2021-08-002 + 2019-06-002 + 2019-05-005 - MetalA-MDR 05 - New metal-antibiotics against multidrug-resistant bacteria

MetalA-MDR 05

2021-08-002 + 2019-06-002 + 2019-05-005

Develop the hit to lead phase of this new antibiotic in order to achieve a compound for the preclinical phase.. We have obtained a HIT, UAL267, of a new chemical class antibiotic active against multi-drug resistant bacteria Gram+, Gram –, including WHO ESKAPE priority pathogens

We estimate that our solution would reduce 25% of all deaths due to wounds and SSTIs (Skin and Soft Tissue infections) caused by MRSA (9,000 deaths in the US per year).

Infections caused by MDR are a huge problem for humanity. Since the discovery of the first beta-lactams (such as penicillin), researchers have been very productive in designing and synthesizing new antibiotics, but, in the last 20 years, the pipeline has become dry of new molecules. Additionally, the bacteria has developed resistance to many drugs available for clinical use, compromising plenty of routine clinical procedures, such as cancer treatment or hospitalization. The burden of this threat is reaching a tipping point where doctors will not know how to treat certain types of infections. The discovery and development of new drugs, such as our metalloantibiotics, could revolutionize the clinical practice because it is a new antibiotic chemical class with a low likelihood of presenting resistance in the long term.

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Our business model is based on creating a spin-off company to develop the asset until the early clinical phases. Then, try to sell it to a well-established pharma company which will pay an upfront payment and for certain milestones achieved.

The antibiotic market is very controversial. On the one hand, the unmet need is very clear, but, on the other hand, there are few incentives for pharma companies to launch a product in the market because doctors and clinicians will not use them until they will strictly need it. So the perspectives of a return on investment are not very good. Fortunately, spin-off companies and small and medium enterprises are taking the lead in the development of innovative antibiotics, but there must be adittional incentives from governments and policymakers that must value antibiotics by the value they own and not by the volume of sales.

We are currently focusing on the market of wound healing, where infections caused by resistant bacteria are raising dramatically and the currently available options are not good enough to cover the need and present some safety issues. Our solution represents a new class of antibiotic which fulfils all the WHO recommendations for a new antibiotic. Our priority is in Western Europe, the USA and China, countries where the patent has been granted or is in prosecution, and where the cases of wound infections are becoming an increasing threat.

We are now at TRL 3, finishing the Hit-to-Lead phase, trying to find a suitable lead to be encapsulated and to perform some in vivo validation in 1-2 years. We have calculated and we will need 1-1.5M€ to take the lead to the preclinical phase. There, we will need an additional 1.5M€ to perform the preclinical studies. We have planned to submit several competitive funding proposals, non-dilutive and dilutive once the spin-off is created, to carry out the development.

Partnership with the industry (Shionogi, Debiopharm) Competitive funding

In three months, we would like to have performed the validation in vivo of the lead encapsulated in liposomes for topical adminstration

Our new metalloantibiotic represents a new chemical class, with a broad spectrum activity (active against Gram-negative and Gram-positive bacteria). If approved, it would be the first class of a metalloantibiotic to be used as an antibiotic, opening the door to other drugs based on metals, to follow the same path. The last chemical class approved is dated in the 1980s, and the developed drugs since then are based on already existing antibiotics, which are more prone to generate resistance. The current metealloantibiotic presents high levels of synergy with amikacin and colistin The bacteria are not able to generate resistance after 30 days

Lengthy pathway to approval High cost and low success rates It currently takes approximately 10 years to progress an antibiotic candidate from the preclinical to the clinical stages

The patent has been granted in six European countries, the UK, Mexico, India, the USA, China, Japan and Brazil. It is still in prosecution in Canada. The patent is a product patent, protecting the gold (III) complexes and their antimicrobial activity.

The patent has been granted in six European countries, the UK, Mexico, India, USA, China, Japan and Brazil. The patent is still in prosecution in Canada We have signed an agreement for five years with the National Institute of Allergy and Infectious Diseases (NIAD) to use its preclical services without cost We have reached out a lot of potential pharma companies, but they want to see the issue around toxicity solved and strong in vivo evidence by topical administration

Know-how on microbiology and organometallic chemistry

Patents: EP3564246A1 - Date: Nov 6th, 2019 Status: Granted URL: https://patents.google.com/patent/EP3564246A1/en

The fact that antimicrobial resistance is a global health crisis, the lack of a robust new antibiotics pipeline and the competitive advantage of our technology makes it a priority investment with very positive social and market outlooks.