Oxurion NV Business Update - H1 2020
Oxurion NV Business Update - H1 2020
Progressing Clinical Development of Next Generation Diabetic Macular Edema (DME) Therapies – Beyond anti-VEGF
Positive data from Phase 1 study evaluating THR-687, a pan-RGD integrin antagonist, for the treatment of DME
First Patient dosed in Phase 2 (‘KALAHARI’) study evaluating THR-149, a potent plasma kallikrein inhibitor, for the treatment of DME
Total Cash & Investments at €37.9 million as of June 30, 2020
Conference call scheduled on September 17 at 6.30 pm CET (details at the end of the release)
Leuven, Belgium, September 17, 2020 – 17.45 PM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a focus on diabetic macular edema (DME), today issues its business and financial update for the sixth-month period ending June 30, 2020.
Oxurion is focused on developing an industry leading DME franchise based on novel therapies designed to potentially provide improved visual outcomes for all DME patients.
The Company is progressing its pipeline of innovative clinical drug candidates for treating DME. DME is a significant global healthcare problem and the major cause of vision loss in diabetic patients worldwide.
Oxurion’s clinical development pipeline consists of two novel products with different and complimentary, non-VEGF, modes of action:
“We have made significant progress in developing our DME franchise in the first half of 2020. Following the positive Phase 1 results for THR-149 in 2019, in January we announced positive and highly promising Phase 1 results with THR-687 showing that this novel pan-RGD integrin antagonist has the potential to deliver improved visual outcomes to a broad population of DME patients when compared to anti-VEGFs, the current standard of care.
We have recently started our Phase 2 study of THR-149 in patients with DME. This two-part study will first select the optimal dose of THR-149 and will then compare it with aflibercept in terms of improvements in best corrected visual acuity. This Phase 2 data is designed to support our plans to position THR-149 as the treatment of choice for the large number of DME patients who have a sub-optimal response to anti-VEGF therapy.
By successfully developing THR-149 and THR-687, two novel and complimentary drug candidates that could offer improved therapeutic options beyond anti-VGEFs, we believe we are positioned to build an industry leading DME franchise. We are confident that creating this franchise will deliver significant benefits to nearly all DME patients globally and will, in parallel, generate attractive returns for our shareholders.”
Diabetic Macular Edema – Oxurion’s key focus
Diabetic macular edema (DME) is a complication of diabetes caused by fluid accumulation in the macula (central part of the retina), due to leaking blood vessels, leading to swelling of the macular area due to the increased permeability of the vessels.
DME is a result of another complication of diabetes, called diabetic retinopathy (DR), in which blood vessels in the eye are damaged, allowing fluid to escape. DR is the presence and characteristic evolution of typical retinal microvascular lesions in an individual with diabetes. DR is a chronic, progressive, sight-threatening, and life-altering disease, and is the leading cause of vision loss in working-age adults (20-65 years).
DME, which is a consequence of DR, can occur at any stage in the development of DR. More than one in three people living with diabetes will develop some form of DR in their lifetime, and a third of those will have some vision-threatening form of the disease such as DME.
DR and DME are a growing public health concern due to the rapid growth in the number of people with diabetes globally.
An estimated 37.8 million people have been diagnosed with diabetes in the United States (US), European top five countries (EU5) (France, Germany, Italy, Spain, and the United Kingdom), and Japan. If the undiagnosed population is included, the estimated number of people with diabetes in these countries increases to 61.3 million people.
The prevalence of DME was estimated to be 2.8 million people in the US, EU5 and Japan in 2019. The market value for DME treatments in these markets was estimated to be between approximately $3.4 to $3.8 billion in 2019.
The market for DME therapies is dominated by anti-VEGFs, which are the current standard of care. However, anti-VEGFs have been shown to deliver sub-optimal results in a significant portion of the patient population. Around 40% of DME patients have an unsatisfactory early visual response with anti-VEGF therapy, and in many cases anti-VEGFs fail to achieve a clinically meaningful visual improvement.
Oxurion is focused on solving these unmet medical needs in DME.
Oxurion’s Emerging DME Franchise
In general, treatment of DME is centered around anti-VEGF therapies. However, despite the significant success of anti-VEGFs, there will always be a need from both physicians and patients for improved therapies that have:
Those requirements are driving the development of THR-149 and THR-687 to meet specific unmet needs in the market so that both novel compounds could become the new standard of care for patients with DME.
Oxurion’s emerging DME franchise will be based on the successful development of both THR-149 and THR-687, two novel therapeutics with different modes of action designed for specific complementary target patient groups. Oxurion is confident that with both THR-149 and THR-687 it will be able to provide new tailored therapeutic solutions that deliver improved clinical outcomes to most DME patients.
Oxurion’s DME Pipeline
THR-149 – a plasma kallikrein inhibitor for treatment of DME
First patient treated in Phase 2 study evaluating THR-149 for treatment of DME.
THR-149 is a novel plasma kallikrein inhibitor being developed as a potential new standard of care for the 40% of DME patients who respond sub-optimally to anti-VEGF therapy.
THR-149 acts through inhibition of the Plasma Kallikrein-Kinin (PKaI-Kinin) system, a validated target for DME.
The Phase 1 study for THR-149 showed that it:
Importantly, this activity was maintained with an average improvement in BCVA of 6.5 letters at Day 90 following a single injection of THR-149.
