{"id":64290,"date":"2023-09-22T15:54:45","date_gmt":"2023-09-22T19:54:45","guid":{"rendered":"https:\/\/ifintechworld.com\/news\/protagonist-therapeutics-there-are-reasons-behind-johnson-johnsons-optimism-ptgx\/"},"modified":"2023-09-22T15:54:48","modified_gmt":"2023-09-22T19:54:48","slug":"protagonist-therapeutics-there-are-reasons-behind-johnson-johnsons-optimism-ptgx","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=64290","title":{"rendered":"Protagonist Therapeutics: There Are Reasons Behind Johnson & Johnson’s Optimism (PTGX)"},"content":{"rendered":"
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Protagonist Therapeutics, Inc.<\/strong> (NASDAQ:PTGX<\/span>) is developing JNJ-2113 (PN-235), an oral IL-23 drug targeting psoriasis, however partner Johnson & Johnson (JNJ) says that until the oral drug can show non-inferior efficacy to J&J’s own injectable anti-IL-23 drug Tremfya, there is no point in developing it further.<\/span><\/p>\n

In April, Protagonist went up considerably after PN-235 showed a superior efficacy profile over other approved oral psoriasis drugs. However, in June, the stock was down again after PN-235 failed to beat Tremfya in a cross-trial comparison. That is, roughly, the Protagonist story.<\/p>\n

2113 is the only oral IL-23 targeting molecule in development. Other companies have oral versions of other immunotherapies, like Dice which has an IL-17 inhibitor, and Morphic which has an \u03b14\u03b27 integrin inhibitor. However, if 2113 fails to deliver, it will be joining a long list of other JNJ projects that Protagonist tested but abandoned.<\/span><\/p>\n

The March data was from the phase 2 FRONTIER 1 trial. There were 255 patients with moderate-to-severe plaque psoriasis who were administered three once-daily and two twice-daily dosages. Here\u2019s the efficacy and safety data from Seeking Alpha:<\/p>\n

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FRONTIER 1 reached the primary endpoint as a \u201cstatistically significant greater proportion of patients\u201d across all five JNJ-2113 groups indicated a 75% improvement in skin lesions at Week 16 as measured by the Psoriasis Area and Severity Index (PASI 75).<\/p>\n<\/blockquote>\n

According to the company, there was no \u201cmeaningful difference\u201d in the incidence of adverse events between the treatment and placebo arms of the trial.<\/p>\n

More complete data from this trial comparing 2113 with placebo is as follows:<\/p>\n

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At W16, the proportions of patients achieving PASI75 were PBO 9.3%, JNJ-77242113: 25mg QD 37.2%, 50mg QD 58.1%, 25mg BID 51.2%, 100mg QD 65.1%, 100mg BID 78.6%, demonstrating significant dose response. PASI90 response rates were PBO 2.3%, JNJ-77242113: 25mg QD 25.6%, 50mg QD 51.2%, 25mg BID 26.8%, 100mg QD 46.5%, 100mg BID 59.5%. PASI75 and PASI90 response rates for all JNJ-77242113 doses were significantly higher than PBO (nominal p \u22640.002 for all comparisons). The proportions of patients with adverse events (AES’) were comparable between JNJ-77242113 groups and the PBO group. Most frequently reported AEs were COVID-19 and nasopharyngitis with no dose-dependent trends.<\/p>\n<\/blockquote>\n

Now, if we put the complete data presented in July, here\u2019s what we get:<\/p>\n

<\/span><\/p>\n\n\n\n\n\n\n<\/colgroup>\n\n\n\n\n\n\n\n
\n

#<\/p>\n<\/td>\n

\n

Cohort<\/p>\n<\/td>\n

\n

PASI 75 (%)<\/p>\n<\/td>\n

\n

PASI 90 (%)<\/p>\n<\/td>\n

\n

PASI 100 (%)<\/p>\n<\/td>\n<\/tr>\n

\n

1<\/p>\n<\/td>\n

\n

25 mg daily (n=43)<\/p>\n<\/td>\n

\n

37.2<\/p>\n<\/td>\n

\n

25.6<\/p>\n<\/td>\n

\n

11.6<\/p>\n<\/td>\n<\/tr>\n

\n

2<\/p>\n<\/td>\n

\n

25 mg twice daily (n=41)<\/p>\n<\/td>\n

\n

51.2<\/p>\n<\/td>\n

\n

26.8<\/p>\n<\/td>\n

\n

9.8<\/p>\n<\/td>\n<\/tr>\n

\n

3<\/p>\n<\/td>\n

\n

50 mg daily (n=43)<\/p>\n<\/td>\n

\n

58.1<\/p>\n<\/td>\n

\n

51.2<\/p>\n<\/td>\n

\n

25.6<\/p>\n<\/td>\n<\/tr>\n

\n

4<\/p>\n<\/td>\n

\n

100 mg daily (n=43)<\/p>\n<\/td>\n

\n

65.1<\/p>\n<\/td>\n

\n

46.5<\/p>\n<\/td>\n

\n

23.3<\/p>\n<\/td>\n<\/tr>\n

\n

5<\/p>\n<\/td>\n

\n

100 mg twice daily (n=42)<\/p>\n<\/td>\n

\n

78.6<\/p>\n<\/td>\n

\n

59.5<\/p>\n<\/td>\n

\n

40.5<\/p>\n<\/td>\n<\/tr>\n

\n

6<\/p>\n<\/td>\n

\n

Placebo<\/p>\n<\/td>\n

\n

9.3<\/p>\n<\/td>\n

\n

2.3<\/p>\n<\/td>\n

\n

0.0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

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