• Disclosure
  • Privacy Policy
  • DMCA Policy
  • CCPA
  • Medical Disclaimer
Friday, February 3, 2023
Massachusetts Digital News
  • Home
  • US
  • Business
  • World
  • Boston
  • Worcester
  • Springfield
  • Cambridge
  • Lowell
  • Brockton
  • Press Releases
  • Videos
No Result
View All Result
  • Home
  • US
  • Business
  • World
  • Boston
  • Worcester
  • Springfield
  • Cambridge
  • Lowell
  • Brockton
  • Press Releases
  • Videos
No Result
View All Result
No Result
View All Result
Home Boston

Oxurion Announces New Data On THR-149 Phase 2 Clinical Trial (“KALAHARI”) In DME At The Angiogenesis, Exudation, And Degeneration 2022 Conference

by Duong
February 14, 2022
in Boston
oxurion-announces-new-data-on-thr-149-phase-2-clinical-trial-(“kalahari”)-in-dme-at-the-angiogenesis,-exudation,-and-degeneration-2022-conference
Share on FacebookShare on Twitter

Oxurion NV

Oxurion NV

  • Post-hoc analysis reveals >9 letter gain in mean BCVA that was maintained for the remaining four months of the trial after the last THR-149 injection with no rescue treatment required

  • These gains were seen in patients that are part of the 40-50% of DME patients that suboptimally respond to standard of care ant-VEGF therapy

Leuven, BELGIUM, Boston, MA, US – 14 February 2022 – 8.00 AM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with a clinical stage portfolio in vascular retinal disorders, presented new data from Part A of its two-part Phase 2 Clinical Trial (“KALAHARI”) assessing THR-149 for treatment of diabetic macular edema (DME) at the Angiogenesis, Exudations, and Degeneration 2022 Meeting on February 11-12th.

THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. High-level Month 3 data from Part A of the KALAHARI trial was first presented in October 2021 and demonstrated that in the 8 patients who received the highest dose of THR-149, a mean BCVA gain of 6.1 letters at Month 3, the primary endpoint, was observed.

The new data reviewed today is a post-hoc analysis of an OCT (Optical Coherence Tomography) biomarker assessment, which was performed by the masked central reading center. The masked reading center identified two subjects with abnormalities at baseline, which could impact responsiveness to treatment. Excluding these two subjects resulted in an improvement in mean BCVA of 9.3 letters at Month 3 that was sustained until Month 6, the end of the trial. The six-month data also demonstrated THR-149’s attractive safety profile and its ability to stabilize the Central Subfield Thickness (CST).

“The data presented today continues to highlight THR-149’s compelling safety and efficacy profile in patients with diabetic macular edema,” commented Arshad M. Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, US. “For patients who are suboptimal responders to standard of care anti-VEGF therapy, the post-hoc analysis of the high-dose cohort in the KALAHARI trial showed encouraging gains in BCVA with over 80% of patients gaining at least 5 letters and 50% of patients gaining at least 10 letters four months after the last THR-149 injection. In addition, CST was stable up to Month 6. These results demonstrate the potential of THR-149 to make a meaningful difference to this patient population, which if left untreated would be expected to experience a further deterioration in their vision.”

Based on Month 3 Part A data, the high dose of THR-149 was selected for Part B of the KALAHARI study to compare vs. aflibercept for the treatment of DME. The learnings from the Part A data presented today have already been incorporated into Part B through an amended study design, which has been approved by the US IRB. The approved protocol amendment optimizes the inclusion and exclusion criteria for Part B and eliminates subjects with potential baseline abnormalities, to further increase the potential for response to treatment. Part B of the trial is currently enrolling with topline data expected mid-2023.

