A promising oral treatment for moderate to severe psoriasis, demonstrating efficacy akin to its injectable counterpart, moves closer to fruition with the initiation of a multi-centre international phase 3 clinical trial. Leading dermatologists in Australia have embarked on this pivotal trial to assess the safety and effectiveness of the oral interleukin-23–receptor antagonist peptide.
Professor Rod Sinclair, head of Sinclair Dermatology based in Melbourne, has commenced patient recruitment for the trial. Expressing optimism, he anticipates the drug could be accessible within three to four years pending favorable trial outcomes.
This development heralds potential benefits for patients averse to injections, as well as streamlined medication distribution and potential cost savings. Professor Sinclair remarked, “It’s a major breakthrough,” emphasizing the shift from injectables to tablets and its immediate and long-term implications for healthcare accessibility and sustainability.
Citing a study published in the New England Journal of Medicine, Professor Sinclair highlighted the superior efficacy of the oral interleukin-23 receptor antagonist peptide, referred to as JNJ-77242113, in patients with moderate to severe plaque psoriasis. The study demonstrated significant reduction in the Psoriasis Area and Severity Index (PASI) score, with a notable 79% of patients achieving at least a 75% reduction from baseline after 16 weeks of treatment.
Notably, adverse events were comparable between the treatment and placebo groups, with no evidence of a dose-related increase in adverse events, according to researchers.
The introduction of monoclonal antibodies has transformed the treatment landscape for immune-mediated inflammatory diseases such as psoriasis. IL-23, a key player in psoriasis pathogenesis, presents a prime target for therapeutic intervention. While existing biologic agents targeting IL-23 require intravenous or subcutaneous administration, the oral formulation of JNJ-77242113 offers a promising alternative, particularly for needle-averse patients.
Dr. John Frew, a staff specialist dermatologist at Sydney’s Liverpool Hospital and Conjoint Associate Professor at UNSW School of Clinical Medicine, expressed enthusiasm for the drug’s potential. He highlighted its comparable efficacy to existing biologic therapies and underscored the preference for oral medications among patients.
Moreover, Dr. Frew emphasized the convenience of oral medication, particularly for travel, as it eliminates the need for cold storage. He anticipates a significant impact on patient care and intends to participate in the upcoming clinical trials.
Professor Sinclair echoed these sentiments, emphasizing the potential benefits for rural and remote psoriasis patients in Australia. He underscored the simplified distribution logistics and anticipated cost reductions, which could enhance accessibility to treatment across the country.
As clinical trials progress, the efficacy and durability of the clinical response to JNJ-77242113 will be elucidated, offering hope for improved outcomes and enhanced accessibility for psoriasis patients worldwide.