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Shanghai - Prodegre (Shanghai) Pharmaceutical Co., Ltd. has initiated an investigator-initiated trial (IIT) at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, for PDR-001, a novel peptide-based targeted protein degrader for early-to moderate Parkinson’s disease. The clinical trial initiation meeting brought together key clinical experts from Ruijin Hospital – including Prof. Liu Jun, Chair of Neurology, and Prof. Li Dianyou, Chair of Neurosurgery – and senior leadership from Prodegre, represented by Academician Wang Yutian, the company’s Chairman and Director of the Fudan-Shangsi Center for Neuroscience, and company CEO Tan Shen.
The Study, titled “A Study of the Safety, Tolerability, and Efficacy of Stereotactic Bilateral Basal Ganglia Administration of PDR-001 Injection for α-Synuclein Clearance,” has already enrolled its first patient. During the meeting, the protocol was reviewed in detail, covering mechanism of action, eligibility criteria, trial procedures, surgical approach, and participant protection measures, establishing a clear path for trial execution.
SDM, serving as the full-service CRO for the PDR-001, provides comprehensive support across clinical operations, medical affairs, data management, and SMO. SDM will continue working alongside all stakeholders to advance this China-originated innovative therapy toward global regulatory approval.
Academician Wang Yutian, Chairman of Prodegre and CNS Chief Scientist, noted, “With an estimated 25 million Parkinson’s patients worldwide and still no disease-modifying treatment yet approved, the unmet need remains profound. PDR-001 is a novel peptide-base degrader that directly targets and clears αsynuclein – a key pathogenic driver in Parkinson’s – supported by compelling non-human primate efficacy and safety data. Furthermore, this pipeline pioneers the integration of a protein degrader with localized AAV delivery. This approach enables sustained, high-efficiency expression of the therapeutic peptide across multiple critical brain regions, fundamentally modifying the pathological environment. It holds the potential to significantly delay or even halt disease progression, opening a new therapeutic avenue for causal treatment of Parkinson’s disease.”
Patient screening and enrollment are now active at Ruijin Hospital. Prodegre will collaborate closely with Prof. Liu Jun’s neurology team to ensure efficient, protocol-compliant participant recruitment and high-quality trial conduct.
Tan Shen, CEO of Prodegre, added, “We are honored to integrate our differentiate protein-degradation technology and deep scientific foundation in neurodegenerative diseases with the exceptional clinical resources of Ruijin Hospital, initiating a new therapeutic paradigm aimed at slowing or even halting Parkinson’s disease progression. This project not only completes our first full translational cycle from differentiated early-stage research to clinical validation but also elevates Shanghai’s leadership in innovative neuroscience drug development. We are committed to advancing to Shanghai Zhangjiang’s vision as a global hub for biomedical innovation.”
Parkinson’s disease affects more than ten million patients globally, yet there remains no approved therapy that can slow or halt its progression. The targeted protein degradation strategy exemplified by PDR-001 offers a novel therapeutic approach not only for Parkinson’s but also for a broader range of neurological disorders. While the path ahead is long, the launch of this study represents a firm step forward in the Prodegre’s pursuit of the goal: causal treatment.
Founded in early 2024 in Shanghai with its initial financing, Prodegre Pharmaceutical is a biotechnology company focused on pioneering novel protein-degradation mechanisms and innovative therapeutic modalities. The company’s Prodegre Atlas™ platform integrates rational degrader design with translational medicine capabilities to develop differentiated degraders for central nervous system (CNS) and inflammatory diseases. PDR001—a world’s firstinclass peptidebased degrader—is now in clinical development, while a pipeline of rationally designed oral molecular glues and novel degraders advancing through preclinical development.
Xu Jingzhao, Vice president and Head of Finance, noted, “Prodegre firmly believes in the long-term clinical and commercial potential of protein-degradation technology in neurodegenerative, neuroinflammatory and autoimmune disorders. By leveraging Shanghai’s rich ecosystem of research talent, clinical infrastructure, and investment capital, we are building a globally competitive neuroscience-focused degradation platform to drive a pipeline of first-in-class candidates toward patients worldwide.”
PDR-001 is the world’s first peptide-based protein degrader to enter human studies. Its design utilizes a non-CRLIM-mediated degron to selectively clear pathological proteins. Preclinical models have shown pronounced efficacy, supporting its potential as a safe, durable treatment for early-to moderate-stage Parkinson’s disease.
Directly Targeting the Underlying Pathology of Parkinson's in Building a Long-Acting “Cell Factory”
Traditional Parkinson’s therapies primarily supplement dopamine to alleviate motor symptoms without slowing disease progression. PDR-001 is designed to directly target the underlying pathology of Parkinson's: abnormally aggregated α-synuclein. Through local stereotactic injection, an AAV vector carrying a specific peptide sequence turns infected cells into “cell factories” that continuously express the therapeutic peptide. This strategy addresses the short half-life typical of peptide drugs, enabling sustained expression from a single administration. The local injection dose is 1-2 orders of magnitude lower than systemic delivery, significantly reducing AAV-associated hepatotoxicity and immunogenicity risks.
Innovative Mechanism: A Differentiated Three-Domin Peptide Degradation Model Expands the Druggable Space for Protein Degraders
The uniqueness of peptide-based degraders lies in their rationally designed three-domain architecture. A TAT transmembrane domain allows the peptide to efficiently cross the blood-brain barrier and cell membranes, while a targeting peptide region enables high-specificity target recognition. The degradation domain can be designed based on the N/C-end rule pathway to incorporate Degron signal peptides. This approach overcomes the current heavy reliance of protein degraders on CRBN, dramatically expanding the potential target space for degraders.
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PDR-001, the world's first new drug for Parkinson's disease, has launched clinical trials and completed the first enrollment! The drug uses an innovative peptide degradation structure and targets the core pathogenic protein α-synuclein, which is an important breakthrough in the field of neuroscience. As the CRO of this project, SDM is honored to be deeply involved and looks forward to continuing to work closely with all parties to jointly promote the early launch of this innovative treatment originally developed in China and benefit patients around the world!
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