Sea Pharmaceuticals Advances CNS Treatments with Strategic Partnerships

Sea Pharmaceuticals, a biotech company based in Cambridge, MA, has announced strategic collaborations with Inotiv Inc. and TCG GreenChem, Inc. to advance its pre-clinical neurotherapeutic molecules targeting central nervous system (CNS) disorders. The partnerships focus on the development of Sea's lead molecule, SPM-0404, a potential oral treatment for tinnitus, epilepsy, and sporadic ALS (S-ALS). These collaborations are poised to enhance the development and potential market success of SPM-0404 and its second-generation molecule, SPM-0606, by leveraging the expertise of Inotiv and TCG GreenChem in IND-enabling studies and CMC development, respectively.

The biotech industry is experiencing a transformative phase in 2024, with a boom in mergers and acquisitions and a resurgence of initial public offering activities. M&A activity is on track to surpass last year if the current trend continues, while funds raised via U.S. IPOs for biotech have also significantly increased compared to last year. This trend underscores a rejuvenated market enthusiasm and investor confidence, which could benefit Sea Pharmaceuticals as it advances SPM-0404 through the development pipeline.

Sea Pharmaceuticals has set several key milestones and timelines for the development of its lead molecule, SPM-0404, which is currently in investigational new drug (IND)-enabling studies. These milestones include pre-clinical development, CMC development, and the filing of an IND application with the FDA. The company's strategic collaborations with Inotiv and TCG GreenChem are designed to support these milestones and advance SPM-0404 into clinical trials.

The biotech industry is experiencing a transformative phase in 2024, with a boom in mergers and acquisitions and a resurgence of initial public offering activities. M&A activity is on track to surpass last year if the current trend continues, while funds raised via U.S. IPOs for biotech have also significantly increased compared to last year. This trend underscores a rejuvenated market enthusiasm and investor confidence, which could benefit Sea Pharmaceuticals as it advances SPM-0404 through the development pipeline.



Sea Pharmaceuticals' strategic collaborations with Inotiv Inc. and TCG GreenChem, Inc. significantly enhance the development and potential market success of SPM-0404 and SPM-0606 for treating CNS disorders through several key mechanisms. Inotiv Inc. is selected for pre-clinical development IND-enabling studies to support the advancement of Sea's lead molecule SPM-0404. Inotiv's expertise in these studies is crucial for assessing the safety and efficacy of SPM-0404, which is essential for filing an IND application with the FDA. Dr. John E. Sagartz, Inotiv's Chief Strategy Officer, highlights Inotiv's success in developing many safe and effective medicines approved worldwide, including development work on hundreds of IND molecules. This expertise positions Inotiv well to assist Sea in development strategy and to perform IND-enabling studies, thereby increasing the likelihood of successful regulatory approval.

Inotiv Inc. will also assist Sea to quantify SPM-0404 levels in Clinical Phase 1 and Ph.1b Trials. This quantification is vital for understanding the pharmacokinetics and pharmacodynamics of SPM-0404, ensuring that the molecule reaches therapeutic levels in the CNS and is safe for human use. This data is critical for the successful progression of SPM-0404 through clinical trials and eventual market approval.

TCG GreenChem, Inc. will conduct Chemistry, Manufacturing, & Controls (CMC) development on SPM-0404, producing the cGMP material for IND-enabling studies and for Clinical Trials. Chris H. Senanayake PhD, TCG GC Founder, CEO & CSO, and Joe D. Armstrong III PhD, chief business officer, have made over 500 IND molecules and several FDA-approved drugs in their combined 65 years in the pharma industry. Their expertise ensures that SPM-0404 is manufactured to the highest standards, meeting regulatory requirements and enhancing the molecule's chances of market success.

Sea's novel chemical composition of matter in separate filings is protected by a 100% Sea-owned patent estate. This intellectual property protection is crucial for preventing competitors from copying SPM-0404 and SPM-0606, thereby securing Sea's market position and potential revenue streams.

Sea's molecules act as selective dual AMPAR (AMPA receptor), KAINR (kainate receptor) antagonists (DAKAs). DAKAs dampen the activity of the excitatory neurotransmitter glutamate, which plays an important role in many physiological, neurological, and neurobehavioral functions. This targeted approach enhances the therapeutic potential of SPM-0404 and SPM-0606 for treating CNS disorders such as tinnitus, epilepsy, and ALS, where there are currently unmet medical needs.

In summary, the strategic collaborations with Inotiv Inc. and TCG GreenChem, Inc. provide Sea Pharmaceuticals with the necessary expertise, resources, and regulatory support to advance SPM-0404 and SPM-0606 through clinical development and towards market success. These partnerships are a crucial step for Sea in filing an IND application with the FDA, potentially bringing innovative oral treatments to patient populations with significant unmet needs.