Hansa Medical develops second-generation IdeS molecules for repeat dosing
Hansa Medical AB announced today that the company is developing a new generation of molecules based on IdeS that will allow repeat dosing and thereby broadening the therapeutic opportunities into more chronic disease areas.
Since IdeS is a bacterial protein from Group A streptococcus the human immune system recognizes IdeS as foreign and reacts against the molecule. Hansa Medical’s phase I study demonstrated that anti-drug antibodies developed shortly after dosing. The antibodies reached peak levels two to four weeks after dosing and were normalized within 6-12 months. The new generation molecules have in addition to reduced antibody binding also reduced immunogenicity and increased specific activity. Hansa Medical has patent protected the new molecules.
”We now have a number of promising candidates that we will optimize during this year in order to select lead candidate and start pre-clinical development during next year.” says Christian Kjellman, Chief Scientific Officer of Hansa Medical AB.
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. IdeS degrades all IgG specifically, swiftly and efficiently. IdeS has been tested for safety and efficacy in numerous in vitro and in vivo models. During 2013 a Phase I clinical trial in 29 healthy subjects was conducted, demonstrating IdeS as efficacious and well tolerated with a favorable safety profile. During 2014 and 2015 a Phase II clinical trial in sensitized patients awaiting kidney transplantation has been conducted. Preliminary data shows that IdeS has very good efficacy in highly sensitized patients on the kidney transplant waitlist. The study shows that IdeS has the capacity to make sensitized patients eligible for transplantation by decreasing HLA antibodies to levels acceptable for transplantation. In addition to transplantation IdeS has potential indications within a variety of rare autoimmune diseases including anti-GBM disease. IdeS is protected by several patents and has been published in numerous peer review journals.
The information in this press release is disclosed pursuant to the Securities Markets Act or the Financial Instruments Trading Act. The information was released for public disclosure on February 12, 2015 at 11.00.
For further information, please contact:
Hansa Medical AB
Fredrik Lindgren, President and CEO
Mobile: 46 705 61 61 77
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation and rare autoimmune diseases. Other projects include HBP (a market introduced diagnostic marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's share (HMED) is listed on NASDAQ First North in Stockholm with Remium Nordic AB as Certified Adviser. Major shareholders are Farstorps Gård AB and Nexttobe AB.