Advertisement

Topics

Ixekizumab (Taltz) - Biotech, Pharma and Life Science Channel

00:59 EDT 16th July 2018 | BioPortfolio

Ixekizumab (Taltz) is a humanised IgG4 monoclonal antibody that selectively binds with high affinity to the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.iii IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses, and elevated levels of IL-17A have been implicated in the pathogenesis of a variety of autoimmune diseases such as psoriasis.iii  Neutralisation of IL-17A by ixekizumab inhibits these pro-inflammatory actions.iii

Ixekizumab is administered by subcutaneous injection, either via auto-injector or prefilled syringe.iii

In UNCOVER-1 the results show that when treated every two weeks with ixekizumab for 12 weeks following a starting dose, approximately 9 of 10 patients achieved a PASI 75 score.iiiIn both UNCOVER-2 and UNCOVER-3 etanercept was used as an active comparator. The results show that approximately 9 of 10 patients treated with ixekizumab every two weeks achieved a PASI 75 score at week 12, and approximately 8 of 10 patients achieved clear or almost clear skin as defined by sPGA 0 or 1 respectively.iii,

Numerous secondary end points were also collected from the UNCOVER series of trials, including higher levels of clearance, (PASI 90, 100 and sPGA 0). The impact of psoriasis on patient's lives was assessed using patient reported outcome measures, including the DLQI. Across UNCOVER-1 and UNCOVER 2&3, 35.3 percent and 39 percent of patients, respectively achieved PASI 100 (clear skin) after 12 weeks of treatment with ixekizumab.iii

The approved dosing regimen for ixekizumab is a 160-mg starting dose by subcutaneous injection (two 80-mg injections) at Week 0, followed by 80 mg (one injection) every two weeks through 12 weeks, then maintenance dosing of 80 mg (one injection) every four weeks.iii

Lilly received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on February 25, 2016.v

Safety information

The very common (≥1/10 patients) adverse events in clinical trials were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).iii

About the UNCOVER Studies

The UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies are double-blind, multicentre, Phase III studies evaluating more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries.iii

All three studies evaluated the safety and efficacy of different dosing regimens of ixekizumab (80 mg every two or four weeks, following a 160-mg starting dose) compared to placebo after 12 weeks.iii

·       UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.iv

·       UNCOVER-1, UNCOVER-2 and UNCOVER-3 also evaluated response rates with ixekizumab during the maintenance period through 60 weeks, with UNCOVER-1 and UNCOVER-2 employing a randomized withdrawal design.iii,iv

·       In these studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0 or 1.iiiPASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician’s assessment of severity of a patient’s psoriasis lesions overall at a specific point in time.vi Both assessment tools (PASI and sPGA) are in line with CHMP guidelines to assess the effectiveness of treatments for psoriasis.vii

 

News Articles [72 Associated News Articles listed on BioPortfolio]

Innovation Pharmaceuticals Announces Database Lock for Phase 2b Trial of Oral Prurisol for Psoriasis

BEVERLY, Mass., June 29, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces database lock for its Phas...

Novartis Clear about Psoriasis survey data highlights challenges psoriasis patients face to achieve goal of clear skin

Novartis International AG / Novartis Clear about Psoriasis survey data highlights challenges psoriasis patients face to achieve goal of clear skin . Processed and transmitted by Nasdaq Corporate Sol...

Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center

New Biologicals Development Center in Biberach, Germany bundles biologics development, increases capacity and expands clinical supply network In...

Psoriasis Treatments to Become Cheaper as Biosimilars Compete in $5 Billion U.S. Psoriasis Drugs Market – New Study by iData Research

A new study by iData Research estimates that there are nearly 150,000 new cases of psoriasis (PsO) every year in the United States, affecting 2.2% of the population. Approx...

Janssen’s Tremfya®▼ (guselkumab) receives its first two positive Health Technology Assessments in Europe

The United Kingdom’s National Institute for Health and Care Excellence (NICE) publishes positive guidance for the first selective interleukin (IL)-23 inhibitor to t...

