migaldendranib subcutaneous (D-4517.2 SC) / Ashvattha Therap - LARVOL DELTA

Treatment of Retinal/Choroidal Vascular Diseases by Sustained Delivery of VEGF Receptor Tyrosine Kinase Inhibitors. (PubMed, Am J Ophthalmol) - "Sustained delivery of VEGF receptor TKIs represents a promising therapeutic paradigm for retinal and choroidal vascular diseases, potentially reducing treatment burden while maintaining efficacy. Continued evaluation through larger, controlled clinical trials is essential to validate these early findings and define the role of these agents in clinical practice."

Clinical • Journal • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ashvattha Therapeutics to Present Phase 2 DME and Wet AMD Data at Clinical Trials at the Summit and MaculArt (GlobeNewswire) - "Ashvattha will present Phase 2 data on migaldendranib, a subcutaneous therapy for DME and wet AMD, which could offer a more patient-friendly alternative to current injection-based treatments."

P2 data • Age-related Macular Degeneration • Diabetic Macular Edema

Tejas: Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Ashvattha Therapeutics, Inc. | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Nov 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ashvattha Therapeutics to Present at ARVO, Retina World Congress, and AOS Annual Meeting (GlobeNewswire) - P2 | N=50 | Tejas (NCT05387837) | Sponsor: Ashvattha Therapeutics, Inc.| "These presentations will highlight Phase 2 results for migaldendranib (MGB), Ashvattha’s investigational subcutaneous treatment for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Phase 2 clinical data demonstrated that MGB administration lowered production of subretinal fluid reducing or eliminating the need for intravitreal anti-VEGF treatment in both the study eye and fellow eye in wet AMD and DME subjects with bilateral disease. New data indicates that MGB may be the first safe systemic therapy for the treatment of wet AMD and DME without ocular adverse events. The new data will be presented in three presentations, including a poster session and two oral presentations."

P2 data • Age-related Macular Degeneration • Diabetic Macular Edema

Subcutaneous Migaldendranib Reduces Anti-VEGF Treatment Burden; A Unique Therapeutic Platform to Treat Retinal Vascular Disease (ARVO 2025) - P2 | "Migaldendrinib (MGB; D-4517.2) is a VEGF receptor tyrosine kinase inhibitor covalently linked to a hydroxyl dendrimer that targets inflammation...In addition, patients may be able to treat themselves with at-home dosing of MGB. This could be more convenient than needing continual repeated injections into the eye, administered in a doctor's office, to treat these vision threatening diseases"

Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ashvattha Presents Positive Phase 2 Data for Subcutaneous Migaldendranib at Angiogenesis 2025 Conference (GlobeNewswire) - P2 | N=50 | Tejas (NCT05387837) | Sponsor: Ashvattha Therapeutics, Inc.| "In subjects completing 24 weeks of treatment at this interim analysis, key findings included: i) 69.2% and 76.5% reduction in anti-VEGF treatment burden for wet AMD and DME study eyes, respectively, versus 24 weeks prior to screening; ii) Maintenance of mean central subfield thickness (CST) and best corrected visual acuity (BCVA) in wet AMD study eyes; iii) Modest decreases in CST (-69.1 microns) with modest increases in BCVA (+4.5 ETDRS letters) in DME study eyes; iv) Similar effects observed in fellow eyes, which did not receive an anti-VEGF IVT at Day 1 (Baseline), with 66.7% and 94.7% reduction in treatment burden for wet AMD and DME subjects, respectively, with bilateral disease versus 24 weeks prior to screening; v) Generally safe and well-tolerated with no treatment-related ocular adverse events reported."

P2 data • Age-related Macular Degeneration • Diabetic Macular Edema

Tejas: Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Ashvattha Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Tejas: Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Ashvattha Therapeutics, Inc. | N=30 ➔ 50 | Trial completion date: Jun 2023 ➔ Dec 2024 | Trial primary completion date: May 2023 ➔ Nov 2024

Enrollment change • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Oral Formulation Development of the Anti-Angiogenesis Drug D-4517.2 to Treat Age-related Macular Degeneration (wet AMD) and Diabetic Macular Edema (DME) (ARVO 2023) - "Describe the big picture and the implications of your findings, not the study itself and the associated details. To eliminate intravitreal injections, a safe orally administered anti-angiogenesis therapy, D-4517.2, was developed as a potential lifecycle management opportunity of the SC D-4517.2 currently in a Phase 2 trial in patients with wet AMD or DME."

Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Suppression of subretinal neovascularization in Vldlr knockout mice by systemic administration of a targeted VEGF-receptor inhibitor (ARVO 2023) - "D-4517.2 is a new precision nanomedicine technology that inhibits vascular endothelial growth factor (VEGF) receptor tyrosine kinases selectively in reactive microglia and hypertrophic retinal pigment epithelial (RPE) cells...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • CDKN1A • LDLR

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Ashvattha Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Tejas: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (AMD) or Subjects With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Ashvattha Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (AMD) or Subjects With Diabetic Macular Edema (DME) (Tejas) (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Ashvattha Therapeutics, Inc.

New P2 trial • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Safety and Tolerability of a Single Subcutaneous Dose of Anti-Angiogenesis Drug to Treat Neovascular Age-related Macular Degeneration (wet AMD) and Diabetic Macular Edema (DME) (ARVO 2022) - "The GLP toxicology and safety pharmacology studies conducted in rats and dogs indicated a 100-fold safety margin above the maximum proposed human single SC dose (2.0 mg/kg D-4517.2). Allometric scaling of the D-4517.2 efficacious SC doses in the laser-induced CNV mouse model indicated that a SC dose of D-4517.2 of 0.25 to 2 mg/kg may be effective in treating patients with wet AMD or DME. Although D-4517.2 is renally cleared within 24 hours in animals, CNV lesion formation was suppressed for 2 weeks after a single SC in the CNV mouse model1."

Clinical • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Ashvattha Therapeutics, Inc. | Trial completion date: Mar 2022 ➔ Jun 2022 | Trial primary completion date: Mar 2022 ➔ Jun 2022

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Ashvattha Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration