Luye Pharma Group announced today that the phase I clinical trial of the Rotigotine Extended-Release Microspheres for injection (LY03003) for Parkinson’s disease has been completed in Japan. The results show good safety and tolerance results, providing a clear reference and basis for future studies.
LY03003 is a worldwide first – the first product to produce long-term Continuous Dopaminergic Stimulation – and also one of the key innovative drug candidates developed by Luye Pharma through its world-leading microsphere technology platform. The drug is being developed concurrently in the markets of China, the U.S., Europe, Japan and several other countries or regions. It is currently under phase III clinical trial in China and the U.S.
The phase I study conducted in Japan was an open-label, parallel-group, multiple-dose study to evaluate the safety, PK, and preliminary efficacy of LY03003. 35 Japanese patients with Parkinson’s disease took part in the study. LY03003 shows dose proportionality in terms of systemic exposure at the doses tested, and a sound dose-correlation with another marketed patch products was established. Five consecutive intramuscular injections of LY03003 at 14, 28 or 56 mg were safe and well-tolerated. The status of the disease as assessed by UPDRS (Part III) showed numerical improvement and remained stable for all patients treated with LY03003 during the study.
According to the Journal of Neurology, Parkinson’s disease is the most common movement disorder and is the second most common neurodegenerative disease in Japan. Data from the Journal of eNeurologicalSci indicate that there were approximately 127,000 to 256,000 patients with Parkinson’s disease in Japan in 2016.
LY03003 delivers medication by weekly intramuscular injection. It is designed to improve the patients’ symptoms and quality of life throughout the day. The stable release of the drug in the human body can improve the motor and non-motor symptoms in patients with Parkinson’s disease, and reduce the ‘‘on-off’’ phenomenon and motor complications in patients with advanced stage Parkinson’s disease. It is anticipated that long-term application of the drug will delay the development of motor complications. In addition to the weekly formulation, Luye Pharma is developing Rotigotine Extended-Release Microspheres for monthly injections. This is expected to provide a more favourable option for the clinical treatment of Parkinson’s disease.
“With the aging population worldwide, we believe that LY03003 has promising market prospects and will enrich the Group’s future product portfolio,” said a spokesperson from Luye Pharma Group. “We are accelerating the development and registration of in-house developed pipeline products, hoping to help more patients in need.”
Under its innovative microsphere technology platform, Luye Pharma has several other microspheres injection products in various stages of development, for major therapeutic areas such as oncology and the central nervous system. These include Risperidone Microspheres for Injection (Rykindo®, for the treatment of schizophrenia) approved for marketing in China on 14 January 2021, Goserelin Acetate Extended-Release Microspheres for Injection (LY01005) for prostate cancer, breast cancer and other sex hormone dependent diseases, and LY03009 for Parkinson’s disease and restless legs syndrome. With clinically advantageous dosing cycles ranging from one week to three months, and better efficacy and safety, these microsphere formulations will help simplify treatment regimens for physicians, improve patient compliance, and meet clinical needs. Together with the company's existing commercialized products they will constitute a rich product portfolio, and synergize with existing resources and strengths to accelerate the company's global strategy in its core therapeutic areas.
Luye Pharma Group announced today that the phase I clinical trial of the Rotigotine Extended-Release Microspheres for injection (LY03003) for Parkinson’s disease has been completed in Japan. The results show good safety and tolerance results, providing a clear reference and basis for future studies.
LY03003 is a worldwide first – the first product to produce long-term Continuous Dopaminergic Stimulation – and also one of the key innovative drug candidates developed by Luye Pharma through its world-leading microsphere technology platform. The drug is being developed concurrently in the markets of China, the U.S., Europe, Japan and several other countries or regions. It is currently under phase III clinical trial in China and the U.S.
The phase I study conducted in Japan was an open-label, parallel-group, multiple-dose study to evaluate the safety, PK, and preliminary efficacy of LY03003. 35 Japanese patients with Parkinson’s disease took part in the study. LY03003 shows dose proportionality in terms of systemic exposure at the doses tested, and a sound dose-correlation with another marketed patch products was established. Five consecutive intramuscular injections of LY03003 at 14, 28 or 56 mg were safe and well-tolerated. The status of the disease as assessed by UPDRS (Part III) showed numerical improvement and remained stable for all patients treated with LY03003 during the study.
According to the Journal of Neurology, Parkinson’s disease is the most common movement disorder and is the second most common neurodegenerative disease in Japan. Data from the Journal of eNeurologicalSci indicate that there were approximately 127,000 to 256,000 patients with Parkinson’s disease in Japan in 2016.
LY03003 delivers medication by weekly intramuscular injection. It is designed to improve the patients’ symptoms and quality of life throughout the day. The stable release of the drug in the human body can improve the motor and non-motor symptoms in patients with Parkinson’s disease, and reduce the ‘‘on-off’’ phenomenon and motor complications in patients with advanced stage Parkinson’s disease. It is anticipated that long-term application of the drug will delay the development of motor complications. In addition to the weekly formulation, Luye Pharma is developing Rotigotine Extended-Release Microspheres for monthly injections. This is expected to provide a more favourable option for the clinical treatment of Parkinson’s disease.
“With the aging population worldwide, we believe that LY03003 has promising market prospects and will enrich the Group’s future product portfolio,” said a spokesperson from Luye Pharma Group. “We are accelerating the development and registration of in-house developed pipeline products, hoping to help more patients in need.”
Under its innovative microsphere technology platform, Luye Pharma has several other microspheres injection products in various stages of development, for major therapeutic areas such as oncology and the central nervous system. These include Risperidone Microspheres for Injection (Rykindo®, for the treatment of schizophrenia) approved for marketing in China on 14 January 2021, Goserelin Acetate Extended-Release Microspheres for Injection (LY01005) for prostate cancer, breast cancer and other sex hormone dependent diseases, and LY03009 for Parkinson’s disease and restless legs syndrome. With clinically advantageous dosing cycles ranging from one week to three months, and better efficacy and safety, these microsphere formulations will help simplify treatment regimens for physicians, improve patient compliance, and meet clinical needs. Together with the company's existing commercialized products they will constitute a rich product portfolio, and synergize with existing resources and strengths to accelerate the company's global strategy in its core therapeutic areas.
