Neuraly and Enigma Biomedical Form Partnership for PMI04

Neuraly Teams Up with Enigma Biomedical for Innovative Biomarker Development

Neuraly Inc., a dedicated subsidiary of D&D Pharmatech Inc., has proudly announced a collaborative venture with Enigma Biomedical USA, Inc. This significant partnership centers around PMI04, a groundbreaking PET imaging biomarker specialized in detecting neuroinflammation. The recent agreement marks a promising step toward improved diagnostics and future treatments for various neurodegenerative diseases.

Details of the Research License and Commercialization Option

Under the newly established agreement, Enigma obtains an exclusive research license for PMI04, along with the opportunity to negotiate the commercialization rights stemming from their research findings. PMI04 targets the colony stimulating factor 1 receptor (CSF-1R), which is prominently expressed in activated microglia. This specificity allows for a detailed visualization of microglial activity, offering crucial insights into conditions like Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis. Enigma is poised to direct its development efforts primarily toward addressing these neurodegenerative disorders.

The Advantages of PMI04 in Neuroimaging

Current neuroimaging techniques employing the translocator protein (TSPO) often yield limited specificity, complicating interpretations and quantitative analyses. By contrast, PMI04’s ability to selectively bind to activated microglia correlates directly with their proliferation and survival, marking a significant advancement in PET imaging. It presents an opportunity for effective quantification and early detection of inflammation-related neurodegenerative diseases, potentially leading to enhanced therapeutic strategies.

Future Outlook and Financial Implications

If the upcoming research proves successful, a subsequent commercialization agreement will formalize Enigma's exclusive rights for the ongoing development and marketing of PMI04. As part of this arrangement, Neuraly will receive initial payments and additional milestone payments tied to the progress of development and commercialization, alongside a share of future sales revenues once the product is on the market.

Statements from Leadership

Seulki Lee, CEO of Neuraly, expressed enthusiasm for the collaboration, stating, "This partnership is a significant milestone in our journey toward advancing diagnostics and treatment options for neurodegenerative diseases. We are dedicated to ensuring that PMI04 reaches the market swiftly through our close partnership with Enigma." Rick Hiatt, President and CEO of Enigma, echoed this sentiment, highlighting their commitment to leveraging successful previous experiences with neuroimaging biomarkers and asserting confidence that PMI04 will play a crucial role in developing effective therapeutic options for neurodegenerative conditions.

About Enigma Biomedical USA, Inc.

Enigma Biomedical USA aims to become a leading provider of innovative imaging biomarkers tailored for neurological disorders, along with the supporting information technology necessary for the swift development, approval, and integration of effective treatments for neurodegenerative diseases. By offering state-of-the-art neuroimaging biomarkers, Enigma equips pharmaceutical companies and academic researchers with the tools needed to develop disease-modifying therapies with unparalleled precision and accuracy. This objective is evident through their provision of notable PET imaging biomarkers such as MK-6240 and NAV-4694, recently secured by a third-party entity for further research and development initiatives.

About D&D Pharmatech, Inc. and Neuraly Inc.

D&D Pharmatech, Inc., listed on the KOSDAQ in Korea, focuses on developing GLP-1 receptor agonists. They are collaborating with the Johns Hopkins University School of Medicine on imaging biomarker developments related to neurodegenerative disorders. D&D is actively conducting clinical trials for GLP-1 treatments, including a recent Phase 2 trial concerning the weekly injectable GLP-1 receptor agonist pegsebrenatide (NLY01) targeting Parkinson’s disease.

Neuraly Inc. functions as D&D's wholly-owned subsidiary and specializes in IND-enabling studies and clinical advancements aimed at tackling neurodegenerative, metabolic, and fibrotic diseases. With a successful record of clearing multiple IND submissions and conducting several clinical trials, Neuraly is also managing an ongoing Phase 2 trial for metabolic dysfunction-associated steatohepatitis (MASH).

Frequently Asked Questions

What is the significance of the partnership between Neuraly and Enigma?

This partnership focuses on the development of PMI04, an advanced imaging biomarker aimed at improving diagnostics for neuroinflammatory conditions.

How does PMI04 differ from existing neuroimaging techniques?

PMI04 specifically targets activated microglia, offering higher specificity compared to traditional TSPO imaging, thus enhancing diagnostic accuracy.

What are the potential applications of PMI04?

PMI04 aims to assist in the diagnosis and monitoring of neurodegenerative diseases, including Alzheimer's and Parkinson's diseases, leading to better treatment options.

What financial arrangements accompany the agreement?

Neuraly will receive upfront and milestone payments, plus sales royalties upon PMI04’s commercialization, ensuring financial incentives aligning both companies' interests.

Who are the leaders of Neuraly and Enigma?

Seulki Lee is the CEO of Neuraly, while Rick Hiatt serves as the President and CEO of Enigma, both underscoring the importance of collaboration in developing neuroimaging solutions.

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