November 15, 2021, Shanghai, China – Luye Pharma Group today announced that it has submitted the Investigational New Drug (IND) application for its innovative microspheres injection LY03009 in the U.S., which will undergo Phase I clinical trials soon. LY03009 is for treating Parkinson's disease (PD) and restless legs syndrome (RLS). It is developed on Luye Pharma's world-leading long-acting and extended release technology platform. In addition to the U.S., the drug is also about to undergo clinical trials in China and is already undergoing Phase I clinical trials in Australia.
PD and RLS are central nervous system (CNS) diseases common for middle-aged and older people, and can seriously affect patients’ quality of life. PD is characterized by clinical manifestations of motor symptoms such as tremor, myotonia, and bradykinesia, as well as non-motor symptoms such as sleep disorder, cognitive impairment, and mental disorder . RLS is a common neurological sensory disorder that is characterized by a strong, almost irresistible urge to move the legs, mostly occurring in the evening or at night. The symptoms can be aggravated by rest and relieved by movement .
LY03009 is a once-a-month, long-acting microspheres injection. During the set dosing intervals, it can achieve stable plasma drug levels and thus provide continuous dopaminergic stimulation, which helps postpone the introduction of levodopa in the treatment process. LY03009 has the potential to improve motor and non-motor symptoms for patients with PD, including postponing the onset of motor complications and improving sleep disorder. It alleviates symptoms, and improves the quality of sleep and the quality of life for RLS patients. In addition, the once-a-month dosing interval means a lower dosing frequency and a simpler treatment regimen, which is expected to improve patient compliance and clinical outcomes.
As population aging around the globe is becoming worse, the number of patients suffering from PD, RLS and other CNS disorders keeps increasing. It is estimated that worldwide around 10 million people are living with PD , and about 7-10% of the U.S. population may have RLS . These diseases present a major challenge to patients and their family members taking care of them.
CNS is one of the key therapeutic areas where Luye Pharma has a strategic presence. The company has built a robust product portfolio to address unmet treatment needs in this field, covering depression, PD, schizophrenia, bipolar disorder, and Alzheimer's disease, among others, with offerings like Risperidone Microspheres for Injection (II) (Rykindo®), Rivastigmine Multi-Day Transdermal Patch, and Quetiapine Fumarate Tablets (Seroquel®) and its extended-release tablets. In addition, a number of Luye Pharma's investigational drugs are already in the late stage of clinical development or the New Drug Application (NDA) stage in the U.S., China and other markets, and are expected to deliver benefits to patients around the world soon.
1.陈生弟, 陈海波. 中国帕金森病治疗指南（第四版）. 中华神经科杂志. 2020,53(12):974-975
4.Restless Legs Syndrome Fact Sheet, National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Restless-Legs-Syndrome-Fact-Sheet