D121

D121 is a member of the alkylphosphocholines family. Alkylphosphocholines are known for their antiproliferative action. The different analogs have high potential as treatment candidates against multiple diseases including cancer, parasitic infections, bacterial infections, fungal diseases, multiple sclerosis and psoriasis. D121 is considered to be a new chemical entity and a promising candidate to respond to critical unmet medical needs in animal and human health: Leishmaniasis, Chagas Disease, Cryptosporidium infection and Invasive Fungal Infections (IFIs).

Leishmaniasis, Chagas Disease and Cryptosporidium infection are human parasitic infections and IFIs are a group of fungal infections that primarily affect immunocompromised patients. All are potentially lethal if not treated well and are characterized by urgent unmet medical needs as current treatment options for these diseases are largely inadequate. Current pre-clinical and phase 1 data show that D121 has a significantly bigger therapeutic window of safety than the current state-of-the-art oral treatment against Leishmaniasis. Furthermore, convincing in vitro and in vivo preclinical results on the effectiveness of D121 against Chagas Disease and Invasive Fungal Infections that have become multidrug resistant have been documented, and show the potential of this compound to treat these indications.

The first three indications are orphan diseases and the latter one is not only a potential block buster. With an orphan-drug market strategy, D121 can become a major block-buster while being developed at limited costs and limited risks. In this way, both the commercial potential as well as the curative potential for these diseases impacting public health are fully leveraged.

For Canine Leishmaniasais, D121 shows significant competitive advantages over existing current treatments to alleviate suffering of the dog and improve his quality of life without relapsing within 3 months. Strong pharmaceutical development for Canine Leishmaniasis will have huge spill-over effects on the further development possibilities for any other disease indication, human or animal, of D121. Market authorization for Canine Leishmaniasis is the “low hanging fruit”.

Pipeline Animal Health

Canine Leishmaniasis

TRL 1 & 2 TRL 3 TRL 4 TRL 5 TRL 6-7 TRL 8 TRL 9
Concept Start PoC Preclinical (toxicology and safety) Clinical Development (pivotal safety & efficacy study in targeted animal species) Regulatory (filing & approval) Marketing Authorisation

 

Cryptosporidiosis Parvum

TRL 1 & 2 TRL 3 TRL 4 TRL 5 TRL 6-7 TRL 8 TRL 9
Concept Start PoC Preclinical (toxicology and safety) Clinical Development (pivotal safety & efficacy study in targeted animal species) Regulatory (filing & approval) Marketing Authorisation

 

Pipeline Human Health

Indication preclinical Phase I Phase II Phase III NDA (FDA) and/or MA (EMA)
Cutaneous and muco- leishmaniasis      
Visceral leishmaniasis      
Chagas disease      
Invasive fungal infections