drugset / Press release

Zydus to present on ZYIL1 at the International Congress of Parkinson’s Disease and Movement Disorders

2023-08-25 · Zydus Lifesciences Limited · original zyduslife.com ↗

Zydus to present on ZYIL1 at the International Congress of Parkinson’s Disease and Movement Disorders® ZYIL1 decreased α synuclein expression and improved motor function in non-clinical models of Parkinson’s Disease Ahmedabad, India, 25 August 2023 Zydus Lifesciences, a leading discovery -based, global pharmaceutical company announced today that a poster highlighting the company’s oral small molecule NLRP3 inhibitor, ZYIL1, will be presented at the upcoming Internatio nal Congress of Parkinson's Disease and Movement Disorders® to be held from August 27th to 31st 2023 in Copenhagen, Denmark. Abstract Title: Identification of ZYIL1, a novel NLR family pyrin domain containing 3 protein inhibitors: a potential disease modifier in Parkinson’s disorder Abstract Number: 1346 Abstract Category: Parkinson’s Disease: Pharmacology and Therapy Presentation Date: Wednesday, August 30, 2023 Presentation Time: 13:00 - 15:00 Mr. Pankaj R. Patel, Chairman, Zydus Lifesciences said, “Parkinson’s is a devastating disease with patients steadily losing the control on movements leading to unintended or uncontrollable movements, such as shaking, stiffness and difficulty with balance and coordination. Zydus has embarked on a novel disease modifying approach through inhibiting NLRP3 inflammasome activation through ZYIL1, thereby decreasing α -synuclein expression and reducing neuroinflammation, which may potentially prevent neurodegeneration thereby controlling Parkinson’s Disease. This is a step forward in our ongoing endeavour to developing novel therapies and addressing unmet healthcare needs of patients.” ZYIL1 is a novel oral small molecule NLRP3 inhibitor. Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation. ZYIL1 was found distributed in the brain & CSF of various nonclinical species including mice, rats and non -human primates. The efficacy of ZYIL1 has been established in a number of validated pre -clinical models of neuroinflammation and Parkinson’s Disease. ZYIL1, has demonstrated desirable ADME profile, with good safety margin. In Phase I studies, ZYIL1 was found to be safe and well-tolerated in human volunteers [NCT04731324, NCT04972188]. Previously, Zydus had demonstrated efficacy of ZYIL1 in CAPS (Cryopyrin Associated Periodic Syndrome) patients [NCT05186051], and was the first to establish the Phase 2 proof- of-concept with an oral small molecule NLRP3 inhibitor in CAPS patients. The Phase-2 data of ZYIL1 in CAPS has now been published in “Clinical Pharmacology in Drug Development”. Zydus has been granted an ‘Orphan Drug Designation’ by the USFDA for ZYIL1 in treatment of patients with CAPS, a rare auto-inflammatory disease. Reference: 1. ClinicalTrials.gov Identifier: NCT04972188 A Phase I, Prospective, Open Label, Multiple Dose Study of ZYIL1 Administered Via Oral Route to Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Healthy Adult Subjects 2. ClinicalTrials.gov Identifier: NCT04731324 A Phase 1, Prospective Open Label, Single Dose, Single Arm Study of ZYIL1 Administered Via Oral Route to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Adult Human Subjects 3. ClinicalTrials.gov Identifier: NCT05186051 A Phase 2a, Prospective, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects with Cryopyrin Associated Periodic Syndromes (CAPS) 4. Safety, Tolerability, Pharmacokinetics and Pharmacodynami cs of the Oral NLRP3 Inflammasome Inhibitor ZYIL1: First-in-human Phase 1 studies (Single Ascending Dose and Multiple Ascending Dose), Clinical Pharmacology in Drug Development, 2022. DOI: 10.1002/cpdd.1162 5. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 1–8. DOI: 10.1002/cpdd.1318. About Zydus The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs nearly 24,000 people world wide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com

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