Sun Pharmaceutical Industries has on Friday announced that one of its wholly owned subsidiaries presented new clinical insights on psoriasis drug tildrakizumab-asmn (branded as Ilumya) at the 2019 American Academy of Dermatology (AAD) Annual Meeting, including long-term data showing sustained skin clearance in some patients living with moderate-to-severe plaque psoriasis after three years of ongoing treatment with Ilumya .
Ilumya is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Sun Pharma and Merck & Co had in 2014 signed an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate tildrakizumab, which was then being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis. Under this agreement, Sun Pharma was to acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80 million.
While Merck continue all clinical development and regulatory activities, which were funded by Sun Pharma. Upon product approval, Sun Pharma was responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties on sales.
The Friday statement said that the US FDA approval is based on data from the pivotal Phase-3 reSURFACE clinical development program, which consisted of two randomized, double-blind, placebo-controlled trials of more than 1,800 patients across over 200 clinical trial sites. The drug has been approved in Australia and Europe under the brand name ILUMETRI.
These findings from the Phase 3 reSURFACE 1 and reSURFACE 2 studies showed sustained response by some patients over time and Ilumya was well tolerated with low rates of adverse events. After up to 5 years of treatment, all prespecified adverse events were reported at rates <1.6 and <1.3 events per 100 patient-years in reSURFACE 1 and reSURFACE 2, respectively. Of the adverse events of interest, severe infections (1.2 and 1.5 events per 100 patient-years, respectively) and malignancies (1.2 and 0.5 events per 100 patient-years, respectively) were the most frequently reported.
The US FDA approval of Ilumya for adults with moderate-to-severe plaque psoriasis, who are candidates for systemic or phototherapy, is based on 64-week and 52-week reSURFACE data.
Dr. Andrew Blauvelt, board-certified dermatologist and President of Oregon Medical Research Center was quoted in a press statement by Sun pharma on Friday that; “It’s very encouraging to see these effective response rates with Ilumya over a three-year period, because as clinicians we’re often faced with the challenge of finding the right treatment that addresses the chronic nature of plaque psoriasis. We’re also starting to learn more about which patients Ilumya may be a fit for,”
“In a one-year analysis we saw that Ilumya showed similar results of skin clearance in both patients who were new to biologic therapy and those who had previously been treated with another biologic. Furthermore, with its HCP administration model Ilumya supports treatment adherence and may be a good treatment option for patients who are starting their first biologic treatment or those who have failed previous therapy.”
Results from bio-naïve and bio-experienced patients showed that treatment with Ilumya achieved a PASI ≥50 response at Week 28 and was maintained or continued to increase at Week 52, regardless of the patient’s previous exposure to biologic treatment.3
Furthermore, additional one-year data analyses presented during the 2019 AAD Annual Meeting show that Ilumya is similarly effective and safe for moderate-to-severe plaque psoriasis patients who have the common condition metabolic syndrome and those who do not. People with psoriasis are predisposed to metabolic syndrome, and psoriasis has been shown to increase the prevalence of metabolic syndrome by three-fold.
Patients with moderate-to-severe plaque psoriasis treated with Ilumya 100 mg who achieved PASI 75 at Week 52 were comparable between those with metabolic syndrome (84% [0.04]) and without (90% [0.02]) and reported similar adverse events, with no reports of cardiovascular events or diabetes worsening by metabolic syndrome status.4,5 The most common treatment-emergent adverse event was infection, occurring in 50.6% [n=40] of patients with metabolic syndrome and 53.1% [n=154] of patients without. The most commonly reported serious adverse events (>1.5% of patients with ≥1 SAE) in patients with metabolic syndrome were gastrointestinal and cardiac disorders.
“As we expand our knowledge and understanding of the potential Ilumya has for different patients, we’re excited to see the clinically meaningful benefits this treatment option may continue to offer,” said Abhay Gandhi, President and Chief Executive Officer, Sun Pharmaceutical Industries, Inc, the US unit of Sun Pharma.
“These insights are promising news for patients and clinicians, and we’re committed to helping those with moderate-to-severe psoriasis for whom Ilumya may be a good treatment option, ” he added in the press statement.
Additional analyses presented on Friday used the 10-year Markov model to demonstrate the cost-effectiveness of Ilumya as a first-line treatment. The data results demonstrated that Ilumya is among the most cost-effective options compared to other biologic options including secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab, and etanercept.
Psoriasis is a chronic immune disease that appears on the skin, affecting approximately 8 million Americans and 125 million people worldwide. The non-contagious disorder speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form, affecting about 80 to 90% of people with psoriasis, is called plaque psoriasis. It appears as red, raised areas of skin covered with flaky white scales which may be itchy and painful and can crack and bleed. 20% of people with plaque psoriasis are considered moderate-to-severe, and many continue to struggle with the ongoing, persistent nature of this chronic disease