Pipeline

Oral Peptides Based Targeted Therapy for GI Diseases and Orphan 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

  • Complete Phase 2b Clinical Trial interim analysis in early 2018

PTG-100

α4β7 Antagonist

Oral IBD (Ulcerative Colitis)
  • Complete Phase 2b Clinical Trial interim analysis in early 2018

PTG-200 (Oral)

IL-23R Antagonist

  • Initiate Phase 1 Clinical Trial in 2017

PTG-200

IL-23R Antagonist

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

PTG-300 (Injectable Sub-Q)

Hepcidin Mimetic

  • Complete Phase 1 Clinical Trial in 2017

PTG-300

Hepcidin Mimetic

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

*Protagonist retains worldwide commercial rights to the PTG-100 and PTG-300 programs. PTG-200 is partnered with Janssen Biotech.

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-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. If you are interested in participating in a Phase 2b clinical trial evaluating PTG-100 in UC please follow the link to the PROPEL study. This study is for individuals suffering from moderate to severe active ulcerative colitis. A brief questionnaire can be completed to determine if you may qualify for participation.

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. Protagonist entered into a worldwide collaboration agreement for PTG-200 with Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, in May 2017.

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 Phase 1 clinical development. Hepcidin is a key hormone regulating iron homeostasis. PTG-300 has potential utility for the treatment of iron overload disorders such as β-Thalassemia, hereditary hemochromatosis (HH) and myelodysplastic syndrome (MDS), each of which may qualify for orphan designation.

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