{"id":9087,"date":"2025-01-13T08:00:57","date_gmt":"2025-01-13T13:00:57","guid":{"rendered":"https:\/\/www.bluerocktx.com\/?p=9087"},"modified":"2025-01-13T06:57:05","modified_gmt":"2025-01-13T11:57:05","slug":"bluerock-therapeutics-advances-investigational-cell-therapy-bemdaneprocel-for-treating-parkinsons-disease-to-registrational-phase-iii-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.bluerocktx.com\/bluerock-therapeutics-advances-investigational-cell-therapy-bemdaneprocel-for-treating-parkinsons-disease-to-registrational-phase-iii-clinical-trial\/","title":{"rendered":"BlueRock Therapeutics advances investigational cell therapy bemdaneprocel for treating Parkinson\u2019s disease to registrational Phase III clinical trial"},"content":{"rendered":"<ul>\n<li><span data-contrast=\"auto\">Phase III exPDite-2 trial follows completion and discussion of Phase I trial data with US FDA under Regenerative Medicine Advanced Therapy (RMAT) designation<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559685&quot;:357,&quot;335559740&quot;:360,&quot;335559991&quot;:357}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">exPDite-2 is a randomized, sham surgery-controlled double-blind trial assessing efficacy and safety of bemdaneprocel in people living with moderate Parkinson\u2019s disease<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559685&quot;:357,&quot;335559740&quot;:360,&quot;335559991&quot;:357}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Expected to be initiated in H1 2025, exPDite-2 is the first registrational Phase III clinical trial for an investigational allogeneic pluripotent stem cell derived therapy to treat Parkinson\u2019s disease<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559685&quot;:357,&quot;335559740&quot;:360,&quot;335559991&quot;:357}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><b><span data-contrast=\"auto\">Berlin, Germany, and Cambridge, MA, USA, January 13, 2025 <\/span><\/b><span data-contrast=\"auto\">\u2013 Bayer AG and BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced plans to initiate a Phase III clinical trial for bemdaneprocel, its investigational cell therapy for Parkinson\u2019s disease. The registrational trial, named exPDite-2, is expected to begin in the first half of 2025 and will represent a significant milestone in the development of allogeneic cell-based therapies for neurodegenerative disorders.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u201cWe are thrilled to take this critical step in our development program towards further investigating a potential new therapeutic option for people living with Parkinson\u2019s disease,\u201d said Amit Rakhit, MD, MBA, Chief Development and Medical Officer at BlueRock Therapeutics. \u201cexPDite-2 is the first registrational Phase III clinical trial for an investigational pluripotent stem cell derived therapy in Parkinson\u2019s disease and we look forward to working closely with clinical investigators and the Parkinson\u2019s disease community as we initiate this trial.\u201d<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In a Phase I study with 12 participants, bemdaneprocel demonstrated tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. Building on these results, exPDite-2 is a double-blind trial that will assess the efficacy, safety and overall impact of bemdaneprocel compared to a sham surgery control. The trial is designed to enroll approximately 102 participants with moderate Parkinson\u2019s disease. The primary endpoint of the study is change from baseline to week 78 in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day. In addition, the trial will incorporate secondary endpoints designed to capture objective measures of movement, safety and tolerability, and instruments that capture activities of daily living and quality of life.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The advancement to this registrational trial follows discussions with the U.S. Food and Drug Administration (FDA) under the Regenerative Medicine Advanced Therapy (RMAT) designation granted by the FDA in May 2024.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u201cWith the planned initiation of the Phase III clinical trial, we are committed to bringing bemdaneprocel faster to patients in need,\u201d said Christian Rommel, Member of the Executive Committee of Bayer\u2019s Pharmaceuticals Division, and Global Head of Research and Development. \u201cIt represents a significant milestone in our efforts to advance our cell and gene therapy pipeline and deliver on our ambition to be an industry leader in this space.\u201d<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Depending upon the outcome, the results from this trial are intended to be part of a robust data package to support regulatory submissions for marketing authorization.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">About bemdaneprocel (BRT-DA01)\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson\u2019s disease. These dopaminergic neuron precursors are derived from pluripotent stem cells that are human embryonic stem cells developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson\u2019s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson\u2019s disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. Data from the Phase I trial\u2019s 12 participants presented at the 2024 International Congress of Parkinson\u2019s Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. These participants continue in the long term Continued Evaluation Study. