Graves Ophthalmopathy Therapeutics - Pipeline Analysis 2018 | Roivant Sciences, Enceladus Pharmaceuticals, Apitope, Horizon

Graves’ ophthalmopathy is identified as an autoimmune disease in which the overproduction of thyroid hormones affects ocular and orbital tissues. According to the research studies, this disease is associated with elevated TSH receptor expression in the tissues of the orbit, with increase in the level of TSH receptor antibodies.

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Graves’ ophthalmopathy is of two types: type I (lipogenic) and type II (myogenic). Type I form of the disease is characterized by soft tissue edema and orbital fat increase, whereas the type II form is characterized by extraocular muscle enlargement. Double vision, bulging of the eye (proptosis), swollen eyelids, dry eyes, and increased sensitivity toward light are some of the symptoms associated w ith Graves’ ophthalmopathy.

The pipeline of Graves’ ophthalmopathy consists of only a handful of drugs, that are currently in the Phase III, Phase II, and Unknown stages of development. Also, majority of the pipeline products are currently undergoing Phase II clinical studies.

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According to the research findings, majority of the Graves’ ophthalmopathy therapeutics in the pipeline are being developed for intravenous administration. It has been observed that the intravenous route of medication is convenient and ensures that the entire administered dose reaches the systemic circulation immediately. Also, administration of Graves’ ophthalmopathy therapeutics through intravenous route have shown promising results in the clinical studies.

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The companies developing therapeutics for the treatment of Graves’ ophthalmopathy have shown positive clinical results in the various phases of drug development. For instance, in April 2019, Horizon Pharma plc announced results of teprotumumab, from the Phase III confirmatory clinical trial, which showed a significant reduction in complications of this disease. The drop-out rate was observed to be low and balanced across placebo and treatment arms. Also, there were no deaths and only three serious adverse events were reported.

In the wake of various strategic development activities, Roivant Sciences GmbH and HanAll Biopharma Co. Ltd. entered into a strategic collaboration and licensing agreement to develop, manufacture, and commercialize, RVT-1401, for the treatment of IgG-mediated autoimmune diseases. As per the terms of the agreement, Roivant Sciences GmbH gained exclusive license of RVT-1401 in the U.S., Canada, Mexico, U.K., Switzerland, Latin America, North Africa, and Middle East. Therefore, strategic development activities, such as collaborations and acquisitions with other companies can help the current players in the pipeline to expand their drug portfolio for the treatment of Graves’ ophthalmopathy.

Horizon Pharma plc has been granted orphan, fast-track, and breakthrough therapy designation by the USFDA for its product teprotumumab. The grant of these designations plays a major role in the development of teprotumumab, increasing its chances to become the first targeted therapy for Graves’s ophthalmopathy to enter the market. Horizon Pharma plc plans to file biologics license application (BLA) for teprotumumab in mid-2019 and anticipates that its drug candidate will enter the market by 2020.
Horizon Pharma plc, Roivant Sciences GmbH, Enceladus Pharmaceuticals BV, and Apitope International NV are some of the companies involved in the development of Graves’ ophthalmopathy therapeutics.

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This release was published on openPR.