J&J and Protagonist Therapeutics Move Oral Psoriasis Drug to Phase 3 Trial

J&J shared results from its phase 2 trial for JNJ-2113, an oral psoriasis drug focused on targeting an inflammatory protein, IL-23. Results from the trial were shared at the World Congress of Dermatology in Singapore.

In 2017, a collaboration agreement between Johnson and Johnson subsidiary Janssen and Protagonist Therapeutics was signed for the drug, where the former was responsible for the commercialization of the drug licensed from the latter. The aim of the pill is to act as a replacement for injectable medicines in the market for the disease, such as Tremfya and Stelara.

The phase 2b trial in question enrolled over 250 participants who randomly either received a placebo or one of the 5 different regimens of J&J’s drug. After following patients for 16 weeks, it was revealed that 58% of the patients who received a daily dose of 50mg experienced an approximate 75% reduction in PASI scores. Over 50% of the participants in the trial showed a 90% improvement in their condition.

In the case of participants who were given a once-daily, 100 mg dose, a 75% improvement was observed in around 65% of them. Over 20% of the participants in the group also observed complete skin clearance, and in the case of over 45% of the participants, a 90% reduction was seen.

The efficacy of drugs used for the treatment of psoriasis is measured by the use of the Psoriasis Area and Severity Index (PASI) scores. The scores are used to mark improvements in symptoms such as discoloration, thickness, and coverage of the skin plaques that come with being affected by the chronic disease.

Although JNJ-2113 performed better than a placebo in all cases, when compared to the injectable Tremfya, the results were disappointing for investors. The drug has a reported success rate of 3% to 91% and 70% to 73% of patients for 75% improvement in skin lesions and 90% improvement in skin lesions, respectively.

As a result, when summary results from the trial were first disclosed, it led to a fall of more than 30% in the shares of Protagonist. Initially, an increase of nearly 8% was observed in the shares of the firm at the time of publication, but this had been attributed to limited efficacy details disclosed in the abstract, according to Jefferies analysts. While Protagonist’s shares fell to a third of their value, they recovered a little to eventually finish down 20%.

J&J had previously stated that in order to justify the continued development of the drug, it would have to show comparable results to injectable anti-IL-23 psoriasis equivalents. Despite failing to do so, the company has decided to proceed to a phase 3 trial.

An overall shift in the industry from injectable biologics to pills has started so that the efficacy of injectables and the convenience of pills can be combined when treating autoimmune diseases. Eli Lilly’s acquisition of Dice Therapeutics last month was aimed at such.

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