Innovent Announces Primary Endpoint Met in the Second Phase 2 Clinical Trial of IBI302 (anti-VEGF/complement) in Treating Neovascular Age-related Macular Degeneration (nAMD)
ROCKVILLIE, Md. and SUZHOU,
According to the results of the two Phase 2 clinical studies conducted in more than 360 subjects of nAMD, compared with Aflibercept, IBI302 can be administrated in long-interval (every 12 weeks), while providing a stable and robust visual benefit and anatomic improvements, as well as potential inhibition effect in macular atrophy. Based on those results, Innovent advanced IBI302 8mg into a Phase 3 clinical study STAR in
This was a randomized, double-masked, active-controlled Phase 2 clinical study (NCT05403749), evaluating the longer interval of intravitreal injection of high-dose IBI302 in subjects with nAMD. A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or Aflibercept 2.0 mg group. After the loading therapy, subjects in IBI302 6.4 mg group and 8.0 mg group were dosed with adjusted intervals of every 8 weeks (Q8W) or every 12 weeks (Q12W), depending on response to loading therapy. Subjects in Aflibercept 2.0 mg group were dosed Q8W after the loading therapy. The primary endpoint was the change in best corrected visual acuity (BCVA) in the study eye from baseline to week 40. The study lasted for 52 weeks.
The results showed that the primary endpoint was successfully met: at week 40, the IBI302 6.4 mg and 8.0 mg groups showed non-inferior BCVA gains to the Aflibercept 2.0 mg group. The mean BCVA improvement from baseline was 10.5 ETDRS letters for the IBI302 6.4 mg group, 11.0 ETDRS letters for the IBI302 8.0 mg group, and 9.8 ETDRS letters for the Aflibercept 2.0 mg group at week 40.
The mean change from baseline in central subfield thickness (CST) was -163.19 μm for the IBI302 6.4 mg group, -184.46 μm for the IBI302 8.0 mg group, and -108.23 μm for the Aflibercept 2.0 mg group at week 40.
In addition, approximately 81%, 88% of subjects in 6.4 mg IBI302 groups and 8.0mg IBI302 groups respectively were able to extend dosing interval to Q12W, similar to that in the proportion of subjects dosed Q12W or longer with Aflibercept 8.0 mg (83% in PULSAR trial)1 or Faricimab (TENAYA & LUCERNE trial, with 79.7% and 77.8% respectively)2 by indirect comparison. Based on the excellent long-interval dosing performance in the Phase 2 studies, the Phase 3 study STAR added Q16W dosing interval regimen for IBI302.
The overall safety profile of IBI302 was favorable, comparable to Aflibercept 2.0 mg, and consistent with previous studies. No new safety signals were identified. Detailed study data will be further analyzed and published in the near future.
Dr.
About neovascular age-related macular degeneration (nAMD)
Age-related macular degeneration (AMD) is a progressive ocular disease involving the macular retina, leading to central visual impairment, the incidence of which increases with age. Neovascular age-related macular degeneration (nAMD) is one of the major forms of AMD, accounting for 15% to 20% of all AMD patients and is the leading cause of central vision loss in AMD patients over 65 years3. The incidence of AMD is increasing year by year in
The pathogenesis of nAMD has not been fully elucidated. It is generally accepted that angiogenesis induced by increased expression of VEGF is the main cause of nAMD, and inflammatory reaction mediated by abnormal activation of complement is also considered to be an important cause of AMD. Ocular anti-VEGF agents have led to significant visual benefits and changed the course of nAMD, but the frequent dosing (every 4 or 8 weeks) currently places a heavy burden on patients, families and society. In addition, the visual benefits of anti-VEGF drug therapy are gradually diminished year by year. In approximately two thirds of nAMD patients with a follow-up for over 7 years, the visual gains from anti-VEGF treatment significantly diminish4. Macular atrophy or retinal fibrosis are important causes of vision loss after long-term anti-VEGF therapy. Currently, drug development for nAMD is mainly focusing on extending the dosing intervals, and there are few drugs under investigation for macular atrophy or retinal fibrosis. Two drugs targeting complement have been approved by the
About Efdamrofusp Alfa (IBI302)
IBI302 is a recombinant fully human bispecific fusion protein of
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi,
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).
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References: |
[1] https://investor.regeneron.com/static-files/e3307e7d-d495-438c-b8bb-c62cdacdb375 |
[2] Heier, Jeffrey S et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 399,10326 (2022): 729-740. |
[3] Sassa Y, Hata Y. Antiangiogenic drugs in the management of ocular diseases: Focus on antivascular endothelial growth factor. Clinical Ophthalmology ( |
[4] Rofagha S, Bhisitkul RB, Boyer DS, Sadda SR, Zhang K, |
[5] FDA. SYFOVRE (pegcetacoplan injection). 2023. |
[6] FDA. IZERVAY (avacincaptad pegol intravitreal solution.2023. |
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