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">About Parkinson\u2019s disease<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Parkinson\u2019s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person\u2019s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the world\u2019s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options lack the holistic management of symptoms so new therapies are needed.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">About BlueRock Therapeutics LP<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological, ophthalmic, cardiovascular and immunological diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson\u2019s disease and OpCT-001 for the treatment of primary photoreceptor disease are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is expected to begin a Phase III clinical trial in H1 2025. OpCT-001 is expected to begin Phase I clinical testing in H1 2025. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell &amp; Gene Therapy platform. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">About Bayer<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, \u201cHealth for all, Hunger for none,\u201d the company\u2019s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&amp;D expenses before special items amounted to 5.8 billion euros. For more information, go to <\/span><a href=\"http:\/\/www.bayer.com\/\"><span data-contrast=\"auto\">www.bayer.com<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Contact for media inquiries Bayer:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Dr. Imke Meyer, phone +49 (214) 3021253<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Email: <\/span><a href=\"mailto:imke.meyer@bayer.com\"><span data-contrast=\"none\">imke.meyer@bayer.com<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Contact for investor inquiries:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Bayer Investor Relations Team, phone +49 214 30-72704<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\"><br \/>\n<\/span><span data-contrast=\"auto\">Email: <\/span><a href=\"mailto:ir@bayer.com\"><span data-contrast=\"none\">ir@bayer.com<\/span><\/a><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.bayer.com\/en\/investors\/ir-team\"><span data-contrast=\"none\">www.bayer.com\/en\/investors\/ir-team<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Find more information at <\/span><a href=\"https:\/\/pharma.bayer.com\/\"><span data-contrast=\"none\">https:\/\/pharma.bayer.com\/<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\"><br \/>\n<\/span><span data-contrast=\"auto\">Follow us on Facebook: <\/span><a href=\"http:\/\/www.facebook.com\/bayer\"><span data-contrast=\"none\">http:\/\/www.facebook.com\/bayer<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Contact for media inquiries BlueRock Therapeutics:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><b><span data-contrast=\"auto\">Jeff Lockwood, phone +1 (617) 510 6997\u202f<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Email: <\/span><a href=\"mailto:jlockwood@bluerocktx.com\"><span data-contrast=\"none\">jlockwood@bluerocktx.com<\/span><\/a><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Find information at <\/span><a href=\"http:\/\/www.bluerocktx.com\/\"><span data-contrast=\"none\">www.bluerocktx.com<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\"><br \/>\n<\/span><span data-contrast=\"auto\">Follow us on LinkedIn: <\/span><a href=\"http:\/\/www.linkedin.com\/company\/bluerocktx\"><span data-contrast=\"none\">www.linkedin.com\/company\/bluerocktx<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:1,&quot;335559740&quot;:360,&quot;469777462&quot;:[1418],&quot;469777927&quot;:[0],&quot;469777928&quot;:[1]}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Forward-Looking Statements<\/span><\/b><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer\u2019s public reports which are available on the Bayer website at <\/span><a href=\"http:\/\/www.bayer.com\/\"><span data-contrast=\"auto\">www.bayer.com<\/span><\/a><span data-contrast=\"auto\">. The company assumes no liability whatsoever to update these forward-looking statements or to conform<\/span> <span data-contrast=\"auto\">them to future events or developments.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Phase III exPDite-2 trial follows completion and discussion of Phase I trial data with US FDA under Regenerative Medicine Advanced Therapy (RMAT) designation\u00a0 exPDite-2 is a randomized, sham surgery-controlled double-blind trial assessing efficacy and safety of bemdaneprocel in people living with moderate Parkinson\u2019s disease\u00a0 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7775,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[52,57,61],"class_list":["post-9087","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-releases","tag-announcement","tag-clinical-trials","tag-parkinsons-disease"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BlueRock Therapeutics advances investigational cell therapy bemdaneprocel for treating Parkinson\u2019s disease to registrational Phase III clinical trial - BlueRock Therapeutics LP<\/title>\n<meta name=\"description\" content=\"BlueRock will initiate a Phase III clinical trial for bemdaneprocel, its investigational cell therapy for Parkinson\u2019s disease. 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