI using the Columbia-Suicide Severity Rating Scale (C-SSRS) asScreening.

If enrolled in the visual evoked potential (VEP) sub-study, an additional exclusion criterion includes:

• History of an ophthalmologic or retinal disorder that would interfere withmeasurements of VEP, as determined by the Investigator.