|
- 现金
- 62111 元
- 精华
- 26
- 帖子
- 30437
- 注册时间
- 2009-10-5
- 最后登录
- 2022-12-28
|
Arbutus Provides a Corporate Update and Outlines 2016 Milestones
Globe Newswire
January 10, 2016: 04:00 PM ET
Phase II Multidose Study of ARB-1467 in HBV Patients Was Initiated in 2015
Phase II Single Dose HBsAg Reduction Data Expected in 3Q16
Four HBV Products in Clinical Development by Year-End
VANCOUVER, British Columbia and DOYLESTOWN, Pa., Jan. 10, 2016 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus (HBV) infection, today issued an update on recent company progress as well as a review of expected 2016 milestones.
“2015 was a very important year for Arbutus as we transitioned into a focused HBV therapeutic solutions company, with a broad pipeline of therapeutic agents which will ultimately be developed in combination regimens to cure HBV,” said Dr. Mark J. Murray, Arbutus' President and CEO. "In 2016, we look forward to delivering pipeline progress, including the recently initiated Phase II study of ARB-1467 (TKM-HBV, RNAi) in HBV-infected patients, for which we expect to report HBsAg reduction results from single dose in 3Q16 and from the multiple dose portion of the study in 4Q16.”
HBV Pipeline Update
ARB-1467 (TKM-HBV, RNAi) Phase II study. The Phase II study of ARB-1467 was initiated in December 2015. This trial will evaluate at least two doses of ARB-1467 (0.2 mg/kg and 0.4 mg/kg) in HBV infected patients. In the multiple ascending dose portion study, HBV infected patients who are on a stable background of nucleot(s)ide analog therapy will receive three monthly doses of ARB-1467. Eight subjects will be enrolled in each cohort with six subjects receiving ARB-1467, and two receiving placebo. ARB-1467, which comprises three RNAi triggers that target all four HBV transcripts, has been shown in preclinical studies to reduce all viral antigen levels as well as cccDNA. In 3Q16, Arbutus plans to release the HBsAg reduction results obtained with a single ARB-1467 dose from both the 0.2mg/kg and 0.4mg/kg dose cohorts followed by the full multi-dose data from both cohorts in 4Q16.
Phase I study of ARB-1467. The original Phase I single ascending dose (SAD) study has been completed, with healthy adult subjects having received a maximum dose of 0.4mg/kg. The study protocol was recently amended to enable testing of two higher doses of ARB-1467, which could also be evaluated in the Phase II multiple ascending dose (MAD) study in HBV infected patients. Final results of this Phase I study are expected in 1H16.
ARB-1740. Arbutus continues to work on developing follow-on RNAi products for HBV. This includes ARB-1740, a product candidate that is significantly more potent than ARB-1467 in preclinical studies and has the potential to be effective at lower clinical doses than the current sub-milligram dose range ARB-1467. ARB-1740 employs the same LNP formulation as ARB-1467 (with a different set of three RNAi triggers). Arbutus expects to file an IND (or equivalent) for ARB-1740 in 2H16.
Additional HBV products entering clinical development in 2016.
Arbutus will file an IND (or equivalent) in 2H16 for the lead compound from its small molecule cccDNA formation inhibitor program. In 2015, Arbutus presented preclinical data showing synergistic activity between cccDNA formation inhibitors and approved nucleot(s)ide analogs. Results of additional preclinical studies including combinations of agents with different mechanisms will be presented in 2016.
Arbutus will file an IND (or equivalent) in 2H16 for the lead compound from its small molecule capsid/core protein inhibitor program. Arbutus will be presenting results of preclinical studies including combinations of agents with different mechanisms at scientific meetings in 1H16.
In 2016, Arbutus will initiate clinical evaluation of ARB-1598 (formerly known as CYT-003), a TLR9 agonist, in immune biomarker induction. ARB-1598 is also being evaluated in preclinical studies including combinations of agents with different mechanisms, the results of which will be presented in 2016. Clinical combination studies with two or more proprietary pipeline candidates will be initiated in 2017.
Non-HBV Assets
Arbutus’ ongoing Phase II study of TKM-PLK1 in hepatocellular carcinoma is fully enrolled, with results expected in 1H16.
Alnylam’s LNP-enabled patisiran is currently in Phase III for the treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis). Alnylam has announced that it expects to submit a New Drug Application (NDA) for patisiran in 2017. Under the license agreement between the two companies, Alnylam will pay Arbutus a low-single digit royalty on future patisiran net sales.
In December 2015, Dicerna announced the start of a Phase I study in healthy volunteers for its LNP-enabled DCR-PH1 for the treatment of primary hyperoxaluria type 1 (PH1). Dicerna also announced that it expects to begin the first Phase I study of DCR-PH1 in patients with PH1 in early 2016. Under the license agreement between the two companies, Dicerna will pay Arbutus up to $22 million in development milestones plus a mid-single digit royalty on future DCR-PH1 sales.
Arbutus continues to explore opportunities to generate value from its LNP platform technology, which is well suited to deliver therapies based on RNAi, mRNA, gene editing, as well as other technologies.
Financial Update
Arbutus ended 3Q15 with $206 million in cash, which is expected to fund company operations into late 2018.
Upcoming Arbutus Pipeline Milestones
2016: Initiate clinical immune biomarker study for TLR9 agonist ARB-1598 in chronically infected HBV patients
2016: Preclinical data release on multiple pipeline programs, including results from preclinical combination studies of proprietary pipeline candidates
1H16: Phase II results for TKM-PLK1 in HCC
3Q16: Single dose HBsAg reduction data from the ARB-1467 (RNAi) Phase II trial in HBV-infected patients
4Q16: HBsAg reduction data from the multiple dose portion of the Phase II trial testing ARB-1467 in HBV-infected patients
2H16: File IND (or equivalent) for cccDNA formation inhibitor
2H16: File IND (or equivalent) for core protein/capsid assembly inhibitor
2H16: File IND (or equivalent) for ARB-1740 (RNAi)
2017: Initiate clinical combination studies with two or more proprietary product candidates
|
|
发表于 2016-1-12 14:05
