Pipeline

Oral Peptides Based Targeted Therapy for GI Diseases and Disorders

Protagonist leverages its proprietary peptide technology platform to discover and develop novel product candidates to treat diseases with significant unmet medical needs.

Program* Dosing Form Indication Preclinical Phase 1 Phase 2 Anticipated Milestones

PTG-100 (Oral)

α4β7 Antagonist

  • Initiate Phase 2b Clinical Trial by the end of Q4 2016

PTG-100

α4β7 Antagonist

Oral IBD (Ulcerative Colitis)
  • Initiate Phase 2b Clinical Trial by the end of Q4 2016

PTG-200 (Oral)

IL-23 Antagonist

  • Initiate Phase 1 Clinical Trial in 2017

PTG-200

IL-23 Antagonist

Oral IBD (Crohn’s Disease)
  • Initiate Phase 1 Clinical Trial in 2017

PTG-300 (Injectable Sub-Q)

Hepcidin Mimetic

  • Initiate Phase 1 Clinical Trial in 2017

PTG-300

Hepcidin Mimetic

Injectable (Sub-Q) Iron Overload Disorders
  • Initiate Phase 1 Clinical Trial in 2017

*All Programs include worldwide commercial rights.

PTG-100: An Oral GI-Restricted α4β7 Integrin-Specific Antagonist for the Treatment of Moderate-to-Severe UC

PTG-100 is a potential first-in-class oral, alpha-4-beta-7 (α4β7) integrin-specific antagonist peptide product candidate which has now completed a Phase 1 clinical trial in normal healthy volunteers (NHVs), and is being developed initially for potential treatment of moderate-to-severe 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.

PTG-200: A First-in-Class Oral GI-Restricted IL-23R Antagonist for the Treatment of Moderate-to-Severe IBD

PTG-200 is a potential first-in-class oral Interleukin-23 receptor (IL-23R) antagonist being developed initially for moderate-to-severe CD. PTG-200 is currently in Investigational New Drug (IND) enabling studies, and we plan to initiate a Phase 1 clinical trial in 2017.

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. We believe these potential advantages could allow our products to replace and expand the IBD market beyond the moderate-to-severe IBD patient population currently treated by injectable antibody drugs.

PTG-300: An Injectable Hepcidin Mimetic for Potential Treatment of Iron Overload Related Rare Diseases

Our novel peptides have potential applicability in a wide range of therapeutic areas in addition to GI diseases. Our first product candidate beyond IBD is PTG-300, an injectable hepcidin mimetic, which is currently in pre-clinical development. PTG-300 has potential utility for the treatment of iron overload disorders, such as transfusion-dependent β-Thalassemia, hereditary hemochromatosis (HH) and sickle cell disease (SCD), each of which may qualify for orphan designation.

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