Dr. Deepti Jaggi, Co-founder, President and Chief Medical Officer of clinical stage biopharmaceutical company, Vivonyx, talked about their innovative lifesaving antibiotic therapies that can target resistant strains and prevent bacterial resistance at http://www.bio2devicegroup.org . Dr. Jaggi has spent 20 years in the Healthcare & Lifesciences industry and is a co-founder of multiple biotechnology companies including Novakos, a Lifesciences accelerator and Neurokos Inc., a clinical stage neurology company. Vivonyx has a product portfolio based on over 25 years of research, significant in-vitro & in-vivo data and multiple proof of principle clinical studies.
Dr. Jaggi began her talk with discussion on the enormity of the problem of antibiotic resistance and by giving the history of antibiotic therapies and resistance mechanism. Infections resulting from resistant microorganisms do not respond to conventional treatment and frequently result in death. Sometimes patients admitted for common elective surgery enter the hospital and catche an infection in the hospital and do not leave the hospital, alive. Further, people get ventilator associated pneumonia, catheter induced bloodstream infections, surgical site infections, in addition to health care related infections, with mounting healthcare costs. For instance, each ventilator associated pneumonia costs upwards of $50K. All infections are treated with antibiotics and many people are developing resistance frequently to first line of treatment. The problem is extremely serious in developing countries. For instance, out of the million Chinese who develop TB every year, it is believed that, 110,000 get a form that is resistant to the mainstay drugs. Patients with such multidrug-resistant or MDR tuberculosis have to be treated for up to two years with expensive second-line drugs that are toxic and less effective. Worse yet, there are recent indications that close to 10,000 Chinese are coming down with extensively resistant or XDR-TB, meaning that it is also resistant to at least two of the second-line drugs — and thus may be incurable in many cases. Due to many reasons including, inadequate national commitment to a comprehensive and coordinated response until recently, ill-defined accountability and insufficient engagement of communities and healthcare providers and pharmacies, weak or absent surveillance and monitoring systems, uncertain supply of medicines, inappropriate and irrational use of medicines, lack of education, and often poor infection prevention in the first place, lead to the problem of antibiotic resistance in enormous proportions.
So what is AMR or antimicrobial resistance? Antibiotic resistance is a type of drug resistance where a microorganism is able to survive exposure to an antibiotic. Dr. Jaggi asked “what would you do if someone tries to hit you? You would try to duck. And if you survive, and they try again then you get better at pre-empting and ducking every time there is a slightest threat”. While a spontaneous or induced genetic mutation in bacteria may confer resistance to antimicrobial drugs, bacteria are even more efficient. Genes that confer resistance can be transferred between bacteria in a horizontal fashion by conjugation, transduction, or transformation. Thus, a gene for antibiotic resistance that evolves via natural selection may be shared. Evolutionary stress such as exposure to antibiotics then selects for the antibiotic resistant trait. Active efflux is the mechanism that contributes to bacterial antibiotic resistance. Some efflux systems are drug-specific, whereas others may accommodate multiple drugs, and thus contribute to bacterial multidurg resistance or MDR. Efflux pumps are transport proteins involved in the extrusion of toxic substrates (including virtually all classes of clinically relevant antibiotics) from within cells into the external environment.
A great deal of Vivonyx work is still under wraps. But Dr. Jaggi shared broad information about the company’s focus and then made a business case for the same. Vivonyx technology is focused on suppressing antibiotic resistance, and developing antibiotics with significantly improved efficacy, expanded antibiotic spectrum and restored activity in resistant strains. Vivonyx technology works with a broad variety of already well-established and widely used antibiotics. Vivonyx is working on therapies that prevent drug resistance environment, can drop mutation prevention concentration, shorten duration of therapy, and prevent resistance in bacteria because they do not mutate. Making a strong business case, Dr. Jaggi began by saying, antibiotics is a huge problem, with growing market, and tremendous success rate with over 28.1%. This is a classic short term drug, with excellent in-vitro correlation which makes an excellent case for clinical development. The test done with the patient’s culture is the same test done in the Petri dish. There is a highly attractive exit potential, as is evident in case of all previous antibiotics. Often a deterrent to antibiotic innovation is that a new drug is kept as a second or third line of treatment for resistant cases. In this case however, it can be used as primary line of treatment since it does not lead to resistance. Finally, the GAIN act that recently passed in the house and the senate and is about to become a law, with an aim to provide incentives to increase the commercial value of innovative antibiotic drugs and streamline the regulatory process is fast tracking FDA review process. And the bill is extending the exclusivity period for new qualified infections disease products by five (5) years. The talk was followed with Q&A and discussion on issues including whether or not one should extensively use over the counter antimicrobial products and other questions that the audience had for Dr. Jaggi. For further information, please refer to http://www.vivonyx.com .