Novartis presents data to advance understanding of the role of IL-17A and reinforce Cosentyx® leadership in spondyloarthritis

Novartis International AG / Novartis presents data to advance understanding of the role of IL-17A and reinforce Cosentyx® leadership in spondyloarthritis . Processed and transmitted by Nasdaq Corp...

Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Revision: 5, Authorised

Zai Lab and Crescendo Biologics Enter Exclusive Worldwide License Agreement for Innovative Protein Therapeutics for Inflammatory Indications

       Candidate to expand Zai Lab’s early-stage R&D programs, with an anticipated IND Filing for clinical studies in psoriasis in 2019 Shanghai, and Cambridge, UK,...

Sienna Biopharmaceuticals to Present SNA-125 Pre-Clinical Psoriasis Data as Late-Breaker at the International Investigative Dermatology Congress

WESTLAKE VILLAGE, Calif., May 16, 2018 (GLOBE NEWSWIRE) -- Sienna Biopharmaceuticals, Inc. (NASDAQ:SNNA) today announced that pre-clinical data from the Company’s topical product candidate SNA-12...

Psoriatic Arthritis - A Pipeline Analysis Report | Technavio

Technavio has announced their latest pipeline analysis report on the psoriatic arthritis market. The report compris

Events [0 Results]

None

Companies [22 Associated Companies listed on BioPortfolio]

Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion d...

Arrien Pharmaceuticals

Arrien Pharmaceuticals is a targeted therapeutics drug discovery and development company. Arrien applies its proprietary fragment-based FIELDS drug discovery technology to targ...

Tiziana Life Sciences plc

Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology. The C...

Santalis Pharmaceuticals, Inc.

Santalis Pharmaceuticals, Inc. is a wholly-owned subsidiary of TFS Corporation, Ltd. (ASX: TFC). Santalis, and its sister company, ViroXis, were acquired by TFS in July 2015 and a...

Ziarco Pharma Ltd.

Ziarco is a clinical-stage biotechnology company developing innovative therapeutics targeting dermatological and inflammatory diseases. ZPL-389, the Company’s lead compound, ...

Akaal Pharma Pty Ltd.

Akaal Pharma Pty Ltd (Akaal Pharma) is a clinical-stage drug discovery and development company focused on the development of novel small molecule drugs for the treatment of inflam...

Provectus Biopharmaceuticals, Inc.

Provectus Biopharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells...

Shape Pharmaceuticals, Inc.

Shape Pharmaceuticals, Inc. is developing SHP-141, a novel, topical, “soft-drug” HDAC inhibitor for the treatment of patients with cutaneous T cell lymphoma (CTCL) and p...

Helmedix Pty Ltd

Helmedix is developing new therapies for autoimmune diseases. The company has identified peptides derived from helminthic worms that have immune-modulating properties. These peptides are being explo...

HealOr

Founded in 2002, HealOr is a privately owned, clinical-stage specialty biopharmaceutical company developing a first-in-class pipeline of topical therapeutics to treat a variety of...

Clinical Trials [658 Associated Clinical Trials listed on BioPortfolio]

A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2

The purpose of this first-in-human study of the formulation ABY-035/AFO2 is to investigate the safety, tolerability and efficacy after multiple doses in sequential escalating dose cohorts ...

Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin

Changes in microbiome have been reported recently in psoriasis lesions compared to healthy surround skin. Preliminary data showed that systemic treatments of psoriasis induce modification ...

Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers

Adalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor necrosis...

A Food Effect Study to Assess Pharmacokinetics of Hemay005 in Healthy Volunteers

The purpose of this study is to evaluate the effect of food on the PK of a single dose of 52.5 mg Hemay005 in healthy subjects.

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.

Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. A total of approximately 24 subjects will be randomized into 3 cohorts(15mg, 30...

Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis

The overall aim of this study is to assess the effects of a new treatment called Secukinumab in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall sup...

