May 30, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEWARK, Calif. – Investors in Protagonist Therapeutics are excited after Janssen, the subsidiary of drug giant Johnson & Johnson inked a collaboration deal worth nearly $1 billion to develop the company’s treatment for a variety of gastrointestinal diseases, including Crohn’s and inflammatory bowel syndrome.
The two companies are joining forces to develop and market PTG-200, Protagonist’s first-in-class, oral peptide Interleukin-23 receptor antagonist. The drug is currently in preclinical studies and is expected to being in Phase I clinical trials in the second half of 2017, Protagonist said this morning in a statement announcing the deal with Janssen.
According to the Form 8-K filed with the U.S. Securities and Exchange Commission, Protagonist will be responsible for the Phase I trial and then Janssen will be responsible for the Phase II portion. Janssen will provide 80 percent of the financing for the Phase II trial. If the companies move past the Phase II phase, Protagonist could earn substantially more from Janssen. If Janssen moves the drug into a Phase IIb trial, Protagonist could earn an additional $125 million. They could earn an additional $200 million if Janssen takes the drug into a Phase III trial, according to the Form 8-K.
PTG-200 works by blocking the IL-23 pathway, a mechanism which has been proven by injectable antibodies. David Y. Liu, Protagonist’s chief scientific officer and head of R&D, said they believe the company’s technology platform is “validated in its ability to generate potential first-in-class oral peptides as the next generation of targeted therapy drugs for IBD.”
Protagonist believes that PTG-200 has the potential to become a transformative treatment in IBD. The company said the oral drug is designed to offer significant advantages over injectable antibody drugs, including improved convenience, patient compliance and the potential for improved safety and tolerability compared to currently approved injectable antibody drugs.
Under terms of the deal Johnson & Johnson Innovation , the pharma giant’s investment arm, will provide $50 million in upfront financing for the drug’s development, with another $94 million in potential milestones. Protagonist Therapeutics and Janssen will jointly conduct the development of PTG-200 through Phase II clinical proof-of-concept in Crohn’s disease, after which time Janssen will be responsible for development and commercialization. Per the terms of the agreement, Protagonist will have the right to co-detail PTG-200 in the United States. The agreement builds upon a Johnson & Johnson Innovation Series B venture financing from 2013 in support of the discovery and development of Protagonist’s pipeline of oral peptide therapeutics, the company said.
Protagonist’s investigative gut drug is expected to complement Janssen’s programs for treatment of IBD. On Janssen’s website, the company touts its history in treating gastrointestinal diseases and IBD.
“Since introducing the first tumor necrosis factor (TNF) inhibitor to the market in 1998 for the treatment of Crohn’s disease, changed the IBD treatment paradigm and remain focused in this disease area,” the company said.
“The funding provided by this transaction enables us to advance our platform and clinical pipeline of innovative peptide drugs, including our lead oral peptide alpha-4-beta-7 integrin antagonist, PTG-100, which is currently in a Phase IIb clinical trial as a potential treatment for ulcerative colitis,” Dinesh Patel, Protagonist’s president and chief executive officer said in a statement.
Investors, as expected, reacted positively, sending shares of Protagonist up more than 72 percent this morning. The stock is trading at $14.15 as of 9:30 a.m.
PTG-200 is not the only drug in Protagonist’s pipeline. Earlier this month the company initiated a Phase I study of PTG-300, an injectable hepcidin mimetic peptide, for the treatment of patients with chronic iron overload in rare diseases such as beta-thalassemia.
