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Replies to #69504 on Biotech Values
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ThomasS

12/05/08 1:05 AM

#69511 RE: DewDiligence #69504

I appreciate your update efforts on this particular topic.
However, I'm wondering if it will end up morphing into something more unwieldy, such as
"Most likely to succeed, efficacy"
"Most likely to succeed, tolerability"

An all-oral cocktail may well necessitate such. In other words, in the short term I suspect they will not be one and the same. In the longer term, they might be.
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ghmm

12/05/08 2:26 AM

#69513 RE: DewDiligence #69504

Does the "*****" surrounding indicate a study of distinction or just something newly added :)
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DewDiligence

12/09/08 6:01 PM

#69771 RE: DewDiligence #69504

HCV: Most Likely to Succeed (IMHO)

[Updated Albuferon entry for phase-3 results in geno-2/3.]


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). 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-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-33967428, #msg-33446127, #msg-33497987.*****

5. The “other” interferons: Albuferon (HGSI/NVS; phase-3): #msg-34043876, #msg-34071611, #msg-13781766, #msg-20275478; 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