| |
Trek Therapeutics buys rights to Medivir's hep C candidate MIV-802
|
| |
| |
http://www.thepharmaletter.com/article/trek-therapeutics-buys-rights-to-medivir-s-hep-c-candidate-miv-802
http://trektx.com/
Swedish drugmaker Medivir (OMX: MVIR) has licensed exclusive rights to its hepatitis C virus (HCV) treatment MIV-802 to USA-based Trek Therapeutics, a private, clinical-stage public benefit corporation developing treatments for serious infections.
The deal will see Trek Therapeutics gain the rights to develop and commercialize the nucleotide polymerase inhibitor globally, excluding in China, Taiwan, Hong Kong and Macau.
Medivir is entitled to receive milestones based on successful clinical development and royalties capped at a mid-teens percentage upon commercialization of MIV-802 containing products.
BioPhausia, a subsidiary of Medivir, is granted options to commercialize MIV-802 containing products in the Nordics and certain Western European countries. Other terms of the transaction were not disclosed.
Niklas Prager, chief executive of Medivir, said: "We are pleased to have Trek Therapeutics as a partner with their deep knowledge of HCV drug development, and their mission to make competitive treatments accessible to world populations."
The Boston-based company is developing combination treatments for HCV using its portfolio of antiviral agents including faldaprevir, a protease inhibitor, TD-6450, a NS5A inhibitor, and lomibuvir, a non-nucleoside NS5B inhibitor.
Its chief executive is Ann Kwong, who said after the Medivir announcement: "Nucleotides are essential components of combination regimens to provide a short duration of treatment with low levels of resistance. We are excited to develop MIV-802 as part of a highly-effective combination treatment to address HCV."
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=371560
----------------------
http://www.prnewswire.com/news-releases/trek-therapeutics-initiates-phase-2a-study-of-faldaprevir-and-td-6450-with-and-without-ribavirin-in-patients-with-hcv-gt-1b-300287780.html
---------------------------------------
TREKtx intends to develop a competitive curative drug combination for HCV and make it available at a profitable but accessible price. TREKtx also plans to develop an affordable point-of-care HCV RNA diagnostic that can be used in both the developed and developing world. In the future, TREKtx also plans to license and develop additional compounds to treat or cure other infectious diseases.
In October 2015, TREKtx began a Phase 2a randomized, double-blind trial to investigate the safety and efficacy of 120 mg faldaprevir QD in combination with 60 mg or 120 mg TD-6450 (NS5A inhibitor) QD plus ribavirin BID for 12 weeks in treatment-naïve, noncirrhotic patients chronically infected with genotype 4 HCV. Following this study, a combination will be investigated in a Phase 2a study in genotype 1 patients.
TREKtx has begun to develop two HCV combination therapies for different patient populations. Our goal is to achieve a good safety and efficacy profile (SVR of ≥ 95%) and treatment duration of 12 weeks or less. We have obtained worldwide exclusive rights to faldaprevir and TD-6450.
⋅ Faldaprevir (FDV, HCV protease inhibitor) is a protease inhibitor that TREKtx has acquired from Boehringer Ingelheim. FDV has completed Phase 3 studies in combination with Peg IFN and ribavirin (RBV). In a Phase 2 study in HCV genotype 1a patients, treatment with FDV in combination with PPI-668, a 5A inhibitor, and deleobuvir, a non-nucleoside inhibitor plus RBV for 12 weeks resulted in 92% SVR.
⋅ TD-6450 (NS5A inhibitor) was acquired from Theravance Biopharma andachieved best-in-class dose-dependent antiviral activity in genotype 1 in a Phase 1b study with median maximal declines of HCV RNA of 3.87, 4.63 and 4.89 log10 IU/mL for once daily doses of 60, 120 and 240 mg for 3 days, respectively.
http://trektx.com/portfolio/
----------------------------------
MIV-802 to Trek Therapeutics
HUDDINGE, Sweden --(BUSINESS WIRE)
Regulatory News:
Medivir AB (Nasdaq Stockholm: MVIR) and Trek Therapeutics (TREKtx) today announced that TREKtx has licensed the exclusive rights to develop and commercialize MIV-802 globally, excluding China, Taiwan, Hong Kong and Macau. MIV-802 is a nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV) infection.
Under the terms of the agreement, Medivir is entitled to receive milestones based on successful clinical development and royalties capped at a mid-teens percentage upon commercialization of MIV-802 containing products. BioPhausia, a subsidiary of Medivir, is granted options to commercialize MIV-802 containing products in the Nordics and certain Western European countries. Other terms of the transaction were not disclosed.
