Allgenesis Announces Encouraging Preliminary Safety and Efficacy Data from the AG-73305 Phase 2a Trial for the Treatment of Diabetic Macular Edema at American Academy of Ophthalmology

TAIPEI, Nov. 8, 2023 /PRNewswire/ -- 

• AG-73305 was found to be safe and tolerable with no severe adverse effects (SAEs) after a single intravitreal injection of doses of 0.5, 1, 2, and 4 mg in DME patients.
• Data combining all 4 cohorts showed mean improvement in Best Corrected Visual Accuity (BCVA) of +6.4 ETDRS letters with mean Central Subfield Thickness (CST) improvements of -100 microns at 4 weeks post-injection.
• The efficacy lasted up to 24 weeks after a single injection of AG-73305. 
• Kaplan-Meier analysis showed approximately 66% probability that patients did not require rescue by 24 weeks.

Allgenesis Biotherapeutics Inc. presented exciting preliminary data from the first-in-human, Phase 2a clinical trial assessing the safety, tolerability, and efficacy of AG-73305 in Diabetic Macular Edema (DME) patients.  The data was presented as a paper presentation at the 2023 American Academy of Ophthalmology (AAO) conference, which was held from November 2 to 6 in San Francisco, CA.  

Preliminary data from the 22-patient study demonstrated that AG-73305, a bi-functional Fc-fusion protein designed to block VEGF and integrin pathways, was safe and tolerable after a single intravitreal injection.  There were no dose-limiting toxicities and no SAEs related to AG-73305 in patients. Efficacy assessments for the 4 cohorts showed a mean improvement in BCVA of +6.4 ETDRS letters with CST reduction of -100 microns 4 weeks after the injection.  The effects lasted between 12 and 24 weeks after a single injection and Kaplan-Meier analysis showed approximately 66% probability that patients did not require rescue by 24 weeks. "We are very excited to share this preliminary data at AAO and we are equally encouraged that our data and approach was well-received by the ophthalmology community." said Madhu Cherukury, Ph.D., DABT., CEO of Allgenesis. "The data from our Phase2a study supports the hypothesis that blocking multiple pathways in the disease state can provide additional benefits to DME patients in the form of BCVA gains with the potential to push for the extend durability vs. current standard of care."

"We are extremely encouraged by the safety and efficacy outcomes after just one intravitreal injection, with 54.5% of patients seeing 10 or more letter improvements", said Sunil Patel MD, PhD., Chief Medical Officer. "Given its novel mechanism of action, AG-73305 has the potential to be a disease modifying therapy for retinal diseases and the next generation treatment option for DME patients."

"Given the positive data that we are seeing from the open label study, we are forging ahead with the next phases of our development plans and looking forward to unlock the true potential of AG73305 in a Phase 2b study in DME patients." said Dr. Cherukury.

In September 2021, Allgenesis announced it entered into a licensing agreement with AffaMed Therapeutics for the development and commercialization of AG-73305 in Greater China, South Korea, and multiple ASEAN markets.

About AG-73305

AG-73305 is a humanized, bi-specific Fc-fusion protein designed to simultaneously block VEGFs and integrins for the treatment of DME, nAMD, RVO, and other retinal diseases. AG-73305 contains a VEGF-trap and a disintegrin that blocks various key integrin receptors. AG-73305 has the potential to treat both anti-VEGF responders and non-responders. The Phase 2a first-in-human study is expected to be completed in March 2024.

About Allgenesis Biotherapeutics Inc.

Allgenesis is a clinical-stage biopharmaceutical company headquartered in Taiwan. The company is focused on research and development of novel medicines for the treatment of eye diseases. Current projects in the pipeline include AG-73305, a potential blockbuster drug for the treatment of DME, nAMD, and other retinal diseases such as RVO, and AG-80308 for Dry Eye Disease.