J&J to Take Protagonist-Licensed Oral Psoriasis Drug to Phase III

Pictured: J&J sign/courtesy of Cristina Arias/Getty Images

Pictured: J&J sign/courtesy of Cristina Arias/Getty Images

After shares of Protagonist Therapeutics crashed 20% Monday following the presentation of data from JNJ-2113—which J&J licensed from the biotech—subsidiary Janssen confirmed it will advance the oral psoriasis drug to Phase III.

Protagonist’s shares shed a third of their value but recovered to finish Monday down around 20% after data from a Phase IIb clinical study presented at the World Congress of Dermatology in Singapore showed the drug did not appear to be as effective as Janssen’s Stelara and Tremfya or AbbVie’s Skyrizi.

However, Janssen on Tuesday released fuller data showing that JNJ-2113 hit its primary and secondary endpoints, besting placebo when measuring 75%, 90% and 100% improvements in skin lesions after 16 weeks of treatment. At the highest dose—100 mg twice daily—78.6% of patients achieved 75% clearance. Meanwhile, 100 mg twice a day of JNJ-2113 led to 59.5% of patients achieving 90% clearance; 40.5% of patients achieved 100% lesion clearance when dosed at 100 mg twice per day. All values beat the placebo.

The 59.5% who reached 90% still pales in comparison to Skyrizi, which elicited a 75% on this measurement, according to its prescribing label.

Protagonist’s shares were up nearly 8% at the time of publication. In a Tuesday note to investors, Jefferies analysts said they believe Monday’s stock reaction was “an overreaction” based on the limited efficacy details disclosed in the abstract. “The overall data was strong on both efficacy and safety for an oral therapy that will likely be the first oral agent targeting the IL-23 pathway that’s highly regarded by physicians,” they wrote.

Original Story Published July 3

J&J’s Protagonist-Licensed Psoriasis Drug Falls Short in Phase II Trial 

JNJ-2113, an oral psoriasis drug licensed from Protagonist Therapeutics and planned to be commercialized by Johnson & Johnson’s Janssen Biotech, is not as effective as some of its injectable competitors, according to the results of a Phase IIb clinical study shared Monday as an abstract at the World Congress of Dermatology in Singapore.

Protagonist’s shares dropped a third of their value Monday morning following the publication of the abstract, although a few hours later they slightly recovered resulting in a loss of around 20% in the stock’s price.

In July 2021, Protagonist and Janssen started the collaboration agreement on JNJ-2113 in which J&J retained exclusive worldwide rights to development in Phase II and beyond and to commercialize derived compounds. In that agreement, Protagonist became eligible to receive approximately $900 million in future development and sales milestones. It is unclear whether the results posted Monday will affect J&J’s decision to continue investing in the development of the oral drug.

The oral IL-23 receptor antagonist JNJ-2113, formerly known as PN-235, showed significantly greater efficacy than a placebo treatment and Monday’s data suggest no significant adverse effects. However, the numbers fell short of expectations. J&J had previously stated that JNJ-2113 would have to be at least as effective as its injectable anti-IL-23 psoriasis equivalent, Tremfya, to continue to justify its development—but it didn’t.

The efficacy of psoriasis drugs is often measured by the Psoriasis Area and Severity Index (PASI) scores, which assess improvements of the chronic disease in terms of discoloration, thickness, and coverage of the skin plaques associated with it. When measuring PASI 75 (75% of improvements in skin lesions) after 16 weeks of treatment in the FRONTIER 1 trial, JNJ-2113 resulted in 78.6% of patients getting the maximum dose (100 mg twice daily), while 59.5% of patients of that same group achieved a 90% improvement (PASI 90).

In comparison, the injectable Tremfya had reported success for 83% to 91% and 70% to 73% of patients for PASI 75 and PASI 90, respectively. Skyrizi, another psoriasis drug targeting IL-23, commercialized by AbbVie, has also reported 72% to 75% values for the PASI 90 score.

In May, Protagonist reported positive results for this same drug in animal models and a Phase I trial, where its ability to inhibit the IL-23 pathway—key in inflammatory skin diseases—was demonstrated.

Shortly after those earlier results, Protagonist CEO Dinesh Patel declared the potential of JNJ-2113 as a “first-in-class” drug candidate, representing “a major breakthrough in the field of innovative oral peptide-based therapeutics.” Patel added that the team looked forward to the Phase IIb results, aimed to assess the efficacy and safety of the drug in adults with moderate-to-severe plaque psoriasis.

However, with the FRONTIER 1 trial results showing that JNJ-77242113's efficacy was not as good as IL-23 biologics, Protagonist investors on Monday were clearly disappointed.

Alejandra Manjarrez is a freelance science writer based in Mexico City. Reach her on her website.

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