Graves’ Ophthalmopathy Therapeutics - Pipeline Analysis 2019, Clinical Trials and Results, Patents, Designations, Collaborations, and Other Developments

Overview

Graves’ ophthalmopathy (also called Graves’ orbitopathy; thyroid eye disease (TED); dysthyroid/thyroid-associated orbitopathy (TAO)) is an autoimmune disorder wherein ocular and orbital tissues are affected by the overproduction of thyroid hormones. It is considered to be the most common extrathyroidal manifestation of Graves’ disease (GD) and leads to the expansion of extraocular muscles and fat in the eye orbit.

Some of the signs and symptoms associated with this disease include inflammation or redness in conjunctiva, dry eyes, swollen eyelids, increased sensitivity, bulging or forward displacement of the eyes (proptosis), and double vision. The disease can be diagnosed with an eye examination, and through computed tomography, and magnetic resonance imaging (MRI) scans. However, lack of awareness amongst patients about this disease and unavailability of a routine screening have become unmet needs in this therapeutic area.

As per the current scenario, drug developers are actively collaborating and partnering with other companies to expand their pipeline portfolio for the treatment of this disease. For instance, in December 2017, Roivant Sciences GmbH and HanAll Biopharma Co. Ltd. signed a collaboration and licensing agreement under which Roivant Sciences GmbH gained exclusive license to develop, manufacture, and commercialize RVT-1401 (formerly HL161) in the U.S., Canada, Mexico, European Union (EU), the U.K., Switzerland, the Middle East, and North Africa.

Similarly, Horizon Pharma plc, a key player in the Graves’ ophthalmopathy pipeline acquired River Vision Development Corp. to expand its pipeline portfolio. The company gained acquisition rights for teprotumumab from this transaction, which is currently undergoing Phase III clinical studies. Teprotumumab is observed to be a potential drug candidate for the treatment of this disease and has been granted Orphan, Fast-track, and Breakthrough Therapy designation by the United States Food and Drug Administration (USFDA). Furthermore, Horizon Pharma plc is planning to file biologics license application (BLA) for teprotumumab, and the drug is anticipated to hit the market by year 2020.

Key Pipeline Drivers

Positive clinical trial results and strategic decisions of the players to collaborate with other companies are facilitating the growth of the pipeline. For instance, Horizon Pharma plc announced results of teprotumumab, from the Phase III confirmatory clinical trial (OPTIC). According to these results, teprotumumab showed significant reduction in the complications of the disease. In addition, the designations granted by the regulatory bodies and institutes, including the USFDA, the European Medicines Agency (EMA), and the National Institutes of Health (NIH) help in achieving different development milestones for the pipeline drug candidates.

However, unavailability of targeted therapy is a key factor hindering the growth of the pipeline, as there is no marketed product indicated for this disease yet. Further, lack of an early diagnosis due to unavailability of advanced diagnostic tools and unawareness amongst patients, and need for a defined treatment algorithm are other challenges faced by the healthcare providers, as a lot of questions arise in the minds of researchers and healthcare providers while prescribing preventative medicines to the patients.

Pipeline Analysis

The Graves’ ophthalmopathy pipeline currently comprises of 8 therapeutic candidates in different stages of development.

Competitive Landscape

Horizon Pharma plc, Roivant Sciences GmbH, Enceladus Pharmaceuticals BV, and Apitope International NV are the players involved in the development of Graves’ ophthalmopathy therapeutics.

Report Insights

Some highlights of the report “Graves’ Ophthalmopathy Therapeutics – Pipeline Analysis 2019, Clinical Trials and Results, Patents, Designations, Collaborations, and Other Developments” have been mentioned below:

• Detailed pipeline analysis of therapeutic candidates that are being developed for the treatment of Graves’ ophthalmopathy, and estimates and analyses of emerging therapies and their progress status in different phases of development
• Comprehensive insights into pipeline products, with special focus on strategic developments of key players; information on drug licensing, designations, financing, and grants, technological advancements; and upcoming conferences
• Competitive analysis and extensive information on monotherapies, combination therapies, targets and mechanisms of action, and drug origin with relevance to Graves’ ophthalmopathy
• Detailed regulatory framework for drug approval in the U.S., Europe, and Japan
• Key winning strategies of the companies involved in the development of Graves’ ophthalmopathy therapeutics