Pipeline

Peptides as Targeted Therapies for GI Diseases and Rare Blood Disorders

Protagonist leverages its proprietary peptide technology platform to discover and develop novel drug candidates that can transform the existing treatment paradigms in diseases with significant unmet medical needs.

Program Dosing Form Preclinical Phase 1 Phase 2 Milestones

PTG-100 (Oral)

α4β7 Antagonist IBD (UC)

  • Plans to discuss next steps in clinical development with FDA and other global health authorities in 2H 2018

PTG-100

α4β7 Antagonist IBD (UC)

Oral
  • Plans to discuss next steps in clinical development with FDA and other global health authorities in 2H 2018

PTG-200 (Oral)

IL-23R Antagonist IBD (Crohns)

Partnered with Janssen Biotech

  • Phase 1 initiated Q4 2017
  • Phase 1 completion 2H 2018

PTG-200

IL-23R Antagonist IBD (Crohns)

Partnered with Janssen Biotech

Oral
  • Phase 1 initiated Q4 2017
  • Phase 1 completion 2H 2018

PTG-300 (Injectable Sub-Q)

Hepcidin Mimetic β-Thalassemia

  • Phase 1 completed Q4 2017; established PD-based POC
  • Phase 2 initiation Q4 2018

PTG-300

Hepcidin Mimetic β-Thalassemia

Injectable (Sub-Q)
  • Phase 1 completed Q4 2017; established PD-based POC
  • Phase 2 initiation Q4 2018

We believe PTG-100 and PTG-200 have the potential to transform the existing IBD treatment paradigm because they offer significant advantages over injectable antibody drugs. These complementary assets target different biological pathways, and potentially offer improved convenience, patient compliance, and safety and tolerability compared to currently approved injectable antibody drugs. Furthermore, there is the potential to use PTG-100 and PTG-200 as monotherapies as well as in combination with each other or with other targeted therapies. We believe these potential advantages could also allow our products to expand the IBD market beyond the moderate-to-severe IBD patient population currently treated by injectable antibody drugs. PTG-300 has the potential to offer a novel approach for the treatment of anemia in patients with rare blood disorders such as β-Thalassemia.

PTG-100

PTG-100 is a potential first-in-class oral, alpha-4-beta-7 (α4β7) integrin-specific antagonist peptide product candidate which is being developed initially for potential treatment of moderate-to-severely active ulcerative colitis (UC). α4β7 integrin is considered to be one of the most GI-specific biological targets for IBD due to its binding to MAdCAM-1, an extracellular protein that resides mostly in the GI vasculature. Protagonist plans to discuss next steps in the clinical development of PTG-100 with the U.S. Food and Drug Administration (FDA) and other global health authorities in the second half of 2018.

PTG-200

PTG-200 is a potential first-in-class oral Interleukin-23 receptor (IL-23R) antagonist being developed initially for moderate-to-severely active Crohn’s disease (CD), and is currently completing a Phase 1 clinical trial. Protagonist has entered into a worldwide agreement with Janssen Biotech, Inc. to co-develop and commercialize PTG-200 for all indications, including IBD.

PTG-300

PTG-300, an injectable hepcidin mimetic, recently completed a Phase 1 clinical trial in healthy volunteers wherein we were able to establish a pharmacodynamic (PD) proof-of-concept (POC) based on dose-related reduction in serum iron levels. Hepcidin is a key hormone regulating iron homeostasis. PTG-300 has potential utility for the treatment of anemia in rare blood disorders such as β-Thalassemia. We plan to initiate a Phase 2 trial in patients with β-Thalassemia in the fourth quarter of 2018.


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