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Luye Pharma’s Innovative Formulation LY03003 Meets Primary Endpoints in Phase III Clinical Trial for Treating Parkinson’s Disease

2022 / 07 / 20 Publisher:Luye Life Sciences Group

July 19, 2022 - Luye Pharma Group announced today that its investigational drug Rotigotine Extended-release Microspheres for Injection (LY03003) has met the expected endpoints in a phase III clinical trial in China for treating Parkinson’s disease.

LY03003 is the world’s first drug that can produce long-term Continuous Dopaminergic Stimulation (CDS) and also one of the key new drugs developed by Luye Pharma on its globally leading microsphere platform. Luye Pharma has developed a range of products on this platform in major therapeutic areas including oncology and the Central Nervous System (CNS), with clinical trials being conducted in China and many other countries.


Numerous patients with Parkinson’s disease are expected to benefit from the new drug

As population aging is becoming worse around the world, the number of patients suffering from Parkinson’s disease is also increasing. According to statistics, approximately 10 million people worldwide are living with the disease . China’s number of Parkinson’s disease patients is expected to increase from 1.99 million in 2005 to nearly 5 million by 2030, which is almost half of all the patients with Parkinson’s disease in the world. Currently, pharmacological and surgical treatments can only improve symptoms, but can’t provide a cure or prevent progression, making long-term management necessary for the disease .

LY03003 is delivered through weekly intramuscular injection. It is designed to improve patients’ symptoms throughout the day and their quality of life. The stable release of the drug can improve the motor and non-motor symptoms in patients with early and advanced Parkinson’s disease and reduce their ‘‘on-off’’ phenomenon and motor complications. The long-term application of the drug is expected to delay the development of motor complications.

The phase III study conducted in China was a multicenter, randomized, double-blinded and placebo-controlled study to evaluate the efficacy and safety of LY03003 in early-stage Parkinson’s disease. 294 Chinese patients with early-stage idiopathic Parkinson’s disease were enrolled in the study and randomized into the LY03003 group and the placebo group in a ratio of 1:1. Results of the study showed that the score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II + III was significantly improved from baseline in the LY03003 group compared with the placebo group, and the difference between the two groups was statistically significant (P < 0.001). Relevant secondary endpoints in both groups were also statistically significant (P < 0.001). Generally, LY03003 was safe and well tolerated, and there were no serious adverse events (SAE) related to the investigational medicinal product (IMP). The results indicate that LY03003 is safe and effective in the treatment of early-stage idiopathic Parkinson's disease and provides a comprehensive improvement in the motor symptoms of Parkinson's disease.

Currently, LY03003 is being developed simultaneously in China, the U.S., Europe, and Japan. The company plans to register and launch LY03003 in those markets and other countries. In addition to the weekly formulation, Luye Pharma is also developing the monthly injections, to provide a better option for the treatment of Parkinson’s disease.


The accelerated commercialization of innovations from the leading microsphere platform

Microspheres are a new type of advanced formulations. They can be designed to have the medications released at different speeds and over different periods for different clinical needs. The medications can be released steadily and continuously for a period from one week to several months, to improve efficacy, safety and patient compliance. However, microspheres are complex formulations that are technologically advanced and difficult to develop and manufacture. This technique is monopolized by several overseas companies. Luye Pharma has been developing innovative microspheres for many years, and has been able to achieve the commercial production of microspheres. While breaking the monopoly by overseas companies, it is able to lower medical expenses for patients and increase the accessibility of drugs for them.

Luye Pharma has built a robust product portfolio on the microsphere platform to address the needs of patients. In addition to LY03003, the Risperidone Microspheres for Injection (II) (Rykindo®) has been approved for launch in China, and its New Drug Application (NDA) is being reviewed in the U.S.; and the Goserelin Acetate Extended-release Microspheres for Injection (LY01005) is having its NDA reviewed in China. The upcoming new drugs will produce a synergy with the ones already available in the market, to demonstrate the company's strength in this field and provide new and high-quality options for patients.

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