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Protagonist Therapeutics Announces Final Phase 1 Study Results with Novel Hepcidin Mimetic, PTG-300

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Friday, December 15, 2017

NEWARK, Calif. - Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced final top-line results from the randomized, placebo-controlled, single ascending- and repeat-dose Phase 1 study of PTG-300, the company's injectable hepcidin mimetic peptide, in normal healthy volunteers.

The results, which included the successful completion of the study extension to include two additional dose cohorts, confirm the previously announced preliminary data showing the ability of PTG-300 to achieve a dose-related and sustained effect on iron distribution based on reduction in serum iron and transferrin saturation. PTG-300 treatment was well-tolerated, with no serious adverse events or dose-limiting toxicities reported. The most common adverse events were localized and transient injection site reactions in some subjects.

"We are very pleased with the positive results from this initial safety, pharmacokinetic and pharmacodynamic (PD) study of PTG-300 in normal healthy volunteers," said Richard S. Shames, M.D., Protagonist Therapeutics Chief Medical Officer. "These results clearly demonstrate PD-based clinical proof-of-concept (POC) for PTG-300. They also set the stage for further discussions with the Health Authorities in early 2018, regarding our Investigational New Drug (IND) application and ex-U.S. clinical trial applications to initiate global trials of PTG-300 in patients with beta-thalassemia and myelodysplastic syndrome (MDS)."

About Hepcidin and Anemia/Iron Overload Diseases

PTG-300, an injectable hepcidin mimetic, is currently in clinical development for the potential treatment of beta-thalassemia and MDS, rare diseases characterized by chronic anemia and iron overload. PTG-300 therapy may also be beneficial in other diseases such as hereditary hemochromatosis, polycythemia vera, siderophilic infections, and liver fibrosis which provide opportunities for further development. Hepcidin is a peptide hormone that is the main regulatory hormone governing iron absorption, recycling and utilization by the body. Iron plays an essential role in various body functions, especially blood formation, but too much iron is toxic and causes organ damage over time. Abnormally low hepcidin levels, caused by genetic mutations or secondary pathology, can result in the body absorbing and storing more iron than is needed, leading to iron overload.

About Protagonist Therapeutics

Protagonist Therapeutics is a clinical-stage biopharmaceutical company with a proprietary technology platform which is utilized to discover and develop novel peptide-based drugs to address significant unmet medical needs. Its primary focus is on developing potential first-in-class, oral targeted therapy-based peptide drugs that work by blocking biological pathways that are currently targeted by marketed injectable antibody drugs. Protagonist's initial lead peptide product candidates, PTG-100 and PTG-200, are based on this approach, and the company believes these candidates have the potential to transform the existing treatment paradigm for inflammatory bowel disease (IBD), consisting primarily of ulcerative colitis and Crohn's disease.

PTG-100, a potential first-in-class oral peptide alpha-4-beta-7 integrin antagonist, is currently in a global Phase 2B clinical trial for the treatment of moderate-to-severe ulcerative colitis. PTG-200, a potential first-in-class oral Interleukin-23 receptor antagonist in development for the treatment of IBD, initially Crohn's disease, has entered 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.

In addition to PTG-100 and PTG-200, the company is developing an injectable hepcidin mimetic PTG-300 for the potential treatment of anemia and iron overload disorders, including rare diseases such as beta-thalassemia and MDS. PTG-300 has now completed a Phase 1 clinical trial.

Protagonist is headquartered in Newark, California with its pre-clinical and clinical staff in California, and discovery operations both in California and in Brisbane, Queensland, Australia. For further information, please visit http://www.protagonist-inc.com.

Contacts:

USA:

Corporate Headquarters
Protagonist Therapeutics Inc.

7707 Gateway Boulevard, Suite 140
Newark, CA 94560-1160
USA

Phone: +1 510 474 0170
Email: info@ptgx-inc.com

Australia:

Protagonist Pty Ltd

306 Carmody Road
St Lucia, Brisbane Qld 4072
Australia

Phone: +61 (7) 3346 2975
Fax: +61 (7) 3346 2379

Source: Protagonist Therapeutics, Inc.
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