OR-101 / Arrien, Ornovi - LARVOL DELTA

A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Ornovi, Inc. | N=128 ➔ 0 | Trial completion date: Jun 2024 ➔ Feb 2024 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jun 2024 ➔ Feb 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Alopecia • Dermatology • Immunology

A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects (clinicaltrials.gov) - P1 | N=128 | Not yet recruiting | Sponsor: Ornovi, Inc.

New P1 trial • Alopecia

Ornovi Announces Positive Data in Inflammatory Skin Animal Models with a new selective JAK3 (PRNewswire) - "Ornovi, Inc...announced a Hot Topics presentation for its lead candidate, OR-101 at the 25th World Congress of Dermatology Meeting 2023, on July 7th in Singapore....The talk will feature the unique profile of OR-101, which positions it as a fast follow-on/next generation product to Ritlecitinib and other marketed JAK products. Highlights will include the data from inflammatory skin disorders models such as psoriasis, alopecia areata, and atopic dermatitis."

Preclinical • Alopecia • Atopic Dermatitis • Immunology • Psoriasis

OR-101: A next generation JAK3 selective compound (ISID 2023) - "Kinase activity differences were confirmed usingthe KINOMEscan assay: both OR101 and ritlecitinib exhibited potent JAK3 activity.OR101 was 2 to 165-fold more selective than ritlecitinib with additional kinases(BLK, BTK, EGFR, ITK, JAK1, JAK2, TYK2), suggesting an improved selectivity profile.Cytokine release assays stimulated peripheral blood mononuclear cells from healthyhumans with anti-CD3 to activate T cells in the presence/absence of OR-101 orritlecitinib for 24 hours. While inhibitory activity was similar against IL-2, IL-6, andIFN-g for both products, OR101 exhibited greater inhibitory activity against IL-4 andIL-15. These studies confirm the JAK3 selective profile of OR101 and suggest itspotential in inflammatory diseases characterized by JAK3 driven inflammation."

Late-breaking abstract • Inflammation • EGFR • IL2RA • IL4R • IL6 • JAK1 • JAK2 • JAK3 • TYK2