Efficacy, Safety, and Tolerability of Remlarsen (MRG-201) Following Intradermal Injection in Subjects With a History of Keloids

Key Inclusion Criteria:

• Must provide written informed consent.
• Females must not be pregnant, or lactating, and have negative pregnancy tests.
• Study candidates should be likely to form keloids in the upper back/shoulder area after punch biopsy based on a history of a high frequency of keloid formation (≥ 10 keloids) or a history of large keloids (≥ 4 cm).
• Subjects should not anticipate requiring systemic corticosteroids during the study.
• Must have area in upper back/shoulder region free of keloids, acne, striae, or other skin pathologies or complications.
• Female subjects of childbearing potential or male subjects engaged in sexual relations with a female of childbearing potential must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.

Key Exclusion Criteria:

• Clinically significant abnormalities in medical history or physical exam that, in the opinion of the Investigator, would make the subject unsuitable for inclusion in the study.
• History of genetic disorders that predispose to keloids (e.g. Ehlers-Danlos syndrome, Ullrich congenital muscular dystrophy, etc.).
• History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening.
• Evidence of clinically significant anemia, neutropenia, or thrombocytopenia at screening.
• History of bleeding diathesis or coagulopathy.
• Active or uncontrolled infection at screening or baseline.
• Recent history of alcoholism, drug abuse or illicit drugs (within the last year), and agreement to refrain from using illicit drugs throughout the study.
• Positive for bloodborne pathogen (HBV, HCV, HIV) at screening.
• Prior malignancies within the past 3 years (allowing squamous cell and basal cell carcinomas that have been successfully treated).
• Use of systemic steroids within 4 weeks of the Baseline visit or local use of steroids within 1 week of the Baseline visit.
• Use of an investigational small molecule drug within 30 days of the baseline visit or use of an investigational oligonucleotide or biologic drug within 90 days of the baseline visit.