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Description
The Bluebiotech4Pain project aims to unleash marine resources for the treatment of diseases through marine biotechnology: the development of a marine-derived analgesic for chronic pain treatment, through an industrial biotechnological production process.Previous studies by Sea4Us have shown analgesic bioactivity from a molecule extracted from marine bacteria from Sagres, Portugal. The proof of concept revealed good levels of efficacy in animal models. This project consists in the optimization of the biotechnological production method of such compound (or of its variants), while maintaining or even improving its bioactivity, leading to the establishment of a scaled-up production method and the design of the business strategy. It is essential for taking the Sea4Us’s analgesic program to market: generate material to perform preclinical trials and engage into a licensing agreement with a large pharmaceutical company, which will then conclude drug development.The activities of this project include:Activity 1: Biotechnological production optimization, supported by chemical synthesis; strain and fermentation process development;Activity 2: Testing produced compounds by electrophysiology and in vivo assays for efficacy, as well as for other bioactivities and toxicity;Activity 3: Scaling up the optimized production process to a pilot scale;Activity 4: Filing of patents and designing the subsequent business strategy.In this project, NOVA Medical School (Lisbon, Portugal) will focus on microbiology and growth optimization, SINTEF (Trondheim, Norway) will work on strain and fermentation process development and scale-up, UiT The Arctic University of Norway (Tromsø, Norway) will use its expertise in bioactivity and toxicity testing, and Sea4Us will apply its knowledge of electrophysiology and in vivo assays, and also of intellectual property and pharmaceutical business.
Summary of project results
Sea4Us prospect the ocean to find differentiating chemistries for the treatment of unmet clinical needs. From the sea of Sagres (Portugal) they extracted a molecule from marine bacteria, with analgesic activity. It operates via a novel mode of action, blocking pain perception only in peripheral neurons actively engaged in pain sensing, not affecting “pain-free” ones.
Through Bluebiotech4Pain they identified a simplified version of the originally observed bioactive molecule. Its bioproduction was optimized to be high yield and sustainable. From the marine-inspired chemistry, they further developed 9 related molecules, to improve treatment efficacy and safety to patients. They tested the novel drugs for their synthesis viability, in vitro and in vivo analgesic effect and showed modulation of specific neuronal currents through electrophysiology assays. In vitro testing indicated low toxicity, and the potential for other medical applications.
The best compound was synthesised at a larger scale, to allow for further pre-clinical validation. It’s differentiating mechanism of action means it is effective at treating chronic pain and has no serious side effects, unlike current drugs on the market. Chronic pain constitutes a significant burden for the individuals affected by it. It has a profound impact on quality of life, physical and emotional wellbeing, and ability to work. It is the reason for 40 % of visits in primary care. 83 % of primary care providers cite time constraints as a limiting factor for optimal pain control. The primary care providers will access an adequate pain management treatment and reduce consultation burden. The patients, billions of people worldwide the suffering of pain, will access a safe and effective treatment.
Summary of bilateral results
The consortium has made significant advances towards the development of a non-opioid treatment of pain. Additional medicinal-chemistry and pre-clinical development will refine the IP strategy and lead to a patent draft and submission. Consortium members are highly motivated to push further. Activities wil be slower in the gap period between the EEA Grants support and securing of next funds, but the team is exploring the next possibilities ahead