Proprietary Platform with Multiple Benefits
Biosys Health’s proprietary vaccination of farm animals to produce orally administered polyclonal antibodies and support gut microbiome has several key advantages:
(i) Supports healthy microbiome with specific pathogen targeting: antibodies bind to specific gut / mucosal pathogens leaving normal gut flora untouched, reducing relapse rates and supporting a healthy gut microbiome
(ii) Low risk of resistance: polyclonals are hard for pathogens to evade
(iii) GRAS (generally recognised as safe) status: naturally derived product that has a strong safety profile confirmed by a study in over 70 patients with a 46 day follow-up period
(iv) Production during normal lactation: proprietary vaccination method allows production during normal lactation and is, therefore, not reliant on low volume / high cost colostrum
C. difficile associated diarrhoea
The opportunity for C. difficile associated diarrhoea is large as almost half a million patients are diagnosed with C. difficile infection (CDI) each year in the US, with similar numbers in Europe, and most are treated with antibiotics. The Biosys Health product will be positioned to reduce relapse across several strains in a market where the economic burden of CDI is $6.3 billion in the US, and 29,000 US patients die annually (greater than MRSA and MDR Gram negative infections combined). Beyond the lead C. difficile product, the Biosys Health platform could generate oral polyclonal antibodies against other gut or mucosal pathogens with applications in the gastrointestinal space (e.g. Salmonella, Campylobacter infection) and beyond (brain health, metabolic disorders).
Biosys Health targets C.difficile cell surface proteins to interfere with the colonisation of spores and bacteria that cause relapse, as well as toxin A and toxin B that cause clinical symptoms and disease pathologies.
Efficacy has been demonstrated in two human pilot studies
- First study (n=16), no patients relapsed when taking Biosys Health's product
- Larger study (n=101) showed a relapse rate of < 10% with improvement of up to 83% (versus 25% to 60% for current standard of care)
Next step: pivotal clinical trial
Biosys Health has patents which protect the unique vaccination method which enables farm animals to produce high titre antibodies during normal lactation, as well as the process by which raw milk is converted into the final product.
1: Numan SC, Veldkamp P, Kuijper EJ, van den Berg RJ, van Dissel JT. Clostridium
difficile-associated diarrhoea: bovine anti-Clostridium difficile whey protein to
help aid the prevention of relapses. Gut. 2007 Jun;56(6):888-9. PubMed PMID:
17519495; PubMed Central PMCID: PMC1954844.
2: van Dissel JT, de Groot N, Hensgens CM, Numan S, Kuijper EJ, Veldkamp P, van
't Wout J. Bovine antibody-enriched whey to aid in the prevention of a relapse of
Clostridium difficile-associated diarrhoea: preclinical and preliminary clinical
data. J Med Microbiol. 2005 Feb;54(Pt 2):197-205. PubMed PMID: 15673517.
3: Young KW, Munro IC, Taylor SL, Veldkamp P, van Dissel JT. The safety of whey
protein concentrate derived from the milk of cows immunized against Clostridium
difficile. Regul Toxicol Pharmacol. 2007 Apr;47(3):317-26. Epub 2007 Feb 12.
PubMed PMID: 17293018.