Periodic Reporting for period 1 - PermeAbility (PermeAbility - A non-invasive, side-effect-free diagnostic kit for intestinal disorders)
Période du rapport: 2018-08-01 au 2019-01-31
Intestinal permeability or Leaky Gut Syndrome is the rupture of the gut wall leading to openings. Through these gaps malign components cross to the bloodstream and harm any internal organ. It is an early indication of several diseases where Inflammatory Bowel Disease (IBD) is very prominent. There is a serious problem on IBD diagnosis that relies on indirect or very invasive methods. Four million people are at risk and shocking data point 35% of surgeries to reveal unnecessary due to poor detection. Lifetag will fill this gap with a diagnostic kit to measure intestinal permeability as a direct market of gut wall lesions. It will improve precision and reduce the massive IBD health burden.
Proof of concept, IP and regulatory framework are fitted. Scale-up objectives rely on:
• International GAP analysis
• clinical development strategy
• clinical implementation and early adoption
• outsource of GMP/CMC/stability testing
• Gathering of KOL’s and distributors
• Market research
• partners for companion diagnostics
• Business plan refinement
• investors targeting
Recently, worked with a European CRO; started settlement of a medical board; identified CMP/CMC providers; granted business advisory; investment journeys; prospected business and clinical partnerships
Proof of concept, IP and regulatory framework are fitted. Scale-up objectives rely on:
• International GAP analysis
• clinical development strategy
• clinical implementation and early adoption
• outsource of GMP/CMC/stability testing
• Gathering of KOL’s and distributors
• Market research
• partners for companion diagnostics
• Business plan refinement
• investors targeting
Recently, worked with a European CRO; started settlement of a medical board; identified CMP/CMC providers; granted business advisory; investment journeys; prospected business and clinical partnerships
During SME Phase I different milestones were achieved:
• Work with EU CRO – Protherax Ltd (UK): GAP analysis confirming EU drug designation. Draft of Clinical Development Plan
• Product formulation: with Avivia, Ltd (NL) and Concept Life Sciences (UK) designing GMP/CMC/stability testing were designed and budgeted
• Medical Board/KOL’s: meetings with CEMBE – Fac. of Medicine, U. Lisbon (PT) for medical board and study of clinical/economic impact
• Discussions with J&J Innovation (EU): for business and clinical partnering
• Business development: Agreement with HiSeedTech (PT) for long-range work on all business lines
• Funding Seeking: Pitch in EU and US events
• Work with EU CRO – Protherax Ltd (UK): GAP analysis confirming EU drug designation. Draft of Clinical Development Plan
• Product formulation: with Avivia, Ltd (NL) and Concept Life Sciences (UK) designing GMP/CMC/stability testing were designed and budgeted
• Medical Board/KOL’s: meetings with CEMBE – Fac. of Medicine, U. Lisbon (PT) for medical board and study of clinical/economic impact
• Discussions with J&J Innovation (EU): for business and clinical partnering
• Business development: Agreement with HiSeedTech (PT) for long-range work on all business lines
• Funding Seeking: Pitch in EU and US events
Prospected results/impact:
• clinical data generation to better assign gut permeability to IBD patient classes
• pipeline product – algorithm using clinical data to prevent and assess disease stage
• Improve therapeutic decisions
• Prevention/screening – reduction of chronic disease onset and progression
• closer disease monitoring and patient’s life improvement
• reduction of current 35% unnecessary surgeries
• Attenuation on IBD economic burden - € 5.6B in EU and $ 6.2B in USA
• A new routine and high-throughput analysis. a commodity on health systems and reimbursement plans
• clinical data generation to better assign gut permeability to IBD patient classes
• pipeline product – algorithm using clinical data to prevent and assess disease stage
• Improve therapeutic decisions
• Prevention/screening – reduction of chronic disease onset and progression
• closer disease monitoring and patient’s life improvement
• reduction of current 35% unnecessary surgeries
• Attenuation on IBD economic burden - € 5.6B in EU and $ 6.2B in USA
• A new routine and high-throughput analysis. a commodity on health systems and reimbursement plans