On November 6, 2017 Protagonist Therapeutics, Inc. (NASDAQ: PTGX) reported its financial results for the third quarter and nine months ended September 30, 2017 and provided an update on the company’s recent achievements (Press release, Protagonist, NOV 6, 2017, View Source [SID1234521610]).
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“We recently reported positive preliminary Phase I results for PTG-300, our hepcidin mimetic in development for the potential treatment of anemia and iron overload related blood disorders, including rare diseases such as beta-thalassemia and myelodysplastic syndromes (MDS). These results, coupled with the encouraging Phase I results achieved for PTG-100 in 2016 and the recent partnership with Janssen for PTG-200, all provide validation for our novel peptide platform,” said Dinesh Patel, president and chief executive officer. “We plan to continue to execute on our strategy of optimizing our peptide technology platform and applying it to the discovery and development of drugs that address unmet medical needs and offer strong differentiation against existing treatments.”
Recent Pipeline Achievements
· PTG-300: The company reported preliminary results from a Phase 1 clinical trial of PTG-300, the company’s hepcidin mimetic, which demonstrated pharmacodynamic proof-of-concept in normal healthy volunteers. This data indicated that PTG-300 demonstrated a dose-related reduction in serum iron, which persisted beyond 72 hours at higher dose levels. PTG-300 showed a dose-dependent increase in blood drug levels and was well tolerated with no serious adverse events or dose-limiting toxicities. The company expects to report final top-line results from the complete study in the fourth quarter of 2017.
· PTG-100: The ongoing Phase 2B trial in ulcerative colitis patients remains on track to report interim futility analysis in early 2018 and top-line results in the second half of 2018. In parallel, the company is making all the preparations needed to support Phase 3 development.
· PTG-200: The company closed a license and collaboration agreement with Janssen Biotech, Inc. for clinical development of PTG-200. PTG-200 is expected to enter a Phase 1 clinical trial in the fourth quarter of 2017.