Dew, has IDIX added any color to the differences between IDX136 and IDX316, the protease inhibitors? I know they only plan to advance one into trials.
Also, has IDIX commented on any specific potential advantages that either compound may have compared to Telaprevir, Boceprevir, or any of the other PIs under development?
ABBOTT PARK, Ill., and WATERTOWN, Mass., Feb. 18 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) and Enanta Pharmaceuticals announced today the advancement of their Hepatitis C (HCV) collaboration with a first-in-human study evaluating ABT-450, an oral protease inhibitor for the treatment of chronic HCV. The objectives of the trial include assessment of safety, tolerability and pharmacokinetics. ABT-450 was discovered as part of a worldwide alliance between Abbott and Enanta to discover, develop and commercialize protease inhibitors for the treatment of HCV.
"Hepatitis C is a serious global health concern, with 170 million people currently infected by six different HCV genotypes," said John M. Leonard, M.D., senior vice president, Global Pharmaceutical Research and Development, Abbott. "As a global leader in the development of antiviral therapies and diagnostics, Abbott is bringing its decades of antiviral experience, particularly with protease inhibitors, to this collaboration and to the fight against HCV."
"ABT-450 demonstrated favorable potency in vitro across various HCV genotypes and highly resistant strains," said Jay R. Luly, Ph.D., president and CEO of Enanta Pharmaceuticals. "We look forward to working with Abbott to advance ABT-450, and to our building a pipeline of HCV protease inhibitors that addresses this widespread disease."
Phase 1 Study Design
The Phase 1, double-blind, placebo-controlled study for ABT-450 announced today is a single, ascending oral dose trial in healthy volunteers.
About Enanta
Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best-in- class small molecule drugs in the anti-infective field. Enanta is developing novel protease, polymerase and cyclophilin-based inhibitors targeted against the Hepatitis C virus (HCV). Additionally, the company has created a new class of macrolide antibiotics, called Bicyclolides, which overcomes bacterial resistance. Antibacterial focus areas include superbugs, respiratory tract infections and intravenous and oral treatments for hospital and community MRSA. Enanta is a privately held company headquartered in Watertown, Mass. Enanta's news releases and other information are available on the company's web site at http://www.enanta.com.
About Abbott
Abbott is working to advance the treatment of Hepatitis C (HCV) through a multifaceted discovery and development program that leverages the company's deep experience in antiviral medicines. Compounds in various states of development include protease inhibitors (ABT-450) and polymerase inhibitors (ABT-333 and ABT-072). In addition to developing HCV therapies, Abbott also offers laboratory tests for patient diagnosis, blood screening tests for hospitals and blood banks, and molecular diagnostic tests to measure HCV viral load and resistance. Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 69,000 people and markets its products in more than 130 countries.‹
[Added entries for ABT’s ABT-450 and Romark’s nitazoxanide.]
The following paragraphs are in descending order of likelihood of success. (There is no claim of completeness here; i.e. paragraphs 3-6 do not necessarily mention all of the applicable drug candidates within the grouping.)
1. The two leading protease inhibitors: Telaprevir (VRTX/JNJ; phase-3) and Boceprevir (SGP; phase-3). The Telaprevir program is further advanced, so let’s call Telaprevir and Boceprevir 1a and 1b, respectively.
These two drugs have shown comparable efficacy in 24-28 week regimens of phase-2 trials in the genotype-1, treatment-naïve setting: #msg-31190433, #msg-33793333, #msg-33282976. Background posts: VRTX PROVE-1/2 trials made simple: #msg-29019931; PROVE-1/2 detailed results: #msg-28746843; overview of Telaprevir phase-3 program: #msg-27623529 (ADVANCE study), #msg-26228377 (outline of both studies); Boceprevir starts phase-3: #msg-29474929.
Telaprevir and Boceprevir are also being tested in the second-line setting, Telaprevir in 24- and 48-week regimens and Boceprevir in 36- and 48-week regimens. Background posts: Telaprevir phase-3 REALIZE study: #msg-32901932; Telaprevir phase-2b PROVE-3 study: #msg-29896176; Telaprevir ‘107’ open-label phase-2 extension for PROVE-1/2 failures: #msg-33282976; Boceprevir phase-3 RESPOND-2 study: #msg-29474929.
