Johnson & Johnson announces positive clinical trial results for plaque psoriasis treatment

Johnson & Johnson (J&J) announced results from the phase 3 investigational study of its targeted oral peptide icotrokinra for treating plaque psoriasis. Within six months of starting the treatment, the company reported that the majority of study subjects taking icotrokinra achieved clear or almost clear skin.

J&J said the positive topline outcomes of the trial were that 64.7% of study subjects who took icotrokinra as a daily oral pill achieved clear or almost clear skin after 16 weeks, increasing to 74.1% of patients by week 24. Icotrokinra is a development resulting from the collaboration between Protagonist Therapeutics and J&J’s Janssen Biotech.

Icotrokinra selectively blocks the IL-23 receptor, thus inhibiting inflammatory autoimmune responses in the body. Plaque psoriasis is an autoimmune condition causing dry and itchy patches of skin called plaques, which usually occur on the knees, elbows, scalp and lower back. Severe cases can affect the entire body.

“We are excited to see impressive phase 3 results with once-daily icotrokinra treatment aligned with our phase 2 study of this first-in-class targeted oral peptide that selectively blocks the IL-23 receptor,” says Liza O’Dowd, VP of J&J Innovative Medicine.

Promising treatment

The investigational study looked at the drug’s effect on moderate to severe plaque psoriasis in adults and adolescents (12 years and older). Two-thirds of the patients who took one daily icotrokinra showed significant skin clearance at week 16, compared to only 8.3% of those given the placebo. 

J&J reports that a similar proportion of patients in the treatment group and the placebo group experienced a “treatment emergent adverse event,” meaning an undesirable medical event that was either not present before the start of the study or something that worsened following the treatment. In the icotrokinra group, 49.3% experienced an adverse event compared to 49.1% in the placebo group. There is no cure for plaque psoriasis, only treatment.

“These positive phase 3 results confirm the compelling efficacy and safety trends that were observed with the previous phase 2b Frontier-1 and -2 studies, highlighting icotrokinra’s potential as a best-in-class oral agent providing an ideal combination of significant skin clearance with demonstrated tolerability in a once-daily pill for treating plaque psoriasis,” says Dr. Dinesh V. Patel, Protagonist Therapeutics president and CEO.

There is no cure for psoriasis but treatment can help alleviate it. The National Psoriasis Foundation says that 125 million people worldwide have psoriasis, which greatly affects the quality of life for those who have it. 

“The majority of people living with moderate-to-severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies. Icotrokinra has the potential to offer once-daily oral therapy that could help address the needs and preferences of people living with plaque psoriasis,” says O’Dowd.

Protagonist and J&J are jointly developing icotrokinra under a license and collaboration agreement, and J&J has exclusive rights to develop the drug beyond phase 2 trials. Icotrokinra is also being studied for treating other inflammatory conditions like ulcerative colitis which occurs in the large intestine. 

J&J in the news over talc powder

J&J was ordered to pay US$15 million to a Connecticut, US, resident who said he developed mesothelioma after using the company’s talc powder for decades. The plaintiff, Evan Plotkin, sued J&J in 2021 closely after his diagnosis, claiming that inhalation of J&J’s baby powder caused his cancer. 

The pharmaceutical company previously settled state consumer protection claims and talc-related claims in bankruptcy cases filed by its suppliers. The company still maintains that the claims pertaining to its talc are baseless, citing denials from specialists and authorities.

However, J&J withdrew its talc-based powder products from the US market in 2020. The company said it would halt sales of talc-based baby powder and transition to cornstarch-based baby powder to meet “evolving global trends.”

In June, Personal Care Insights reported on the company’s willingness to pay US$700 million to settle an investigation brought on by multiple US states. 

Keywords: Johnson & Johnson, Clinical Trial, Drug Development, Pharmaceuticals