ZYIL1 is a 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 neuro-inflammation 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. The phase 2 study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with Parkinson’s Disease, said the firm.

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 co-ordination.

“It is estimated that there are more than 8.5 million people in the world suffering from Parkinson’s disease, with 1 million suffering from the disease in the US. Each year 90,000 new cases of Parkinson’s disease are reported in the US. Analysts estimate that the treatment costs of Parkinson’s disease amounts to almost US $52 billion every year, and by 2037 this disease is estimated to touch US $80 billion every year,” the company stated in the press release.

Pankaj R. Patel, chairman, Zydus Lifesciences, said, “Our team is developing a novel, disease modifying approach through inhibiting the activation of NLRP3 inflammasome with ZYIL1, which could potentially reduce neuroinflammation and neuro-degeneration in patients suffering from Parkinson’s disease.”

Previously, Zydus had demonstrated efficacy of ZYIL1 in CAPS (Cryopyrin Associated Periodic Syndrome) patients, 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 US FDA for ZYIL1 in treatment of patients with CAPS, a rare auto-inflammatory disease, the pharma company added.

Additionally, the company has also initiated phase 2 clinical trial of ZYIL1 in patients with Amyotrophic Lateral Sclerosis (ALS), a neurodegenerative disease.

Meanwhile, the drug major said that it has received a final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Lacosamide Tablets.

Lacosamide is indicated to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company consolidated net profit surged 53.2% to Rs 800.7 crore in Q2 FY24 as compared with Rs 522.5 crore posted in Q2 FY23. Revenue from operations rose 9.1% YoY to Rs 4,368.8 crore during the quarter ended 30 September 2023.