PASADENA, CA, USA & HOPKINTON, MA, USA I October 6, 2016 I Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) and Spring Bank Pharmaceuticals, Inc. (NASDAQ: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, cancer, and inflammatory diseases, today announced an agreement to perform collaborative studies on Arrowhead’s ARC-520 and Spring Bank’s SB 9200, for the treatment of chronic Hepatitis B (HBV). The companies plan to first conduct preclinical models with both agents together and then study the agents clinically in a cohort to be added to Arrowhead’s ongoing MONARCH Phase 2b study, in which patients will receive a dosing regimen that includes ARC-520, SB 9200, and an oral direct-acting antiviral.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161006005402/en/
“The MONARCH Phase 2b combination study was specifically designed to be iterative in nature, allowing us to seamlessly add cohorts when additional novel agents are available to study in combination with ARC-520,” said Bruce Given, M.D., chief operating officer and head of R&D at Arrowhead. “We see ARC-520, which is designed to silence the production of all HBV gene products, as a potential backbone therapy for combinations. Spring Bank’s SB 9200 is a promising immunomodulatory agent with an interesting mechanism that we think has significant therapeutic potential in combination with ARC-520 and a NUC.”
“Our collaboration with our colleagues at Arrowhead Pharmaceuticals will be the first study of two completely novel agents in HBV, both focused on delivering a functional cure,” said Nezam Afdhal, M.D., chief medical officer at Spring Bank Pharmaceuticals. “We believe combining SB 9200 with Arrowhead’s ARC-520, along with an approved nucleotide(side) polymerase inhibitor, has the potential to lead to a functional cure. Together, we hope to demonstrate in the MONARCH trial that triple therapy can increase HBV functional cure rates with a more favorable tolerability profile and perhaps a shorter duration of treatment relative to current standard of care with interferon-based regimens.”
About SB 9200
SB 9200 is Spring Bank’s novel small molecule, orally-available selective immunomodulator compound being developed as both monotherapy and combination therapy as a backbone for the treatment of chronic HBV and other viral diseases. SB 9200 is currently being studied in the ACHIEVE Phase II global trial. Part A of the ACHIEVE study is a placebo-controlled, sequential cohort, double blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by tenofovir disoproxil fumarate 300mg (Viread Gilead Sciences Inc.) for a further 12 weeks. Part B of the ACHIEVE study will evaluate SB 9200 in combination with tenofovir and as monotherapy versus tenofovir monotherapy after the optimal doses of SB 9200 are determined in Part A.
About ARC-520
Arrowhead’s ARC-520 is being investigated for its potential to produce functional cures in patients with chronic hepatitis B virus (HBV) infection. ARC-520 intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogs act, and is designed to silence the production of all HBV gene products. The small interfering RNAs (siRNAs) in ARC-520 engage the body’s normal cellular RNAi machinery and direct specific cleavage of HBV RNA transcripts, thereby reducing the levels of HBV proteins and the RNA template used to produce viral DNA. Arrowhead is investigating ARC-520 specifically to determine if significantly reducing circulating and non-circulating viral proteins and RNA will allow for re-constitution of an effective host immune response and ultimately HBsAg seroclearance resulting in functional cure. As many as 350-400 million people worldwide are chronically infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally. Arrowhead is currently conducting Phase 2b multiple dose and combination studies in chronic HBV patients. In clinical studies to date, the most common reported adverse events in all subjects completing treatment were upper respiratory infection and headache.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. The company’s pipeline includes ARC-520 and ARC-521 for chronic hepatitis B virus infection, ARC-AAT for liver disease associated with alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and thromboembolic disorders, ARC-LPA for cardiovascular disease, and ARC-HIF2 for renal cell carcinoma.
For more information please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/alerts.cfm.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Pharmaceuticals, Inc.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleic acid hybrid, or SMNH, chemistry platform. The company is developing its most advanced SMNH product candidate, SB 9200, for the treatment of viral diseases, including hepatitis B virus.
