PERSPECTIVES

Progressing development of therapies for retinal vascular disorders and diabetic eye disease

2019 has been another transformational year for Oxurion. In this first year after the company's rebranding, we conducted three clinical trials. The results of two were encouraging and promising, those of the third rather mixed. Oxurion then made the strategic decision to focus its research on developing non-VEGF compounds to target an unmet medical need for people with diabetic retinal eye disease.

“2019 has been an important year for our clinical developments. We obtained excellent results from two phase 1 clinical trials evaluating two distinct and wholly-owned non-VEGF compounds: THR-149 and THR-687. These have given us a solid basis, a confirmation of our new focus, and a growth platform for the company’s future development”, says Patrik De Haes, M.D., CEO of Oxurion.

“The results from the clinical trials for our molecules THR-149 and THR-687 are indeed very promising. Both compounds not only proved to be very safe and well-tolerated, but they also showed a substantial, clinically relevant early benefit and durability of effect.” This truly ticks all the boxes in developing next-generation therapies for retinal vascular disorders.

Click here for the clinical data of the phase 1 trial of THR-149

Click here for the clinical data of the phase 1 trial of THR-687

Different course, …

Thomas Clay, Chairman of the Board, confirms this. “Oxurion had two very successful phase 1 trials. The data from our study evaluating anti-PlGF (THR-317) for DME were clinically sound but did not show the outcome we were hoping for. The choice to leave that pathway was obvious so we took that decision.”

“We also decided to stop actively promoting Jetrea® ourselves and seek a distribution licensee partner”, Patrik De Haes adds. “With Inceptua Group we’ve found such a partner. In March 2020, Oxurion and Inceptua Group signed a global license agreement for further commercialization of Jetrea®. With that, we fulfilled our commitment to not only secure access to Jetrea® for those patients we believe can truly benefit from this first-in-class medicine, but to do it in a cost-neutral manner for the Company.”

Finally, in 2019 Oxurion also decided to explore and research innovative new therapies for age-related macular degeneration (AMD). AMD is a leading cause of blindness in the world and comes in two varieties. There are treatments for Wet AMD, but for dry AMD there are none. “The focus of the Oxurion preclinical research teams is currently almost exclusively on in-vivo and in-vitro validation of new pathways and compounds for the treatment of dry AMD. We hope to be able to present at least one preclinical proof of concept in 2020″, Patrik continues.

Our molecules are unique, and potentially first in class.

– Patrik De Haes, M.D., CEO of Oxurion

… the same commitment

While Oxurion’s strategic course may have been fine-tuned in 2019, the commitment and focus have remained unchanged: developing therapies for people with diabetic eye disease or age-related macular degeneration.

“Our therapeutic approach also means focusing resources, time, and energy on compounds we believe have the potential to make a life-changing improvement in a person’s vision. For many DME patients, there is still a large unmet need. More than 40% of them have a suboptimal or zero response to treatment with an anti-VEGF, currently the standard of care for the bulk of DME patients. For them we need to find a solution, and we have two validated options in clinical development”, Patrik explains.

We bring experts and investors together, so the retina experts can explain directly the need for compounds we are developing.

– Thomas Clay, Chairman of the board

Value creation

“This strategy is also interesting for our shareholders and potential investors”, Thomas Clay points out. “Our choice to develop non-VEGF compounds is a strategic one. When 40% of DME patients respond poorly to anti-VEGF therapy, common sense says we should look at non-VEGF therapies for them. With THR-149 and THR-687, Oxurion has two unique and wholly-owned compounds in clinical development that are very distinct from any of the anti-VEGF therapies now available or under development.

Not only they represent a great opportunity for many DME patients out there, but they also offer our shareholders and investors the best chance for future value creation. It is obvious that should we succeed in crafting a novel pathway towards a therapy for dry AMD, we expect this to also see this translated into additional value for our shareholders.”

“Oxurion does not hesitate to bring investors and experts together. We want our shareholders and investors to hear from key opinion leaders familiar with our programs why these are innovative and vital for patients”, Thomas continues. “Meanwhile, we feel very encouraged to see key retina opinion leaders in Europe and the US also confirm the potential of THR-149 and THR-687 for treatment of DME.”

> Arshad Khanani, M.D., about THR-687

> Pravin Dugel, M.D., about THR-149

Recruiting for two phase 2 trials

Oxurion is preparing the start of two fully powered phase 2 clinical trials, next to the validation of new pathways towards a therapy for dry AMD. Final approvals for the phase 2 clinical trial evaluating THR-149 in DME are well under way, and Oxurion is making great headway with the prep work for its phase 2 with THR-687 as well.

THR-149 is a plasma kallikrein inhibitor to treat people with DME. This novel therapy yielded encouraging results in the phase 1 clinical trial, producing fast and durable improvement of vision.

The results from the phase 1 evaluation of THR-687, a pan-RGD integrin antagonist, are promising. An almost immediate, significant and durable mean BCVA improvement of vision was reported.

The two compounds target different patient groups. THR-149 will be evaluated in patients who do not or do not optimally react to anti-VEGF treatment (nonresponders/poor responders), while anti-VEGF treatment naïve patients will be selected in the THR-687 phase 2 study. Both studies will test whether multiple doses the compounds can increase and prolong the visual improvement observed in the phase 1 studies.

Oxurion believes that if these fully powered phase 2 trials replicate and maintain the observed benefit from the phase 1 studies, both compounds would become very compelling drug candidates with clear value to the market.

“Of course, the data will speak for themselves, but we feel confident. After all, the Oxurion team has the important experience of successfully developing a medicine from the research bench all the way to the market. We know the way”, says Patrik.

Part of a global retina family

Whilst advancing its retina and vision research, Oxurion seeks to preserve close ties with those in the retina community and the patients they serve. Over the years it has developed close collaborative ventures with US and global organizations such as Prevent Blindness and Retina Global.

Oxurion proudly supports Retina Global’s efforts to educate people on eye disease and proper eye care and to send retina specialists to remote and less privileged corners of the world to provide specialized eye care to those in need.

In the past, we have joined forces with Prevent Blindness in order to boost their ‘Diabetic Eye Disease Awareness Month’-campaigns. Going forward, we are looking into how we can assist and support Prevent Blindness while staging their brand-new nationwide patient engagement and advocacy training program. At Oxurion, we also believe that patients are among the best placed to help create awareness about vision-threatening conditions, disease processes, and the impact of these diseases on daily life.

Confidently looking to the future

“Oxurion has completed its transformation to a full-fledged drug development company with a clear focus.

It now has two exciting phase 2 clinical trials under way evaluating two distinct and very innovative non-VEGF compounds for treatment of DME. We’ve also taken our first steps into the dry AMD arena with its large untapped potential and aim to make a substantial impact there”, Patrik De Haes states.

“We view the future with confidence and ambition”, Thomas Clay concludes.

 

May 5th, 2020