The “One Health” approach emerged following the unprecedented global response to the highly pathogenic avian influenza in 2007, but the philosophy began years before.
This is an initiative intended to forge co-equal, all-inclusive collaborations between physicians, osteopaths, veterinarians, dentists, nurses and other scientific health and environmentally related disciplines. Nowadays, when the tendency in human health treatment is moving towards companion diagnostic and personalized medicine, it is surprising to find out about this initiative, resulting in a holistic approach to diseases.
Reading about participants in One Health, I have realized that several biotech companies are changing their strategies and making a commitment to veterinary medicines. In fact, some diseases, such as rheumatism, infection and even some cancers affect both humans and animals, while animal drugs have often come from repositioning human products or from human products that failed at the clinical stage rather than R&D as such. Nowadays we can see that companies are developing new products targeting animal health in the hope of moving the drug to human health at a second stage. I am thinking of Genebiotech, positioned in rheumatology for both animal and human health, and other biotechs such as Da Volterra or Antabio, which are addressing the threat of bacterial infections and antimicrobial resistance for humans and animals.
What makes the vet market so interesting? Basically, development costs are lower and income can be expected at an earlier stage. While for a human drug, an extensive toxicology study in two animal species is needed before moving to the clinic for 7 to 8 additional years, for animal health the second toxicology species used can be already the target species (corresponding to the clinical Phase 1 in human). Also, clinical trials for veterinary drugs are less expensive and can be conducted faster. Finally, veterinary drugs can reach the market as soon as 2 to 3 years following the inception of animal studies. In this case, the revenue produced by veterinary drug sales may serve as a way of generating an intermediate return on investment that fuels more expensive development in humans.
This strategy can be applied when your active compound is a small chemical molecule; not a biologic that specifically needs to be developed for the target species due to the immunogenicity risk. The target should also be conserved between species, or it could be external to the proper body as it is the case for parasitic or microbial infections.
This is the case of antibiotic, anti-parasitic, and even some anti-inflammatory or anti-cancer drugs. However, although it looks attractive, special care has to be taken with metabolism. Indeed, the differences in species metabolism can either be quantitative (same metabolic route but different rates) or qualitative (different metabolic routes). See below an example about the caffeine metabolism in different species:
Caffeine is metabolized in Paraxanthine, Theobromine, and Theophylline. The following table illustrates the metabolism differences between species (Berthou F. et al. (1992) Xenobiotica 22, 671-680)
Based on that, I would expect a drug to be optimized differently depending on whether the target species is human or an animal. So I presume there are two possibilities:
- These companies are optimizing the drug for humans and if by chance it shows activity in animals they will take advantage of the opportunity.
- They are optimizing it in animal species and the income will help finance development for humans, starting from lead optimization.
In both cases, the objective is to obtain a fast return on investment and a kind of proof of concept in vivo to attract investors or pharmaceutical companies. It may be worth thinking about, but, as usual, the companies need the right people, such as metabolism experts or vets if they do not want to lose more money than they expect to make.