A Study to Assess Efficacy, Safety, Tolerability and PK/PD of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis

This is a Phase II, randomized, double-blind, placebo-controlled multicenter study of repeated doses of MOR106 administered as IV infusion. MOR106, is an antibody which is being developed ...

A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.

Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

A phase 4 multicenter, randomized, placebo-controlled Study evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients with moderate-to-severe Scalp Psoriasis

PubMed Articles [352 Associated PubMed Articles listed on BioPortfolio]

Proanthocyanidins: novel treatment for psoriasis that reduces oxidative stress and modulates Th17 and Treg cells.

Psoriasis is a common, chronic, inflammatory skin disease that affects 2%-4% of the global population. Recent studies have shown that increased oxidative stress (OS) and T-cell abnormalities are centr...

Psychiatric morbidity and suicidal behaviour in psoriasis: a primary care cohort study.

Psychological distress among people with psoriasis may lead to elevated risks of suicide and non-fatal self-harm.

Effects of tumor necrosis factor-α, interleukin-23 and interleukin-17A inhibitors on bodyweight and body mass index in patients with psoriasis.

Treatment with tumor necrosis factor-α inhibitors has been reported to cause weight gain in patients with psoriasis; however, limited information is available in terms of the effects of interleukin (...

Importance of phototherapy in the treatment of chronic pruritus.

Phototherapy and photochemotherapy (PUVA) are important treatment modalities in inflammatory skin diseases such as psoriasis and atopic dermatitis as well as in cutaneous T‑cell lymphoma (e.g., myco...

Effect of Prior Biologic Use on Cost-Effectiveness of Brodalumab vs. Ustekinumab for Treatment of Moderate-to-Severe Psoriasis in the United States.

Clinical trials have shown brodalumab to have better efficacy than ustekinumab for the treatment of moderate-to-severe psoriasis. An estimation of the cost-effectiveness of brodalumab vs. ustekinumab ...

Secukinumab decreases the serum KL-6 level in psoriasis patients with elevated serum KL-6 level.

Several papers reported that tumor necrosis factor (TNF)-α inhibitors such as adalimumab (ADA) induced interstitial pneumonia (IP) in patients with rheumatoid arthritis . We here retrospectively inve...

The actin remodeling protein cofilin is crucial for thymic αβ but not γδ T-cell development.

Cofilin is an essential actin remodeling protein promoting depolymerization and severing of actin filaments. To address the relevance of cofilin for the development and function of T cells in vivo, we...

Serum of Patients with Psoriasis Modulates the Production of MMP-9 and TIMP-1 in Cells of Monocytic Lineage.

Psoriasis is triggered by several stimuli that share a systemic production of interferon (IFN)-γ and other inflammatory mediators, which are key to regulate the production of matrix metalloproteinase...

Foxp3 T reg cells control psoriasiform inflammation by restraining an IFN-I-driven CD8 T cell response.

Psoriasis is a complex inflammatory skin disease affecting ∼3% of the population worldwide. Although type I interferons (IFN-I) are thought to be involved in its pathogenesis, the details of this re...

Naturally derived Heme-Oxygenase 1 inducers attenuate inflammatory responses in human dendritic cells and T cells: relevance for psoriasis treatment.

Psoriasis is a chronic autoimmune disease mediated by dysregulated immune responses in dendritic cells (DC) and T cells. The stress-response enzyme heme oxygenase-1 (HO-1) has been described as protec...

Videos

None available.

Medical and Biotech [MESH] Definitions

A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.

A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.

An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.

A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Antibodies
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

Cytokine
Cytokines include chemokines, lymphokines, and monokines. Cells of the immune system communicate with one another by releasing and responding to chemical messengers called cytokines. These proteins are secreted by immune cells and act on other cells to...

Cytokine Tumour Necrosis Factor (TNF)
TNF is a compound that is classified as a cytokine which plays a central role in the cellular mechanisms of apoptosis or cell death. However, there are a number of different kinds of TNF, just under twenty, but the family of molecules have very similar a...

review and buy Ixekizumab (Taltz) market research data and corporate reports here

Channels Quicklinks