Johnson & Johnson’s (J&J) Icotyde (icotrokinra) has been approved by the US FDA to treat moderate-to-severe plaque psoriasis (PsO) in both adults and paediatric patients.

Icotyde, an interleukin-23 (IL-23) receptor antagonist, is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. It’s been approved for adults and paediatric patients over the age of 12 who weigh at least 40kg and who are candidates for systemic therapy or phototherapy.

The ICONIC trials involved 2,500 patients and evaluated Icotyde in both adolescents and adults in high-impact sites like scalp and genital PsO.

When tested in head-to head superiority trials versus an active comparator, approximately 70% of patients achieved clear or almost clear skin and 55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response at week 16.

PsO is a chronic immune-mediated disease causing inflamed, scaly plaques that can be itchy or painful, with nearly a quarter of those with the affected having cases considered moderate to severe.

Psoriasis affects more than eight million people in the US and over 125 million worldwide, and can impact quality of life.

LEO Pharma has announced that it will acquire Replay, a gene therapy company focused on developing transformative treatments for rare genetic dermatological conditions. LEO will pay Replay $50m upfront, plus milestone payments and tiered single-digit royalties.

The acquisition adds deep expertise and a next-generation gene therapy platform to
LEO Pharma’s pipeline through Replay’s high-payload herpes simplex virus (HSV)
delivery vector.

Viral gene therapy uses engineered viruses to deliver therapeutic genetic material into cells to treat disease at its source. Replay’s gene therapy platform leverages HSV’s unique capacity to deliver large genes, making it particularly well suited for addressing rare, genetically driven dermatological conditions.

The genetically modified HSV therapy is formulated as a topical gel that targets the
deficient gene when applied directly to the skin.

The lead drug candidate in Replay’s pipeline is currently in preclinical studies
for the treatment of a rare genetic condition called dystrophic epidermolysis bullosa
(DEB). This condition causes the skin to be fragile and blister easily, leading to painful
chronic wounds that heal slowly and poorly, often resulting in scar tissue and skin
cancer.

Biogen’s AMETHYST phase 2/3 study (Part A) of litifilimab as a treatment for cutaneous lupus erythematosus (CLE) has shown positive results.

As the first humanised IgG1 monoclonal antibody (mAb) targeting blood dendritic
cell antigen 2 (BDCA2), litifilimab could become the first innovative CLE therapy
approved in 70 years.

Affecting millions of people around the world, CLE is a complex, heterogenous
disease with no approved targeted therapy treatments.

Previous results from the phase 2 LILAC and AMETHYST trials formed the
basis for the treatment’s recent US FDA Breakthrough Therapy Designation, with
the LILAC results published in The New England Journal of Medicine.

Currently ongoing, AMETHYST is a two-part, multicentre, randomised study
in which participants receive either subcutaneous treatment with litifilimab and
standard of care (SoC) or placebo every four weeks with SoC.

Tolerability was consistent with the safety profile, with Litifilimab being generally
well tolerated throughout part A of the AMETHYST study.

Of the patients receiving Litifilimab in the 24 week period, 74.6% experienced
adverse events (AEs) compared to 64.7% of those receiving placebo.