"Mtazamo wa ""Usalama Mmoja"" ulitokea kufuatia majibu ya ulimwengu yasiyo na kifani kwa mafua ya ndege ya pathogenic sana mnamo 2007, lakini falsafa ilianza miaka mingi kabla ya hapo." Hii ni mpango wa kuunda ushirikiano wa usawa, wa pamoja kati ya madaktari, osteopaths, madaktari wa mifugo, madaktari wa meno, wauguzi na taaluma nyingine za kisayansi zinazohusiana na afya na mazingira. Leo, wakati mwelekeo katika matibabu ya afya ya binadamu unakwenda kwa matibabu ya utambuzi wa mwenzi na matibabu ya kibinafsi, ni ya kushangaza kujua juu ya mpango huu, na kusababisha mbinu ya jumla ya magonjwa. "Kama nilivyosoma kuhusu washiriki wa One Health, niligundua kwamba makampuni kadhaa ya biotech yanabadilisha mikakati yao na kufanya ahadi ya dawa za mifugo. """ Kwa kweli, magonjwa kama vile rheumatism, maambukizi na hata baadhi ya kansa huathiri wanadamu na wanyama, wakati dawa za wanyama mara nyingi zimetokana na kuhamisha bidhaa za binadamu au kutoka kwa bidhaa za binadamu ambazo zilishindwa katika hatua ya kliniki badala ya R&D kama hiyo. "Hata hivyo, kwa sasa, kampuni nyingi zinatengeneza bidhaa mpya kwa ajili ya afya ya wanyama, kwa matumaini ya kuweza kuitumia kwa afya ya binadamu katika hatua ya pili.""" "Tunaamini katika teknolojia ya ""biotech"" kama vile DaVolta, ambayo inashughulikia hatari ya maambukizi ya bakteria na upinzani wa antimicrobial kwa wanadamu na wanyama." Ni nini kinachofanya soko la mifugo liwe lenye kupendeza sana? Kimsingi, gharama za maendeleo ni chini na mapato yanaweza kutarajiwa katika hatua ya mapema. Kwa dawa za binadamu, utafiti mkubwa wa sumu katika spishi mbili za wanyama unahitajika kabla ya kuhamia kliniki kwa miaka 7 hadi 8, kwa afya ya wanyama, spishi ya pili ya sumu inayotumiwa inaweza kuwa tayari spishi ya lengo (yaani awamu ya kliniki ya kwanza kwa binadamu). Pia, majaribio ya kliniki ya dawa za mifugo ni ya bei nafuu na yanaweza kufanywa upesi zaidi. Dawa za wanyama zinaweza kuwasili kwenye soko baada ya miaka miwili au mitatu ya kuanza kwa majaribio ya wanyama. Katika kesi hii, mapato yanayotokana na mauzo ya dawa za mifugo yanaweza kutumika kama njia ya kuzalisha faida ya kati ya uwekezaji ambayo huchochea maendeleo ya gharama kubwa zaidi kwa wanadamu. Mkakati huu unaweza kutumika wakati kiungo chako cha kazi ni molekuli ndogo ya kemikali, sio biolojia ambayo inahitaji kutengenezwa kwa spishi ya lengo kwa sababu ya hatari ya immunogenicity. Mfano wa kuambukizwa ni kuwa ni hatari kwa binadamu, au inaweza kuwa nje ya mwili kama ilivyo kwa maambukizi ya vimelea au microbial. Hilo ni kweli kuhusu dawa za kuua viini, dawa za kupambana na vimelea, na hata dawa fulani za kuzuia uvimbe au za kupambana na kansa. Hata hivyo, ingawa inaonekana kuwa yenye kuvutia, ni lazima uangalie hasa kimetaboliki. Kwa kweli, tofauti katika kimetaboliki ya spishi inaweza kuwa ya kiasi (njia sawa ya kimetaboliki lakini viwango tofauti) au ya ubora (njia tofauti za kimetaboliki). Tazama hapa chini mfano kuhusu kimetaboliki ya kafeini katika spishi tofauti: Kofeini hubadilishwa kuwa Paraxanthine, Theobromine, na Theophylline. Jedwali lifuatalo linaonyesha tofauti za kimetaboliki kati ya spishi (Berthou F. et al. Xenobiotica II (678-127) inaonyesha kwamba dawa inaweza kuwa na uwezo wa kupanua kwa njia tofauti kulingana na aina ya binadamu au mnyama. Kwa hiyo nadhani kuna uwezekano mbili: - Kampuni hizi ni optimizing dawa kwa ajili ya wanadamu na kama kwa bahati nzuri inaonyesha shughuli katika wanyama wao kuchukua faida ya fursa. - Wao ni optimizing ni katika spishi za wanyama na mapato itasaidia fedha maendeleo kwa ajili ya wanadamu, kuanzia kuongoza optimization. Katika kesi zote mbili, lengo ni kupata faida ya haraka juu ya uwekezaji na aina ya uthibitisho wa dhana in vivo kuvutia wawekezaji au makampuni ya dawa. "Hii inaweza kuwa na thamani ya kufikiri juu, lakini, kama kawaida, makampuni haja ya watu sahihi, kama vile wataalamu wa kimetaboliki au veterinarians, kama hawataki kupoteza fedha zaidi kuliko wanatarajia kufanya. """