Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - Sea4Pain (Development of a novel analgesic for chronic pain from marine-derived compounds)

Teaser

Chronic pain is a global problem for which currently there is no adequate solution. Although treatments for mild pain are effective, the medication used in cases of moderate to severe chronic pain may provide a pain relief but causing strong side effects such as nausea and...

Summary

Chronic pain is a global problem for which currently there is no adequate solution. Although treatments for mild pain are effective, the medication used in cases of moderate to severe chronic pain may provide a pain relief but causing strong side effects such as nausea and dizziness, as well as habituation. In fact, despite a variety of treatment options, as many as 40% of patients treated for chronic pain do not attain adequate relief. In addition, opioids, a class of drugs traditionally used to control severe pain, cause dependence (since they are involved in the reward circuits of the brain), as well as effects in cognitive properties, motivation and mobility.
Chronic pain is any prolonged pain lasting more than 3-6 months or persisting after a natural recovery period. It derives from several clinical diagnoses, including diabetes, arthritis, migraines, fibromyalgia, cancer, back pain, zona, sciatica, neuropathic pain and phantom limb pain.It is a huge burden for world economics and society, affecting at least 21% of the world’s population. This number is highly likely to increase due to the global demographic trends such as aging population. Chronic pain can cause disability, leading to an enormous social and economic burden, and for which there is still no adequate treatment. Over $635 billion are lost every year in the USA due to salary losses, low productivity and health care costs, with similar figures in Europe. An innovative drug that would have less side effects than opioids and wouldn’t cause addiction, could contribute to prevent such losses, thus presenting a clear business opportunity. The global pain management drugs and devices market was estimated to be worth $58.6 billion in 2016 and reach $77.1 billion in 2023 at a CAGR of 4%.
The scientific and technological approach of Sea4Us is highly disruptive compared to the current pain treatment solutions. The first Sea4Us’s lab-based research results have demonstrated the clear benefits of marine-derived compounds, yet synthesisable, in a series of pathologies, like chronic pain, and the huge potential of its derivate products in the health market. In particular, our innovative breakthroughs will lead to the development of a unique, high efficacy analgesic for patients suffering from moderate to severe chronic pain (ion channel modulator), with reduced toxicity and limited side-effects: Sea4Pain.
The overall objectives for this Phase I consisted in: 1) Technological Feasibility Study, 2) Market Assessment, 3) Business Model Assessment, 4) Risk Assessment, 5) IP Assessment, 6) Work Plan for Phase 2.

Work performed

The work that has been completed during this period covered by the report is summarized as follows:
- We performed additional pre-clinical validation, including further efficacy and toxicity tests, new efficacy tests leading to extra pain indications, and defined the next steps for pharmacokinetic/pharmacodynamic (PK/PD) studies, clinical trial application to the regulatory authorities, and clinical trials.
- We studied the market in detail by updating the size, growth, segmentation and other aspects. We contacted additional potential clients and/or partners.
- We further explored the best business model for the Sea4Pain go-to-market, including out-licensing of compounds (which may occur at different stages of product development), co-development strategies, or even a complete product development in the case of a very large investment round.
- We conducted risk assessments for Sea4Pain including likelihood, impact and contingency plans.
- We continued our intellectual property strategy, including the preparation of international patents (molecule and therapeutic applications, modes of action, synthesis methods) and the Freedom to Operate studies.
- We drafted a Work Plan for SME Instrument Phase 2 including Gantt chart, work packages, tasks, deliverables, milestones and staff effort estimations. Altogether, during the Phase I feasibility study we had the opportunity to perform additional preclinical tests, define the next steps of product development including clinical trials, and to contact several different potential partners, investors and buyers for our patents.We have confirmed the interest of these stakeholders in our products and we are now establishing partnerships with consultants that will allow us to obtain the best investment deals, obtain the best deals for selling our patents, and determine until which phase we should take our project before out-licensing our patents. The technical and commercial activities described will also allow us to identify the best therapeutic application for our product, between the various pain models already tested.

Final results

\"The Sea4Pain project expanded and defined the development strategy for Sea4Us’s “Drug Discovery and Development Platform” – a platform that applies novel biotechnological approaches to exploit marine derived compounds for the development of novel pharmaceuticals highly relevant for biomedicine.
Our extremely innovative approach for chronic pain treatment shows a differentiated mode-of-action (acting directly in the \"\"pain switch\"\"), that will give rise to a new class of pharmaceutical drugs with no expected adverse effects on the brain. The disruptive compound will modulate specific ion channels in pain-sensing neurons (Kv), for which there is no known modulator, and ease the suffering of one fifth of the World\'s population who constantly suffer from chronic pain.
Founded in 2013, Sea4Us has received over 635.000€ in Portuguese and European Research Grants, raised 10.000€ with crowdfunding, and 750.000€ in venture capital, supporting a team of 13 professionals and is focused on developing the Sea4Pain roll-to-market of innovative treatments.The technical and market analysis carried out during this Phase 1 has demonstrated the viability of the technology to reach the market by confirmation of the interest from potential partners, consultants, investors and clients, who will all be addressed within the Phase 2 project execution.
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Website & more info

More info: http://sea4us.pt/en/.