SOURCE: Arrowhead Pharmaceuticals
Post Views: 208
PASADENA, CA, USA & HOPKINTON, MA, USA I October 6, 2016 I Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) and Spring Bank Pharmaceuticals, Inc. (NASDAQ: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, cancer, and inflammatory diseases, today announced an agreement to perform collaborative studies on Arrowhead’s ARC-520 and Spring Bank’s SB 9200, for the treatment of chronic Hepatitis B (HBV). The companies plan to first conduct preclinical models with both agents together and then study the agents clinically in a cohort to be added to Arrowhead’s ongoing MONARCH Phase 2b study, in which patients will receive a dosing regimen that includes ARC-520, SB 9200, and an oral direct-acting antiviral.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161006005402/en/
“The MONARCH Phase 2b combination study was specifically designed to be iterative in nature, allowing us to seamlessly add cohorts when additional novel agents are available to study in combination with ARC-520,” said Bruce Given, M.D., chief operating officer and head of R&D at Arrowhead. “We see ARC-520, which is designed to silence the production of all HBV gene products, as a potential backbone therapy for combinations. Spring Bank’s SB 9200 is a promising immunomodulatory agent with an interesting mechanism that we think has significant therapeutic potential in combination with ARC-520 and a NUC.”
“Our collaboration with our colleagues at Arrowhead Pharmaceuticals will be the first study of two completely novel agents in HBV, both focused on delivering a functional cure,” said Nezam Afdhal, M.D., chief medical officer at Spring Bank Pharmaceuticals. “We believe combining SB 9200 with Arrowhead’s ARC-520, along with an approved nucleotide(side) polymerase inhibitor, has the potential to lead to a functional cure. Together, we hope to demonstrate in the MONARCH trial that triple therapy can increase HBV functional cure rates with a more favorable tolerability profile and perhaps a shorter duration of treatment relative to current standard of care with interferon-based regimens.”
About SB 9200
SB 9200 is Spring Bank’s novel small molecule, orally-available selective immunomodulator compound being developed as both monotherapy and combination therapy as a backbone for the treatment of chronic HBV and other viral diseases. SB 9200 is currently being studied in the ACHIEVE Phase II global trial. Part A of the ACHIEVE study is a placebo-controlled, sequential cohort, double blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by tenofovir disoproxil fumarate 300mg (Viread Gilead Sciences Inc.) for a further 12 weeks. Part B of the ACHIEVE study will evaluate SB 9200 in combination with tenofovir and as monotherapy versus tenofovir monotherapy after the optimal doses of SB 9200 are determined in Part A.
About ARC-520
Arrowhead’s ARC-520 is being investigated for its potential to produce functional cures in patients with chronic hepatitis B virus (HBV) infection. ARC-520 intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogs act, and is designed to silence the production of all HBV gene products. The small interfering RNAs (siRNAs) in ARC-520 engage the body’s normal cellular RNAi machinery and direct specific cleavage of HBV RNA transcripts, thereby reducing the levels of HBV proteins and the RNA template used to produce viral DNA. Arrowhead is investigating ARC-520 specifically to determine if significantly reducing circulating and non-circulating viral proteins and RNA will allow for re-constitution of an effective host immune response and ultimately HBsAg seroclearance resulting in functional cure. As many as 350-400 million people worldwide are chronically infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally. Arrowhead is currently conducting Phase 2b multiple dose and combination studies in chronic HBV patients. In clinical studies to date, the most common reported adverse events in all subjects completing treatment were upper respiratory infection and headache.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. The company’s pipeline includes ARC-520 and ARC-521 for chronic hepatitis B virus infection, ARC-AAT for liver disease associated with alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and thromboembolic disorders, ARC-LPA for cardiovascular disease, and ARC-HIF2 for renal cell carcinoma.
For more information please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/alerts.cfm.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Pharmaceuticals, Inc.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleic acid hybrid, or SMNH, chemistry platform. The company is developing its most advanced SMNH product candidate, SB 9200, for the treatment of viral diseases, including hepatitis B virus.
SOURCE: Arrowhead Pharmaceuticals
Post Views: 208
