Protagonist Therapeutics Achieves Success in Phase 3 Trials for Oral Plaque Psoriasis Treatment

Protagonist Therapeutics Achieves Success in Phase 3 Trials for Oral Plaque Psoriasis Treatment

Protagonist Therapeutics Achieves Success in Phase 3 Trials for Oral Plaque Psoriasis Treatment

The phase 3 ICONIC-LEAD study indicated that icotrokinra, a peptide drug targeting the interleukin (IL)-23 receptor, successfully led to substantial clearance of psoriatic plaques.

In partnership with Johnson & Johnson, Protagonist will receive 5 million as a milestone payment following the successful completion of the phase 3 study.

Previously, Protagonist had already secured million following the acceptance of a New Drug Application (NDA) for psoriasis, and an additional million after initiating a phase 3 trial for a second indication, accumulating total milestone payments to 5 million.

The IGA scale, employed to assess psoriasis severity, ranges from 0 to 4. In this study, it was revealed that 65% of participants achieved clear skin (with an IGA score of 0 or 1) by week 16, compared to merely 8% in the placebo cohort.

The PASI score assesses the area affected by psoriasis plaques and evaluates their severity. A PASI score of 90 or above indicates a 90% improvement from baseline, which was accomplished by 50% of the icotrokinra group, in contrast to only 4% of the placebo group.

Outcomes improved over time, with 74% of patients attaining clear skin and 65% achieving PASI90 by week 24. Approximately 49% of both the treatment and placebo groups experienced some form of adverse event, without an increase linked to icotrokinra administration.

“The positive phase 3 findings affirm the strong efficacy and safety patterns noted in earlier Phase 2b FRONTIER-1 and -2 trials, underscoring icotrokinra’s promise as a leading oral treatment providing a unique combination of notable skin clearance and proven tolerability with a once-daily dosage for plaque psoriasis,” stated Dinesh Patel, President and CEO of Protagonist.

“These outcomes further validate Protagonist’s pioneering peptide technology platform and its capability to develop highly differentiated new chemical entities to meet unmet clinical needs across varied disease domains.”

New solutions for a widespread skin condition

Psoriasis affects approximately 2-3% of the global population, constituting an autoimmune skin disorder where the body excessively generates skin cells triggered by events that incite the immune system.

In individuals with psoriasis, immune cells release inflammatory markers that prompt excessive production of keratinocytes, leading to the formation of characteristic plaques associated with plaque psoriasis, which represents 85-90% of affected individuals.

While there is no definitive cure for psoriasis, various treatments exist, ranging from topical options to systemic therapies. The most effective systemic treatments are often injectable, including monoclonal antibodies like infliximab or ustekinumab. Icotrokinra aims to match the efficacy of these injectable therapies through an oral formulation, minimizing invasiveness and enhancing patient compliance.

Bristol Myers Squibb’s established oral treatment, Sotyktu (deucravacitinib), which acts as a tyrosine kinase 2 (TYK2) inhibitor, was approved in 2022. Protagonist and J&J are looking to capture part of this market, with phase 3 trials currently assessing both drugs head-to-head.