Almirall : Tildrakizumab demonstrates lasting efficacy and safety through 3 years

Paris (France),
17th September 2018

Almirall, S.A. (ALM) today announced the results of a pooled analysis through 3 years¹ from reSURFACE 1 and reSURFACE 2 phase III trials³, that shows the consistent maintenance of efficacy and safety over three years of tildrakizumab in patients with moderate-to-severe chronic plaque psoriasis who were responders at week 28. The analysis has been presented in the Late Breaking News Session on Saturday, 15^th September at the 27^th European Academy of Dermatology and Venerology (EADV) Congress, held in Paris (France).

Tildrakizumab is a humanized high-affinity anti-IL-23p19 monoclonal antibody.²Due to its specific mechanism of action, it selectively blocks interleukin-23 (IL-23), an upstream inflammatory mediator cytokine, and acts by modifying the pathogenesis of the disease with limited impact on the rest of the immune system.

Dr. Diamant Thaçi, Professor and Head of the Comprehensive Center for Inflammation Medicine at the University of Lübeck (Germany), and main author of the analysis said: 'The objective was to report preliminary 148-week pooled efficacy and safety results in responders (PASI ≥75%) at week 28 from reSURFACE 1 and reSURFACE 2 who continued treatment with the same dose of tildrakizumab. The results have shown the lasting efficacy and safety of tildrakizumab with just 4 doses per year during maintenance period. Its convenient dosing regimen also results in a positive impact on patients' quality of life and encourages adherence achieving a better control over the long term'.

According to the data, efficacy with tildrakizumab was maintained for nearly 3 years. PASI 75 responses were maintained with continued treatment with tildrakizumab in 9 out of 10 patients up to week 148.¹More than 50% of patients reported that psoriasis no longer affected their lives after only 3 doses.^2,3Tildrakizumab was well-tolerated with very low drug-related serious adverse events and discontinuation rates.

With only 4 doses per year during maintenance, tildrakizumab offers an easy and convenient dosing regimen.²

About reSURFACE 1/2

ReSURFACE 1 (64 weeks) and reSURFACE 2 (52 weeks)³included over 1,800 patients from more than 200 clinical sites worldwide, and its positive results were presented for the first time at the 25^th European Academy of Dermatology and Venerology (EADV) Congress. According to their data, at week 28, 329 patients who were responders to tildrakizumab 100 mg and 227 patients who were responders to tildrakizumab 200 mg continued with the same dose. And at week 52, after 5 doses of tildrakizumab, 91.2% of patients with 100 mg of tildrakizumab maintained PASI 75 and 73.2% has PASI 90 responses, while 94% of patients with 200 mg of tildrakizumab maintained PASI 75 and 75.6% maintained PASI 90 responses.¹

Patients who completed both clinical trials achieving at least PASI 50 entered an optional extension period up to 192 weeks (patients from reSURFACE 1) and 244 weeks (patients from reSURFACE 2). Safety analysis included pooled data across trials (continuous exposure to tildrakizumab 200 mg or 100 mg).¹

The results shown that during the 2-year extension period, responses were maintained. At week 148, 91.2% of patients with 100 mg of tildrakizumab maintained PASI 75 and 67.6% had PASI 90 responses. For their part, 92.4% of patients with 200 mg of tildrakizumab maintained PASI 75 and 69% has PASI 90 responses.¹

About tildrakizumab

Tildrakizumab is a humanized monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23) and inhibits the release of proinflammatory cytokines and chemokines with limited impact on the rest of the immune system.² Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates to systemic therapy, in phase 3 studies³ it has been shown that provide change that lasts through its long-term efficacy, safety and convenient dosing regimen. Its lower frequency of injections -only 4 doses per year during maintenance- results in convenience and quality of life for patients encouraging adherence.

Almirall in-licensed tildrakizumab from Sun Pharmaceutical Industries Ltd. (Sun Pharma) in July 2016. The agreement is for development and commercialization of tildrakizumab in Europe.

Sun Pharma got approval for tildrakizumab from the US FDA in March this year for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In July 2018, tildrakizumab received the CHMP positive opinion for its marketing in Europe.

About Psoriasis

Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.8 million adults in Europe and approximately 125 million people worldwide.⁴It is a non-contagious disorder that accelerates the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite different treatment options existing, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.

About Almirall

Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients & future generations. Our efforts are focused on fighting against skin health diseases and helping people feel and look their best. We support healthcare professionals in its continuous improvement, bringing our innovative solutions where they are needed.

The company, founded 75 years ago and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment with its major shareholders and its decision to help others, to understand their challenges and to use Science to provide them with solutions for real life. Total revenues in 2017 were 755.8 million euros. More than 1,830 employees are devoted to Science.

For more information, please visit almirall.com linkedin.com/company/almirall

References

1. Thaçi D, Iversen L, Pau-Charles I, Rozzo S, Blauvelt A, Reich K. Long-term efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who were responders at week 28: pooled analysis through 3 years (148 weeks) from reSURFACE 1 and reSURFACE 2 phase 3 trials. EADV 2018
2. ILUMETRI® Summary of Product Characteristics
3. Reich K, et al. Tildrakizumab, selective IL-23p19 antibody, in the treatment of chronic plaque psoriasis: results from two randomized, controlled, Phase 3 trials (resurface 1 and reSURFACE 2) [abstract]. Presented as a late breaking abstract at the European Academy of Dermatology and Venereology 2016. October 1, 2016.
4. Greb JE, Goldminz AM, Elder JT, et al. Psoriasis. Nat Rev Dis Primers. 2016;2:16082.