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Bacterial Resistance: Atlangram’s solution in 15 key points
1. Antibiotic Resistant infections kill more than 700,000 people each year; any novel antibiotic class was discovered in the past 30 years,
2. Resistance particularly affects Bone and Joint Infections (BJI): osteomyelitis, fracture-associated infections, prosthetist infections, septic arthritis etc.
3. A prolonged hospitalization with surgery and intravenous antibiotic therapy are generally required,
4. Daptomycin represents one of the major antibiotics used, but its administration is exclusively by IV route which causes side effects and needs a minimum of one administration per day for 2 weeks.
5. Despite this, BJI have significant rates of treatment failures and complications (20-30%) and the mortality is around 4.6 % and 40% to 50% of patients present residual joint dysfunction after BJI.
It is for these reasons ATLANGRAM opted to develop a local application of Daptomycin, Daptogel, to maximize its efficacy and minimize its toxicity & resistance induction.
6. A nanotechnology enabling gel formulation for local intraoperative application and prolonged delivery of the last-generation antibiotic’s Daptomycin to prevent and cure BJI,
7. Daptogel guarantees a long lasting high local antibiotic concentration, which eradicates bacteria up to 14 days without any resistance following a SINGLE administration,
8. Known and existing components: Daptogel is composed of Daptomycin (commercialized in 2001; generic in 2016) encapsulated in FDA approved biodegradable lipid nano-particles and excipients; no additional medical and/or surgical act is needed (the gel is applied during bone surgery to foster healing),
9. Daptogel will reduce resistance by respecting microbiota and antibiotics intravenous administration, and will reduce costs linked to hospitalization, medical personnel during the treatment as well as risks linked to nosocomial secondary infections,
10. Daptogel is patented (2019) & obtained 4 “Seals of Excellence” by the jury of UE Commission, and supported by BJI French Reference Centers.
11. The world BJI market was near $1.7 Bn in 2016 with annual growth rate of 8.1% between 2009 and 2016. There are currently more than 3 million total joint replacement in the U.S & Europe annually, with an infection risk of 1-3 %, and a recurrence rate of 20–30%.
12. The present business innovation project will bring Daptogel up to preclinical regulatory scale-up & safety demonstration (duration: 18 months) and early stage clinical application (phase IIa trial, duration: 18 months),
13. ATLANGRAM is seeking financing in a current round in the order of €5 M to complete Daptogel preclinical (€2 M) and early clinical development (€3 M). The steps below summarize which studies are required:
-Completing Preclinical Development, year 1&2 (GMP compliant scale-up manufacturing; Safety and analytical studies.
-Submitting to regulatory authorities to initiate clinical trials, year 2
- Initiating and completing clinical phase IIa study (30 patients), year 3&4.
14. ATLANGRAM strategy is to establish commercial partnership with key pharmaceutical industry stakeholders by licensing or having the start-up company acquired at a phase IIa clinical stage. An early exit through M&A or IPO is anticipated by H1 2024,
15. A licensing deal in 2024 with a minimum upfront of €25 M. Additional milestones with royalties will come when Daptogel will reach clinical (phases IIb & III in 2025-2027), then commercial (royalties in, 2028-2043) stages. To reach new markets / increase market share, we will apply the technology to several antibiotics with additional licensing deals.
Amokrane REGHAL, MD-Microbiologist. CEO and co-founder of ATLANGRAM. FRANCE firstname.lastname@example.org