Hello Dew, and thanx for your updating list on HCV candidates in clinical trials...
Question: Which drugs currently in clinical trials ((Most likely to fail, and why)) from the other side of the coin, as an informational tool to the biotech investor whom is interested in investing in HCV/HIV therapies....TIA
[Updated Telaprevir, Boceprevir, TMC435, IFN-lambda, and R7128 entries for presentations at AASLD; new entries for GlobeImmune immunomodulator and NS5A inhibitors from various companies.]
The following paragraphs are in descending order of likelihood of success. (Paragraphs 6 and 7 are “catchall” groupings that do not explicitly 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). 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-31442799, #msg-33282976, #msg-33283156. 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-26228377; 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 a.k.a. R7227 (ITMN/Roche; phase 1b), a protease inhibitor that may be even better than Telaprevir and Boceprevir but is still early in development: #msg-28126092.
3. Locteron (Biolex; phase-2), a long-acting interferon made in transgenic plants that is all but indistinguishable from the SoC peg-ifn products marketed by Roche and SGP: #msg-28786162. (Biolex recently bought out its partner, OctoPlus, and raised $60M to fund the Locteron program: #msg-32662307, #msg-32662762.)
4. Various oral agents in phase-1 or phase-2 that use an established MoA. These include TMC435 (Medivir/JNJ; phase-2), a protease inhibitor: #msg-33283588; R7128 (VRUS/Roche; phase-1b), a nucleoside polymerase inhibitor: #msg-33300630 (kidney tox in monkeys), #msg-32238916, #msg-32651030; GS-9190 (GILD; phase-2 starting by year-end), a non-nucleoside polymerase inhibitor: #msg-32919311; and ANA598 (ACHN, phase-1b), a non-nucleoside polymerase inhibitor: #msg-33172848. Roche has started a trial of ITMN-191 plus R7128 without either interferon or ribavirin:#msg-33446127.
5. The “other” interferons: Albuferon (HGSI/NVS; phase-3): #msg-26199740; IFN-alpha-XL (FLML; phase-1): #msg-28837983; and IFN-Lambda (ZGEN; phase-1b): #msg-33311734.
6. Miscellaneous very-early-stage compounds that use an established MoA — e.g. IDX184 (IDIX; phase-1), a nucleotide polymerase inhibitor: #msg-31043481, #msg-26915921; and ACH-1625 (ACHN; preclinical), a protease inhibitor: #msg-31459921.
7. Miscellaneous early- and very-early-stage compounds that use a novel MoA — e.g. NS5A inhibitors from various companies: #msg-33270620, #msg-33270670; 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; Sirna-034 (MRK; status unknown), a dual siRNA: #msg-12665661; ACH-1095 (ACHN/GILD; preclinical), an NS4A inhibitor: #msg-31459921; and clemizole (Stanford University; preclinical), an NS4B inhibitor: #msg-31857987.
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