Data from this positive Phase 1 study with THR-149 was presented at several major retina conferences in Europe and the US in 2019, including the European Society of Retina Specialists (EURETINA) in Paris and the Retina Society Annual Meeting in London.
THR-149 is currently in a 2-part Phase 2 development program (‘KALAHARI’ study). The first part (Part A) will evaluate 3 dose levels of THR-149 in patients with DME to select the optimal dose which will then be compared against current anti-VEGF standard of care in the form of aflibercept (Eylea) in the second part of the study (Part B). Initial data (from Part A) is expected in mid-2021.
This novel drug candidate was generated using Bicycle Therapeutics’ Bicycles® technology platform.
THR-687 - a small molecule pan-RGD integrin antagonist for the treatment of DME
Positive Phase 1 Results with THR-687 for the treatment of DME – Phase 2 program expected to start in mid-2021
Oxurion is developing THR-687, a best-in-class pan-RGD integrin antagonist, to preserve vision in a broad range of patients with DME.
Topline data from the Phase 1 trial showed that THR-687:
Data from this positive Phase 1 study with THR-687 were presented by a leading retina expert at the Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2020 Meeting in February 2020 in Miami (US).
Oxurion is preparing a Phase 2 study with THR-687 that is expected to start in mid-2021.
In August, Oxurion appointed Grace Chang, M.D., Ph.D. as its Chief Medical Officer (effective August 1, 2020). She will be responsible for leading the Company’s clinical programs for both THR-687 and THR-149 as Oxurion looks to build a world-leading DME franchise that could provide much improved therapeutic solutions for all DME patients.
Dr Chang is a board-certified ophthalmologist and practicing vitreoretinal surgeon with deep expertise in ophthalmic drug research and development.
Dr Chang is currently an adjunct Clinical Associate Professor in the Department of Ophthalmology, Vitreoretinal Service at the University of Southern California in Los Angeles.
In March, Oxurion also appointed Kathleen Paisley as Chief Legal Officer and Michaël Dillen as Chief Corporate Development and Corporate Secretary.
Kathleen is an accomplished lawyer with more than 25 years’ experience in major law firms practicing in Brussels, London and The Hague. She joins Oxurion from AMBOS NBGO where she was a Partner for nearly ten years. Kathleen has extensive experience with International business transactions, especially in the biotech and tech sector, regulatory compliance and EU competition law.
Kathleen has a degree from the Yale Law School as well as an MBA in Finance from Florida Atlantic University and has passed the Certified Public Accountancy exam.
Michaël was the Company Secretary and VP Corporate Development at Mithra Pharmaceuticals SA prior to joining Oxurion. He has 14 years of legal experience, including corporate development, corporate counsel, legal, regulatory, and company secretary activities, for pharmaceutical companies as well as at leading law firms. Previously, he was Chief Legal Officer at Terumo Corp.
Michaël received Law degrees from the University of Antwerp and Queen Mary University of London, and a Business degree from Solvay Brussels School.
JETREA® Marketing Authorization Being Transitioned to Inceptua Group
In March, Oxurion announced the signing of a JETREA® global commercial license agreement with Inceptua Group.
The Inceptua Group is a global pharmaceutical company and service partner spanning the product lifecycle – from clinical trials, through early access programs to licensing and commercialization of products. The Group has offices in Europe, the US and Asia.
On September 15, the Company received the final approval by the European Commission for the official transfer of the Marketing Authorization for JETREA® to Inceptua Group. This means that JETREA® is now being commercialized solely by Inceptua on a world-wide basis. This will allow Oxurion to fully focus on further developing its DME franchise.
Pre-clinical and clinical activities are progressing as planned
During the first six months of 2020, Oxurion reported a gross profit of €0.9 million, compared to a gross profit of €0.6 million for the same period in 2019.
Oxurion’s R&D expenses were €10 million during the first half year of 2020. In the same period of 2019, the R&D expenses were €12 million.
The incremental investments related to the start of the Phase 2 clinical study evaluating THR-149 and the work needed to prepare for the Phase 2 clinical study with THR-687 were largely offset by a €3.6 million decline in costs due to the halting of all THR-317 clinical developments, and an overall reduction of activities related to JETREA®.
Selling and marketing expenses amounted to €1.8 million compared to €3.4 million in the corresponding period of 2019. The decrease is directly related to the discontinuation of commercial support for JETREA®.
General and administrative expenses were €2.7 million. This compares to €3.3 million in the first half of 2019.
For the first half of 2020, Oxurion reported a net loss of €13.3 million (or -€0.35 per share), compared to a net loss of €33.3 million for the same period in 2019. The 2019 figure included the write-off of the €16.9 million remaining JETREA® intangible assets as well as an operating/current loss of €16.4 million.
As of June 30, 2020, Oxurion had €37.9 million in cash, cash equivalents and investments. This compared to €52.9 million as of the end of December 2019.
Conference call in English is scheduled on September 17, 2020, at 6:30 p.m. CET / 5.30 p.m BST
Webcast link to conference call:
Participant telephone numbers:
Brussels: +32 (0) 2 789 8603
A replay of the call will be available on Oxurion’s website (www.oxurion.com) following the live event.
For further information please contact:
Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide.
Oxurion is building a leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:
Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.
More information is available at www.oxurion.com.
Important information about forward-looking statements
Unaudited consolidated statement of profit and loss
Unaudited consolidated statement of financial position
Unaudited consolidated statement of cash flows
Unaudited consolidated statement of changes in equity
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