Biotech Values

[DewDiligence]

HCV: Most Likely to Succeed (IMHO)

[New entry for BI201335 (thanks, genisi) and
tidbits on the INFORM-1 all-oral cocktail from
ITMN webcast.]


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; BI201335 (B-I; phase-2), a protease inhibitor: #msg-33564560; 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, #msg-33497987.

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.

JMHO, FWIW