PN-881 / Protagonist Therap - LARVOL DELTA

PN-881: Initiation of P2 trial for hidradenitis suppurativa in H1 2028 (Protagonist Therapeutics) - Company Overview

New P2 trial • Hidradenitis Suppurativa

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects. (clinicaltrials.gov) - P1 | N=146 | Completed | Sponsor: Protagonist Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

Wholly-Owned Clinical and Discovery Programs: PN-881 (ACCESS Newswire) - "PN-881 (oral IL-17 antagonist peptide): Pharmacokinetic data from the Phase 1 study supports the decision to advance PN-881 into a comprehensive Phase 2 psoriasis program, with initiation expected in early Q1 2027. PN-881 achieved 24-hour Ctrough levels significantly higher than prospectively targeted IC90 (IL-17AA, IL-17FF, IL-17AA+FF) values with once-daily oral dosing."

New P2 trial • P1 data • PK/PD data • Psoriasis

PN-881: Initiation of P2 trial for hidradenitis suppurativa in 2027 (Protagonist Therapeutics) - Corporate Presentation

New P2 trial • Hidradenitis Suppurativa

Clinical Programs (ACCESS Newswire) - "The Company expects its Phase 1 study of PN-881 to be complete by mid-2026, informing subsequent clinical development plans."

Trial status • Psoriasis

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects. (clinicaltrials.gov) - P1 | N=142 | Recruiting | Sponsor: Protagonist Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

The first human subject has been dosed in the Phase 1 trial ( NCT07153146 ) of PN-881, a first-in-class oral IL-17 peptide antagonist, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult participants (ACCESS Newswire)

Trial status • Hidradenitis Suppurativa • Psoriasis • Psoriatic Arthritis

PN-881: a first-in-class oral IL-17 antagonist peptide for potential treatment of psoriatic diseases (EADV 2025) - "Potency was determined using concentrations of PN-881 or bimekizumab-bkzx leading to 50% inhibition (IC50) of IL-6 or BD2. The potencies in the various pre-clinical assays, PD and efficiacy data confirm the potential of PN-881 as a first-in- class oral peptide targeting all three IL-17 mediators of skin inflammation."

Ankylosing Spondylitis • Dermatitis • Dermatology • Fibrosarcoma • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Sarcoma • Seronegative Spondyloarthropathies • Solid Tumor • Spondylarthritis • CXCL1 • IL23A • IL6 • TNFA

PN-881 Study Data (ACCESS Newswire) - "The Company expects that the first subject will be dosed in the Phase 1 single ascending and multiple ascending dose human clinical study (NCT07153146) in the coming weeks....Exhibited in vitro potency comparable to bimekizumab, and superior (70-fold) to secukinumab, in the nanomolar to picomolar range; Showed metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery; Demonstrated PD-based target engagement in a mouse IL-17 challenge model after oral dosing; Oral dosing showed dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model."

Preclinical • Trial status • Psoriasis

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects. (clinicaltrials.gov) - P1 | N=142 | Not yet recruiting | Sponsor: Protagonist Therapeutics, Inc.

New P1 trial

PN-881: First-in-class oral peptide targeting the IL–17 pathway (SID 2025) - "PN-881 inhibits IL-17-induced IL-6 production in human HT-1080 fibrosarcoma cells and in primary human dermal fibroblasts (nHDF) with concentration-dependent potency (IC50) values comparable to bimekizumab. PN-881 also dose-dependently inhibited IL-23-induced rat skin inflammation and thickening with significant effects at oral doses as low as 2 mg/kg/day. These preclinical potency, PK, PD, and efficacy results support the potential for a first-in-class oral peptide targeting IL-17-mediated diseases."

Ankylosing Spondylitis • Dermatitis • Dermatology • Fibrosarcoma • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Sarcoma • Seronegative Spondyloarthropathies • Solid Tumor • Spondylarthritis • CXCL1 • IL23A • IL6

Protagonist Announces...Preclinical Data on PN-881 Presented at the Society for Investigative Dermatology Annual Meeting (ACCESSWIRE) - "PN-881 represents Protagonist's next generation of oral peptides for psoriasis. Key takeaways from the pre-clinical characterization of the IL-17 oral peptide antagonist PN-881: Exhibited nanomolar to picomolar in vitro potency comparable to bimekizumab and superior (70-fold) to secukinumab; Showed metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery; Demonstrated PD-based target engagement in a mouse IL-17 challenge model after oral dosing; Demonstrated dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model after oral dosing....'We look forward to progressing our fully owned asset PN-881 in human clinical studies in Q4 2025.'"

New trial • Preclinical • Psoriasis