RZ402 / Rezolute, Handok, Xoma - LARVOL DELTA

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=94 | Completed | Sponsor: Rezolute | Active, not recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

Results from a Phase 2a Study of a Novel Orally Administered RZ402 a Plasma Kallikrein Inhibitor in Patients With Diabetic Macular Edema (AAO 2024) - No abstract available

Clinical • Late-breaking abstract • P2a data • Diabetic Macular Edema • Ophthalmology

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Rezolute | Trial completion date: May 2024 ➔ May 2025

Trial completion date • Diabetic Macular Edema • Ophthalmology

Rezolute Reports Positive Topline Results from Phase 2 Proof of Concept Study of RZ402 in Patients with Diabetic Macular Edema (DME) (GlobeNewswire) - P2 | N=100 | NCT05712720 | Sponsor: Rezolute | "94 participants were enrolled in the U.S. multi-center, randomized, double-masked, placebo-controlled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week (three month) treatment period....RZ402 met both primary endpoints of change in macular edema (CST) and a good safety profile. CST improved significantly at all RZ402 dose levels compared to placebo (up to approximately 50 microns; p=0.02); Continued downward trajectory in CST over course of study and at end of treatment; No significant difference between RZ402 dose levels, though response was largest at the 200 mg dose; Sub-analysis by DME severity (CST ≥400 microns) indicates an improvement of approximately 75 microns at the 200 mg dose."

P2 data • Diabetic Macular Edema

Recent advances in the discovery and development of drugs targeting the kallikrein-kinin system. (PubMed, J Transl Med) - "The therapeutic impact of targeting the kallikrein-kinin system is no longer limited to the treatment of hereditary angioedema. Ongoing research on other diseases demonstrates the potential of therapeutic interventions targeting the kallikrein-kinin system and will provide further treatment options for patients in the future."

Journal • Review • Cardiovascular • Complement-mediated Rare Disorders • Diabetic Macular Edema • Diabetic Retinopathy • Hereditary Angioedema • Inflammation • Ophthalmology • Rare Diseases • Retinal Disorders

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Rezolute | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2024 ➔ May 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Enrollment closed • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Rezolute

Trial completion date • Diabetic Macular Edema • Ophthalmology

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Rezolute | Trial primary completion date: Sep 2023 ➔ Dec 2023

Trial primary completion date • Diabetic Macular Edema • Ophthalmology

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Rezolute

New P2 trial • Diabetic Macular Edema • Ophthalmology

Randomized Phase 1 Trials of RZ402, a Novel Orally Administered Plasma Kallikrein Inhibitor Targeting Diabetic Macular Edema (ASRS 2022) - No abstract available

Clinical • P1 data • Diabetic Macular Edema • Ophthalmology

"$RZLT FDA Clears Rezolute’s IND Application for RZ402 https://t.co/vboEDBojEK" (@stock_titan)

Rezolute, Inc. announces updates to clinical and business operations in response to COVID-19 pandemic (GlobeNewswire) - "The Company continues to prepare for an investigational new drug application ('IND') for RZ402 in accordance with public health guidelines. Currently, Rezolute believes that IND-enabling activities will be completed by Q3 2020; however, as a result of COVID-19 it is unclear when we will be able to initiate and complete the Phase 1 study."

IND • Diabetic Macular Edema • Macular Edema • Ophthalmology • Retinal Disorders

Nonclinical safety and pharmacology of RZ402, a plasma kallikrein inhibitor, for the treatment of diabetic macular edema as a daily oral therapy (ARVO 2020) - "No histopathological changes were observed in any organs. Additionally, no adverse effects were observed in respiratory and CNS safety pharmacology studies in rats (dosed orally at up to 1000 mg/kg) or in a cardiovascular safety pharmacology study in monkeys (dosed orally at up to 400 mg/kg).Conclusions In summary, RZ402 is a safe and effective preclinical drug candidate for DME, with an ADME and safety profile in rodent and non-rodent species supporting the potential for once-daily oral dosing in the clinic."

Clinical

Newly added product (GlobeNewswire) - Preclinical, DME

Pipeline update