Are there any expectations that the new small molecule treatments for HCV will entirely replace interferon in the future? I'm just curious because that would obviously negatively impact HGSI and ZGEN, among others, long-term.
Going through Clinical Trials.gov noticed the follow Phase 2 programs think all are on the list for those wanting more info the links and a couple things I noticed are below.
http://clinicaltrials.gov/ct2/show/NCT00797745 - Pharmacokinetics/Pharmacodynamics Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 . They have 6 arms + SOC. Using ritonavir, Some 4 week lead in, once and twice daily . 140 patients
http://clinicaltrials.gov/ct2/show/NCT00561353 - OPERA 1: A Study of the Hepatitis C Virus (HCV) Protease Inhibitor TMC435350 . (25 mg daily or 75 mg daily or 200 mg daily or 400 mg daily) . 130 patients
[Added entry for Alios BioPharma and additional detail (c/o ghmm) on SCH 900518, TMC435, and BI201335; IDX184, now in phase-1/2, moved up one notch.]
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; 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; and clemizole (Stanford University; preclinical), an NS4B inhibitor: #msg-31857987.
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