Tom Graney, CFA, Chief Executive Officer of Oxurion, said, “The data Dr. Khanani presented improves our understanding of which patients are most likely to respond to treatment and underscores the potential of THR-149 to address the significant unmet need in patients that experience a suboptimal response to anti-VEGFs and currently lack adequate treatment options. We believe these changes will maximize our ability to achieve a successful trial outcome to the benefit of patients while preserving the positive attributes of the initial trial design and maintaining our timelines.”

Part B of the KALAHARI trial is ongoing, assessing three monthly injections of THR-149, compared to three monthly injections of aflibercept, up to Month 3. As from Month 3, the safety and efficacy of a switched fourth injection (THR-149 to aflibercept or aflibercept to THR-149) will be evaluated in about half of the subjects whereas in the other half of the subjects the durability of three monthly injections (THR-149 or aflibercept) will be assessed through a single sham injection. The trial is planned to randomize approximately 108 subjects in Part B and the primary endpoint remains the mean change in BCVA letter score from baseline, at Month 3.

All dose levels of THR-149 demonstrated a favorable safety profile during Part A of the KALAHARI trial, which was maintained through the end of the trial. All adverse events in the study eye were mild to moderate in intensity and no severe ocular adverse events were reported and no intra-ocular inflammation observed.

About Oxurion


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 retinal vascular disorders including diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet age-related macular degeneration (wAMD) and retinal vein occlusion (RVO).

Oxurion is aiming to build a leading global franchise in the treatment of retinal vascular disorders based on the successful development of its two novel therapeutics. THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. THR-687 is a highly selective pan-RGD integrin antagonist that is being developed as a potential first line therapy for DME patients as well as wAMD and ME-RVO. Oxurion is headquartered in Leuven, Belgium, with corporate operations in Boston, MA. More information is available at www.oxurion.com.

Important information about forward-looking statements

Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

For further information please contact:

Read More…

Related Posts

obituary:-patricia-ann-(bordewieck)-simmonds

Obituary: Patricia Ann (Bordewieck) Simmonds

by Duong
April 14, 2022
0

Obituaries increase font size ROUND POND - Patricia Ann (Bordewieck) Simmonds, 64, of Round Pond passed away peacefully on April 10, 2022 after a long ... Patricia Ann (Bordewieck) Simmonds ROUND POND – Patricia Ann (Bordewieck) Simmonds, 64, of Round Pond passed away peacefully on April 10, 2022 after a...

baseball-fans-pack-polar-park-for-woosox'-home-opener

Baseball Fans Pack Polar Park For WooSox' Home Opener

by Duong
April 13, 2022
0

Worcester Red Sox fans started showing up to Polar Park before doors opened at noon for the team's home opener. "I took the day off. She got dismissed early from school today," said Matthew Lavoie. "We like to come in early, and we like the whole feel of the ballpark...

neonatal-diagnostics-company-infandx-ag-launches-us-operations

Neonatal Diagnostics Company InfanDx AG Launches US Operations

by Duong
April 12, 2022
0

April 12, 2022 04:00 ET | Source: AKAMPION Incorporated US subsidiary & hired US VP Operations Preparing pre-submission meeting with US-FDA Received Notice of Allowance for key patent by USPTO Cologne, Germany, and Boston, MA, USA, April 12, 2022 – InfanDx AG, a privately-held diagnostics company focusing on the development and...

B

by Duong
April 11, 2022
0

Boston Beer Company (The) with ticker code (SAM) now have 14 analysts covering the stock with the consensus suggesting a rating of ‘Buy’. The range between the high target price and low target price is between 670 and 373 with a mean TP of 508.14. With the stocks previous close...

Massachusetts Digital News

© 2021 Massachusetts Digital News

Navigate Site

  • Disclosure
  • Privacy Policy
  • DMCA Policy
  • CCPA
  • Medical Disclaimer

Follow Us

No Result
View All Result
  • Home
  • DMCA Policy
  • Medical Disclaimer
  • Privacy Policy
  • Disclosure
  • CCPA
  • Terms of Use

© 2021 Massachusetts Digital News

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT