Biotech Values

[DewDiligence]

HCV: Most Likely to Succeed (IMHO)

[GILD’s GS9190 does not cause unacceptable
QT-prolongation and will advance to phase-2.]


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. 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-16715663; Telaprevir ‘107’ extension study: #msg-28749322; 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 trials that use an established MoA. These include TMC435350 (Medivir/JNJ; phase-2), a protease inhibitor: #msg-28785830; R7128 (VRUS/Roche; phase-1b), a polymerase inhibitor: #msg-32238916, #msg-32651030; R1626 (Roche; phase-2), a polymerase inhibitor: #msg-28821034; and GS-9190 (GILD; phase-2 starting by year-end), a non-nucleoside polymerase inhibitor: #msg-32919311. (Note that Roche has two polymerase inhibitors in midstage development.)

5. The “other” interferons: Albuferon (HGSI/NVS; phase-3): #msg-26199740; IFN-alpha-XL (FLML; phase-1): #msg-28837983; and IFN-Lambda (ZGEN; phase-1): #msg-32606900.

6. Miscellaneous very-early-stage compounds that use an established MoA — e.g. IDX184 (IDIX; phase-1), a 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 novel MoA’s — e.g. ACH-1095 (ACHN/GILD; preclinical), an NS4A inhibitor: #msg-31459921; clemizole (Stanford University; preclinical): an NS4B inhibitor: #msg-31857987; and Sirna-034 (MRK; status unknown), a dual siRNA: #msg-12665661.

JMHO, FWIW