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Protagonist (PTGX) Up on Positive Results From FRONTIER Study
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Shares of Protagonist Therapeutics, Inc. (PTGX - Free Report) surged 51.91% on Mar 7 after the company announced positive top line results from FRONTIER 1 study of the oral IL-23 receptor antagonist JNJ-2113 (formerly PN-235) in psoriasis in collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ - Free Report) .
The randomized, multicenter, double-blind, placebo-controlled study FRONTIER 1 phase IIb trial (NCT05223868) is evaluating the efficacy and safety of JNJ-2113 in patients with moderate-to-severe plaque psoriasis. It evaluated three once-daily dosages and two twice-daily dosages of JNJ-2113 taken orally. The primary endpoint of the study is the proportion of patients achieving PASI-75 at 16 weeks.
Data from the study showed that JNJ-2113 achieved the study's primary efficacy endpoint with a statistically significant greater proportion of patients who received JNJ-2113 achieving PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) responses compared to placebo at week 16 in all five treatment groups.
Protagonist expects that JNJ-2113 will progress into a phase III registrational study in plaque psoriasis on the strength of these data.
JNJ-2113 was discovered by Protagonist and is being developed by Janssen Biotech, Inc., pursuant to the license and collaboration agreement between Protagonist and Janssen. Protagonist completed a phase I study of JNJ-2113 in healthy volunteers in October 2021. Janssen retains exclusive, worldwide rights to develop the compound in phase II and beyond as well as to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.
If JNJ-2113 advances into a phase III study and the study meets its primary goal, Protagonist is entitled to get milestone payments of $50 million and $115 million, respectively. In total, Protagonist remains eligible for up to $855 million in various milestone payments and tiered royalties based on worldwide net drug sales.
Hence, the successful development of the candidate will be a big boost for the company.
The company’s shares have lost 9.1% in the past year compared to the industry’s decline of 10.2%.
Image Source: Zacks Investment Research
JNJ-2113 is currently being studied in multiple trials, also led by Johnson & Johnson’s Janssen. FRONTIER 2 is a long-term extension study of JNJ-2113 in adults with moderate to severe plaque psoriasis; the SUMMIT phase IIa study is assessing a delayed-release JNJ-2113 tablet versus placebo in adults with moderate to severe plaque psoriasis and a phase I study of an immediate-release formulation of JNJ-2113 in healthy and adult Chinese participants is currently recruiting.
Meanwhile, Protagonist’s lead candidate, rusfertide, a mimetic of the natural hormone hepcidin, is currently in phase III. The phase III VERIFY and phase II REVIVE studies of rusfertide in polycythemia vera are ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.
AMRN’s loss estimates have widened by 3 cents to 12 cents for 2023 in the past 30 days. Amarin surpassed earnings estimates in two of the trailing four quarters and missed in the remaining two, with the average negative earnings surprise being 14.29%.
GERN’s loss estimates for 2022 have narrowed by 2 cents to 36 cents and by 4 cents to 32 cents for 2023 in the past 30 days. Geron surpassed earnings estimates in two of the trailing four quarters and missed in the remaining two, with the average earnings surprise being 1.07%.
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Protagonist (PTGX) Up on Positive Results From FRONTIER Study
Shares of Protagonist Therapeutics, Inc. (PTGX - Free Report) surged 51.91% on Mar 7 after the company announced positive top line results from FRONTIER 1 study of the oral IL-23 receptor antagonist JNJ-2113 (formerly PN-235) in psoriasis in collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ - Free Report) .
The randomized, multicenter, double-blind, placebo-controlled study FRONTIER 1 phase IIb trial (NCT05223868) is evaluating the efficacy and safety of JNJ-2113 in patients with moderate-to-severe plaque psoriasis. It evaluated three once-daily dosages and two twice-daily dosages of JNJ-2113 taken orally. The primary endpoint of the study is the proportion of patients achieving PASI-75 at 16 weeks.
Data from the study showed that JNJ-2113 achieved the study's primary efficacy endpoint with a statistically significant greater proportion of patients who received JNJ-2113 achieving PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) responses compared to placebo at week 16 in all five treatment groups.
Protagonist expects that JNJ-2113 will progress into a phase III registrational study in plaque psoriasis on the strength of these data.
JNJ-2113 was discovered by Protagonist and is being developed by Janssen Biotech, Inc., pursuant to the license and collaboration agreement between Protagonist and Janssen. Protagonist completed a phase I study of JNJ-2113 in healthy volunteers in October 2021. Janssen retains exclusive, worldwide rights to develop the compound in phase II and beyond as well as to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.
If JNJ-2113 advances into a phase III study and the study meets its primary goal, Protagonist is entitled to get milestone payments of $50 million and $115 million, respectively. In total, Protagonist remains eligible for up to $855 million in various milestone payments and tiered royalties based on worldwide net drug sales.
Hence, the successful development of the candidate will be a big boost for the company.
The company’s shares have lost 9.1% in the past year compared to the industry’s decline of 10.2%.
Image Source: Zacks Investment Research
JNJ-2113 is currently being studied in multiple trials, also led by Johnson & Johnson’s Janssen. FRONTIER 2 is a long-term extension study of JNJ-2113 in adults with moderate to severe plaque psoriasis; the SUMMIT phase IIa study is assessing a delayed-release JNJ-2113 tablet versus placebo in adults with moderate to severe plaque psoriasis and a phase I study of an immediate-release formulation of JNJ-2113 in healthy and adult Chinese participants is currently recruiting.
Meanwhile, Protagonist’s lead candidate, rusfertide, a mimetic of the natural hormone hepcidin, is currently in phase III. The phase III VERIFY and phase II REVIVE studies of rusfertide in polycythemia vera are ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.
Zacks Rank & Stocks to Consider
Protagonist currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Amarin (AMRN - Free Report) and Geron (GERN - Free Report) , both currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AMRN’s loss estimates have widened by 3 cents to 12 cents for 2023 in the past 30 days. Amarin surpassed earnings estimates in two of the trailing four quarters and missed in the remaining two, with the average negative earnings surprise being 14.29%.
GERN’s loss estimates for 2022 have narrowed by 2 cents to 36 cents and by 4 cents to 32 cents for 2023 in the past 30 days. Geron surpassed earnings estimates in two of the trailing four quarters and missed in the remaining two, with the average earnings surprise being 1.07%.