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Protagonist (PTGX) Begins Dosing in Phase I Study With PN-235

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Protagonist Therapeutics, Inc. (PTGX - Free Report) announced that it has dosed the first patient in a phase I study, evaluating its oral interleukin-23 receptor (IL-23R) antagonist peptide – PN-235 (also known as JNJ-77242113).

The early-stage study is being conducted as a part of Protagonist Therapeutics’ ongoing collaboration with Janssen Biotech, Inc., a wholly owned subsidiary of Johnson & Johnson (JNJ - Free Report) .

Per the company, PN-235 was discovered through Protagonist Therapeutics’ peptide technology platform and is the first second-generation oral IL-23 receptor antagonist to enter clinical development. The phase I study will evaluate the safety, tolerability and pharmacokinetics of oral PN-235 in around 100 healthy volunteers. The company remains focused to see its potential for multiple indications targeting the well-validated IL-23 pathway. Results from the phase I study are expected in 2021.

Shares of Protagonist Therapeutics were up 9.9%, following the announcement of the news on Wednesday. In fact, the stock has skyrocketed 207.9% so far this year compared with the industry’s increase of 9.2%.

price chart for PTGX


The phase I study on PN-235 will be categorized in three parts, namely – a single ascending dose, a multiple ascending dose and a randomized, crossover solid dose comparison part. The primary endpoint of the study will check the safety as measured by the number and severity of adverse events.

Notably, Protagonist Therapeutics has a co-development and commercialization agreement with Janssen for IL-23 receptor-targeted therapies targeting various indications. Per the agreement, Protagonist Therapeutics will be eligible to receive development and sales-based milestone payments if a product is commercialized from the collaboration. Janssen, on the other hand, will lead further development/commercialization activities of candidates beyond the phase II study.

We remind investors that Protagonist Therapeutics and Janssen Biotech are currently evaluating PTG-200, an oral IL-23 receptor antagonist, in a phase II study for the treatment of Crohn's disease.

Protagonist Therapeutics is also evaluating the safety, tolerability and efficacy of PN-943, an oral alpha-4-beta-7 integrin antagonist, in a phase II study for treating moderate-to-severe ulcerative colitis.

Zacks Rank & Stocks to Consider

Protagonist Therapeutics currently carries a Zacks Rank #2 (Buy). Some other stocks to consider in the biotech sector include Halozyme Therapeutics, Inc. (HALO - Free Report) and Cara Therapeutics, Inc. (CARA - Free Report) , both  carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Halozyme’s earnings estimates have moved 31.4% and 19.4% north for 2020 and 2021, respectively, over the past 60 days. The stock has rallied 131.9% year to date.

Cara Therapeutics’ loss per share estimate has been narrowed 14.2% for 2020 and 22.5% for 2021 over the past 60 days.

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