StemCell Therapy

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On Tuesday, Novartis announced the first interpretable results from its Phase III KESTREL study of humanized single-chain antibody fragment (scFv) Beovu, demonstrating significant improvement in central subfield thickness in Diabetic Macular Edema (DME).

DME occurs when consistently high blood sugar levels cause damage to small blood vessels in the eye, resulting in an accumulation of leaked fluid, or edema, in the macula, a pigmented area near the center of the eye crucial for the human brain to process light and register a sharp, detailed picture. DME is the leading cause of blindness among young adults in developing nations, 40% of whom have either type 1 or type 2 diabetes.

Beovu (brolucizumab, RTH258), is the most clinically advanced humanized scFv and is currently approved in more than 50 countries, including the U.S. and the EU for the treatment of wet AMD (macular degeneration), a condition that causes blurred vision or a blind spot in the visual field.

According to Suying Dang et al in the journal Hybridoma, single-chain variable fragment of antibody (scFv Ab) provides many advantages over monoclonal antibodies, especially for therapeutic purposes, including enhanced tissue penetration due to their small size and abrogated immunogenicity.

In the KESTREL study, Beovu met the primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at the one-year mark and demonstrated significant improvement at the 6 mg does in the change of central subfield thickness (CST) from baseline between weeks 40 and 52.

The results affirm the positive topline results Novartis announced in September from its pivotal KITE Phase III study of Beovu with DME.

Central subfield thickness [CST] is a key indicator of fluid in the retina, which is an indicator for active disease. For many DME patients, frequent anti-VEGF injections are needed to reduce the fluid in the eye and control the disease. The data from KITE and KESTREL suggest Beovu may have the potential to provide DME patients with better disease management through extended dosing intervals resulting in less overall injections, Dirk Sauer, Global Development Unit Head Opthalmology, told BioSpace.

Beovu also met its secondary endpoint, as more than half of participants in the 6 mg arm were maintained on a three-month dosing interval through year one, after the loading phase. Overall, the study showed that Beovu was well-tolerated.

Novartis is interested in determining whether the same level of efficacy can be achieved with an extended dosing interval. The Phase III KITE and KESTREL trials were designed to show non-inferiority in change from baseline in best-corrected visual acuity. The studies looked at Beovu 6 mg on a flexible dosing regimen, allowing for three and two-month dosing intervals versus aflibercept 2 mg on a two-month dosing interval. More than half of Beovu patients in the 6 mg arm were maintained on a three-month dosing interval through year one, following the loading phase, Sauer said. These data suggest Beovu may have the potential to provide DME patients with better disease management through extended dosing intervals, which could ultimately lead to better treatment adherence.

Sauer also stated that Novartis intends to submit the data from both KITE and KESTREL to health authorities in H1, 2021 and looks forward to working with regulators worldwide to make Beovu available to DME patients in need.

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Novartis' KESTREL Study Reaffirms Positive Results of Beovu in DME - BioSpace

This entry was posted on December 16, 2020 at 1:52 am and is filed under Blindness. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |