Santaris Pharma A/S
HOERSHOLM, Denmark & SAN DIEGO, November 5, 2011 - - New Phase 2a clinical data to be presented in late-breaking oral presentation at AASLD - - Miravirsen given as a four-week monotherapy treatment provided robust, dose-dependent antiviral activity with a mean reduction of 2 to 3 logs from baseline in Hepatitis C Virus (HCV) RNA (log10 IU/mL) that was maintained for more than four weeks beyond the end of therapy - Four out of nine patients treated at the highest dose with miravirsen became HCV RNA undetectable during the study, providing clinicalevidence thatmiravirsen'sunique mechanism-of-action offers high barrier to viral resistance and the potential for treatment cures with monotherapy - Miravirsen, the first microRNA-targeted drug to enter clinical trials, works by inhibiting miR-122, a microRNA required for HCV accumulation, was well tolerated in patients with chronic HCV infection - Miravirsen's long-lasting suppression of HCV RNA, high barrier to viral resistance, low propensity for drug interactions and favorable tolerability profile holdspromise as pivotal new treatment option given as monotherapy or in combination with direct acting antiviral agents as an interferon-free treatment to eradicate chronic HCV infection in multiple genotypes Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, presents new data from the Phase 2a trial showing that miravirsen given as a four-week monotherapy treatment provided robust dose-dependent anti-viral activity with a mean reduction of 2 to 3 logs from baseline in HCV RNA (log10 IU/mL) that was maintained for more than four weeks beyond the end of therapy.
HOERSHOLM, Denmark, and SAN DIEGO, October 3, 2011 - Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of microRNA and mRNA-targeted therapies, today announced the Company will report new clinical data results from the miravirsen Phase 2a proof-of-concept study to treat patients infected with the Hepatitis C virus (HCV) in a late-breaking oral presentation session at the American Association for the Study of Liver Diseases (AASLD) 2011 annual meeting.
HOERSHOLM, Denmark and SAN DIEGO, September 7, 2011 - Santaris Pharma A/S provides update on the development of miravirsen, a microRNA-targeted drug inhibiting miR-122, which is currently in Phase 2 clinical trials to treat patients infected with the Hepatitis C virus (HCV) Scientists at Santaris Pharma A/S demonstrate specificity of "tiny" 8-mer LNA-based compounds, which have shown to successfully inhibit entire microRNA families providing potential new approach for treating cancer, viral infections, cardiovascular and muscle diseases Data presented by scientists at Santaris Pharma A/S demonstrate successful "naked" delivery uptake of LNA-based compounds, a key advantage over other RNA-based technologies that require complex delivery vehicles Versatility of the LNA Drug Platform allows Santaris Pharma A/S to develop both microRNA and mRNA-targeted drugs with excellent specificity and increased affinity to drug target, providing improved potency and favorable tissue-penetrating properties Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, today announced advancements from the company's RNA-targeted research programs utilizing its proprietary Locked Nucleic Acid (LNA) Drug Platform.
HOERSHOLM, Denmark and SAN DIEGO, May 11, 2011 - Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, today announced that it has advanced a second drug from its cardiometabolic program, SPC4955 into Phase 1 clinical trials, for the treatment of high cholesterol.
HOERSHOLM, Denmark and SAN DIEGO, May 4, 2011 - -- Phase 1 clinical study to assess safety and tolerability of SPC5001, a RNA-targeted drug inhibiting PCSK9, which is a protein involved in removing low-density lipoprotein cholesterol (LDL-C) or "bad" cholesterol from the bloodstream -- In a study representing 147 million people, the World Health Organization recently reported that most patients with high cholesterol levels are not getting the treatment they need to reduce their risk of cardiovascular diseases such as heart attack and stroke -- Data from preclinical studies showed that SPC5001 provided fast-acting, potent and long-lasting inhibition of PCSK9 and reductions in LDL-C by up to 74% -- Developed using Santaris Pharma A/S Locked Nucleic Acid Drug Platform, SPC5001 is one of the drugs in the company's multi-faceted cardiometabolic program aimed at helping patients gain better control of their target cholesterol levels Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, today announced that it has advanced SPC5001 into Phase 1 clinical trials for the treatment of high cholesterol.
- Tiny Locked Nucleic Acid (LNA) based compounds, which are 8-mer LNA oligonucleotides, successfully inhibit entire microRNA families, providing potential new approach for treating a variety of diseases, including cancer, viral infections, cardiovascular and muscle diseases
- miR-33, an important microRNA that regulates high density lipoprotein (HDL) levels or "good" cholesterol, is a promising therapeutic target for raising good cholesterol levels
- Pfizer to make payment of $14 million for access to Santaris Pharma A/S Locked Nucleic Acid (LNA) Drug Platform to develop RNA-targeted drugs
- Santaris Pharma A/S initiates Phase 2a clinical trial with miravirsen (SPC3649) to assess safety and tolerability in treatment-naive patients with chronic Hepatitis C
- miRagen licenses rights to utilize Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform to identify and select drug candidates against miRagen's proprietary microRNA targets for the treatment of cardiovascular disease
- Santaris Pharma A/S Advances RNA-Targeted Drug Development Candidate Against PCSK9, an Important New Target for the Treatment of High Cholesterol
- SPC3649 Successfully Inhibits miR-122, a microRNA Important for Hepatitis C Viral Replication, Thereby Significantly Reducing Hepatitis C Virus in the Bloodstream in Chimpanzees Chronically Infected With the Hepatitis C Virus
- New Collaborations and Breakthrough Advancements in RNA-Based Drug Development Programs Lead Santaris Pharma A/S to Establish US Operations
- Santaris Pharma A/S Forms Strategic Alliance With Shire plc to Develop RNA-Based Medicines for the Treatment of Rare Genetic Disorders