"We are pleased to have Trek Therapeutics as a partner with their deep knowledge of HCV drug development, and their mission to make competitive treatments accessible to world populations" said Niklas Prager, CEO of Medivir.
TREKtx is developing combination treatments for HCV utilizing its portfolio of antiviral agents including faldaprevir, a protease inhibitor, TD-6450, a NS5A inhibitor, and lomibuvir, a non-nucleoside NS5B inhibitor.
"Nucleotides are essential components of combination regimens to provide a short duration of treatment with low levels of resistance." said Ann Kwong, Ph.D., CEO of TREKtx. "We are excited to develop MIV-802 as part of a highly-effective combination treatment to address HCV."
Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08.45 CET on 17 August 2016.
About MIV-802
MIV-802 is a potent, pangenotypic nucleotide inhibitor of the HCV NS5B polymerase. Hepatitis C treatments comprise combinations of pharmaceuticals with different antiviral mechanisms. Preclinical data indicate that MIV-802 can be used effectively in combination with other classes of antiviral agents for the treatment of HCV, including protease inhibitors, non-nucleoside NS5B inhibitors, and NS5A inhibitors.
About Medivir
Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. BioPhausia is a wholly-owned subsidiary of Medivir, with a portfolio of prescription pharmaceuticals made available for the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.
About Trek Therapeutics
Trek Therapeutics, PBC is a private, clinical stage public benefit corporation developing treatments for serious infections. Its mission is to profitably develop affordable and accessible medicines to treat infectious diseases and to commercialize them for global populations. TREKtx is currently conducting phase II clinical trials in patients with chronic HCV infection using a combination of direct acting antivirals, and is also evaluating treatments for other infectious diseases. For further information, please visit www.trektx.com.
Medivir AB
Ola Burmark, CFO
mobile: +46 (0) 725 480580
or
Trek Therapeutics
Jane A. Kramer
e-mail: jane.kramer@trektx.com
Phone: +1-781-799-9524
----------------------------------------
Trek Therapeutics Initiates Phase 2a Study of Faldaprevir and TD-6450, With and Without Ribavirin, in Patients with HCV GT 1b.
CAMBRIDGE, Mass., June 21, 2016 /PRNewswire/ -- Trek Therapeutics (TREKtx), a private, clinical stage public benefit corporation developing affordable and accessible treatment regimens for chronic hepatitis C virus (HCV) infections has initiated a Phase 2a study evaluating TD-6450 plus faldaprevir (FDV) with and without ribavirin (RBV) in patients with genotype 1b (GT 1b) HCV infection in New Zealand and the United States. The GT 1b study was initiated following TREKtx analysis of interim results from a Phase 2a study evaluating FDV plus TD-6450 and RBV in patients with HCV GT 4. In that 16-patient study, all patients achieved HCV RNA <15 IU/mL by treatment Week 3, and all patients with post-treatment data (10/16) have achieved a sustained viral response 4 weeks after the end of treatment (SRV4). Of the 5 patients who have completed post-treatment follow-up, all have SVR12. Six patients still on treatment have maintained HCV RNA <15 IU/mL.Final results for the GT 4 study will be analyzed later this year.
About TD-6450
TD-6450, a multivalent NS5A inhibitor licensed from Theravance Biopharma, Inc., was designed to have improved antiviral activity against genotype 1 resistance-associated variants (RAV) resistant to first generation NS5A inhibitors. TD-6450 has successfully completed Phase 1 studies in both healthy volunteers and HCV patients.
About Faldaprevir
FDV is a well-characterized HCV protease inhibitor licensed from Boehringer Ingelheim.
Phase 3 studies evaluating FDV in combination with pegylated interferon and RBV have been completed.
About HCV
Hepatitis C is an infectious disease of the liver. Worldwide, 130-150 million people have chronic HCV infection and most are undiagnosed. Three quarters of people with chronic HCV infection will develop chronic liver disease. Development of affordable therapies for HCV is a global health priority. In the United States, chronic HCV infection is the leading cause of cirrhosis and liver cancer, and the most common reason for liver transplantation. Multiple highly effective, safe, and well-tolerated regimens have been developed for chronic HCV. The creation of these drugs sets the stage for a Campaign to Eradicate HCV.
The accessibility of HCV treatment is limited by the low diagnosis rate and the high cost of drugs.
About Trek Therapeutics
Trek Therapeutics, PBC is a private, clinical stage public benefit corporation developing treatments for serious infections. Its mission is to profitably develop affordable and accessible medicines to treat infectious diseases and to commercialize them for global populations.
Contact: Jane A. Kramer
jane.kramer@trextx.com 781-799-9524
SOURCE Trek Therapeutics
Related Links
http://trektx.com
|
|
| |
| |
|
|
|
