Hansa Medical AB (publ) - Interim report January 1 - June 30 2013
The period in brief
- Ongoing clinical phase I study with drug candidate IdeS
- A new treatment concept under development with EndoS has been made public through publication in PNAS
- Net sales for the Group amounted to SEK 0.6 (1,3) M
- The Group’s net loss amounted to SEK -8.6 (-9.7) M
- Operating income for the Group amounted to -8.6 (-9.7) M
- Earnings per share amounted to SEK -0.39 (-0.48)
During thousands of years, the bacteria S.pyogenes, has developed two exciting enzymes: IdeS and EndoS. The bacteria uses these enzymes to modulate the human immune system so that the bacteria can survive in the human body. Hansa Medical turns foe to friend and uses both of these enzymes to develop pharmaceuticals for specific types of immune modulation treatment, with regards to anti-bodies. IdeS inactivates antibodies through enzymatic cleavage and EndoS changes the antibodies’ characteristics through modification of their sugar structure.
The immediate purpose of the drug candidate, IdeS is to ensure that a certain group of dialysis patients can undergo kidney transplantation. Today, it is almost impossible for certain types of patients to become transplanted as their antibodies immediately would reject the kidney being transplanted. Our vision is that treatment with IdeS approximately one hour prior to transplantation, removes this obstacle and makes transplantation possible also for these patients.
In March 2013, Hansa Medical initiated a clinical phase I study with IdeS. We have worked hard and long with making this possible and we are, of course, both proud and pleased to have made this degree of progress with IdeS. The trial is undertaken in Sweden with a total of 36 healthy volunteers and our goal is to report the results from this study later in 2013, or in the beginning of 2014. The main goal is to find a safe and effective dose level to facilitate a phase II study with transplantation patients in 2014.
The enzyme EndoS changes antibodies so that they become more anti-inflammatory. In scientific terms, this is very exciting and the Associate Professor Nandakumar et.al., describes this in detail in the article ”Dominant suppression of inflammation by glycan-hydrolyzed IgG”. This article was published in the May issue of the Proceedings of the National Academy of Sciences of the United States (PNAS), www.pnas.org.
Hansa Medical sees a very interesting commercial potential: in the strengthening of IVIG products’ antiinflammatory characteristics. IVIG (Intravenous immunoglobulin) is a pharmaceutical where the active substance is comprised of human antibodies (IgG) which have been extracted from blood plasma from a large number of donators. IVIG is used for intravenous therapy for immune deficiency diseases and as antiinflammatory treatment in a number of different autoimmune diseases, as well as prevention and treatment of transplant rejection. The market for IVIG products in 2009 amounted to USD 5.6 billion. Today’s IVIG doses for antiinflammatory treatment are very high (up to two grams per kilogram body weight). We are now working with verifying and strengthening the preclinical findings towards a very exciting commercial vision: Through modification with EndoS, the creation of IVIG products with increased effect and reduced doses.
In June 2009, we licensed the right to HBP analysis for the diagnosis of severe sepsis to Axis-Shield Diagnostics. The market for the diagnosis of severe sepsis is estimated at SEK one billion and in December 2012 Axis-Shield launched a method for HBP analysis which now makes it possible for clinical researchers and diagnostic companies to, themselves, test the method and, consequently, see the daily clinical benefit provided by it: the early diagnosis of severe sepsis and faster initiation of antibiotic treatment and intravenous therapy than is possible in current clinical practice.
Axis-Shield now markets HBP analysis towards emergency doctors and diagnostic companies. During 2011 and 2012 a major multicentre study was performed including more than 800 patients. The results from this clinical study comprise an important stage in marketing, and publication of the results is expected during 2013, in a clinically-oriented scientific journal.
Emanuel Björne, CEO, Hansa Medical AB (publ)