2. ITMN-191 and R7128, the two oral drugs that Roche is testing is the INFORM-1 study that does not include interferon or ribavirin: #msg-33967428, #msg-33446127, #msg-33497987. ITMN-191 a.k.a. R7227 (ITMN/Roche; phase 1b) is a protease inhibitor: #msg-34747018. R7128 (VRUS/Roche; entering phase-2b) is a nucleoside polymerase inhibitor: #msg-34746768, #msg-32238916, #msg-32651030.
Although ITMN-191 and R7128 are not necessarily the best drugs in their respective classes, the fact that Roche is testing them in INFORM-1 gives them a leg up on competing drugs at the same stage of development, IMO.
3. Agents in phase-2b or phase-3 that use an established MoA: Albuferon (HGSI/NVS; phase-3), an albumin-conjugated interferon : #msg-34043876, #msg-34071611, #msg-13781766, #msg-20275478, #msg-34770426 (new trial with monthly dosing); BI201335 (B-I; phase-2b), a protease inhibitor: #msg-33564560, #msg-34774813; and Locteron (Biolex; phase-2), a long-acting interferon made in transgenic plants that may qualify for the 505b2 approval pathway: #msg-28786162. (Biolex recently bought out its partner, OctoPlus, and raised $60M to fund the Locteron program: #msg-32662307, #msg-32662762.)
4. Agents in phase-1 or phase-2a that use an established MoA. These include TMC435 (Medivir/JNJ; phase-2), a protease inhibitor: #msg-33283588, #msg-34774813; MK-7009 (MRK, phase-2a), a protease inhibitor: #msg-34337398, #msg-34335327; SCH 900518 (SGP, phase-2a), a protease inhibitor (SGP’s follow-up to Boceprevir): #msg-34338549, #msg-34774813; GS-9190 (GILD; phase-2), a non-nucleoside polymerase inhibitor: #msg-32919311; IDX184 (IDIX; phase-1/2), a nucleotide polymerase-inhibitor: #msg-34763865, #msg-26915921ANA598 (ANDS, phase-1b), a non-nucleoside polymerase inhibitor: #msg-34678306; IFN-alpha-XL (FLML; phase-1b): #msg-28837983; ABT-450 (ABT/Enanta, phase-1), a protease inhibitor: #msg-35708745; and IFN-Lambda (BMY/ZGEN; phase-1b): #msg-34768182 (BMY partnership), #msg-33311734 (interim phase-1b data).
5. Very-early-stage compounds that use an established MoA. These include ACH-1625 (ACHN; preclinical), a protease inhibitor: #msg-31459921; IDX375 (IDIX, preclinical), a non-nucleoside polymerase inhibitor: #msg-34334563, #msg-31043481; ‘hyperglycosylated’ interferon (Alios BioPharma, preclinical): #msg-35612425; IDX136/IDX316 (IDIX, preclinical), two related macrocyclic protease inhibitors of which IDIX will select one to advance into phase-1: #msg-31043481.
6. Early- and very-early-stage compounds that use a novel MoA. These include BMS-790052 (BMY, phase-1), an NS5A inhibitor: #msg-33270670; A-831 (AZN, status unknown), an NS5A inhibitor: #msg-16682361; a preclinical NS5A program that GSK acquired from GNLB: #msg-33209281, #msg-33211420; ANA773 (ANDS, phase-1), an oral TLR7 modulator: #msg-33244419; IL-7 (Cytheris, phase-1/2) an injectable immunomodulator: #msg-33152073; GI-5005 (GlobeImmune, phase-2), an injectable immunomodulator: #msg-33322543; ACH-1095 (ACHN/GILD; preclinical), an NS4A inhibitor: #msg-31459921; an unnamed NS5A inhibitor from Presidio Pharma (status unknown): #msg-27791536; clemizole (Stanford University; preclinical), an NS4B inhibitor: #msg-31857987; and nitazoxanide (Romark/Chugai, phase-2): #msg-35738696.
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