— Safety, tolerability and pharmacokinetics results expected in 2021 —
NEWARK, CA, USA I December 16, 2020 I Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first subject has been dosed in a Phase 1 study of PN-235 (also referenced as JNJ-77242113), an oral interleukin-23 receptor (IL-23R) antagonist peptide. The study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in approximately 100 healthy volunteers. PN-235 is being developed as part of a portfolio strategy of discovering and developing oral IL-23 receptor antagonists as part of an ongoing collaboration with Janssen Biotech, Inc.
“PN-235 is the first second-generation, oral, IL-23 receptor antagonist candidate as part of our research collaboration with Janssen to enter clinical development and was discovered through the application of the Protagonist peptide technology platform,” commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. “We are extremely pleased with the success of our collaborative efforts, and see significant potential for multiple indications with orally delivered therapeutics that act by targeting the well-validated IL-23 pathway. We expect Phase 1 results in 2021.”
The PN-235 Phase 1 study will be conducted in three parts: a single ascending dose, a multiple ascending dose, and a randomized, crossover solid dose comparison part. The primary endpoint is safety as measured by number and severity of adverse events. Secondary outcomes include pharmacokinetics measurements of peak concentration (Cmax) of and area under the curve (AUC). Information on the study is available at https://clinicaltrials.gov/ct2/show/NCT04621630.
Protagonist and Janssen have established a co-development and commercialization agreement for IL-23 receptor targeted therapeutics with applications in various disease areas. According to the terms of the agreement, Janssen will be responsible for further development and commercialization activities of candidates beyond Phase 2 development. Protagonist is eligible to receive research, development, regulatory and sales milestone payments and has an option to co-detail products in the U.S. market.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing treatment paradigms for patients. PTG-300 is an injectable hepcidin mimetic in development for the treatment of polycythemia vera and other blood disorders. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in development for the treatment of inflammatory bowel disease, with Crohn’s disease as the initial indication. In addition to PTG-200, two oral peptide interleukin-23 receptor antagonist candidates are in development and have been selected for advancement into clinical studies. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in development for the treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication.
Protagonist is headquartered in Newark, California. For further information, please visit www.protagonist-inc.com.
SOURCE: Protagonist Therapeutics
Post Views: 591
— Safety, tolerability and pharmacokinetics results expected in 2021 —
NEWARK, CA, USA I December 16, 2020 I Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first subject has been dosed in a Phase 1 study of PN-235 (also referenced as JNJ-77242113), an oral interleukin-23 receptor (IL-23R) antagonist peptide. The study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in approximately 100 healthy volunteers. PN-235 is being developed as part of a portfolio strategy of discovering and developing oral IL-23 receptor antagonists as part of an ongoing collaboration with Janssen Biotech, Inc.
“PN-235 is the first second-generation, oral, IL-23 receptor antagonist candidate as part of our research collaboration with Janssen to enter clinical development and was discovered through the application of the Protagonist peptide technology platform,” commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. “We are extremely pleased with the success of our collaborative efforts, and see significant potential for multiple indications with orally delivered therapeutics that act by targeting the well-validated IL-23 pathway. We expect Phase 1 results in 2021.”
The PN-235 Phase 1 study will be conducted in three parts: a single ascending dose, a multiple ascending dose, and a randomized, crossover solid dose comparison part. The primary endpoint is safety as measured by number and severity of adverse events. Secondary outcomes include pharmacokinetics measurements of peak concentration (Cmax) of and area under the curve (AUC). Information on the study is available at https://clinicaltrials.gov/ct2/show/NCT04621630.
Protagonist and Janssen have established a co-development and commercialization agreement for IL-23 receptor targeted therapeutics with applications in various disease areas. According to the terms of the agreement, Janssen will be responsible for further development and commercialization activities of candidates beyond Phase 2 development. Protagonist is eligible to receive research, development, regulatory and sales milestone payments and has an option to co-detail products in the U.S. market.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing treatment paradigms for patients. PTG-300 is an injectable hepcidin mimetic in development for the treatment of polycythemia vera and other blood disorders. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in development for the treatment of inflammatory bowel disease, with Crohn’s disease as the initial indication. In addition to PTG-200, two oral peptide interleukin-23 receptor antagonist candidates are in development and have been selected for advancement into clinical studies. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in development for the treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication.
Protagonist is headquartered in Newark, California. For further information, please visit www.protagonist-inc.com.
SOURCE: Protagonist Therapeutics
Post Views: 591
