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Boehringer Ingelheim Halts Testing of Deleobuvir Hepatitis C Regimens

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Boehringer Ingelheim will cease development of regimens containing its non-nucleoside hepatitis C virus polymerase inhibitor deleobuvir (formerly BI 207127), the company announced this week.

Following an assessment of blinded data from the Phase 3 HCVerso 1 and 2 trials, which evaluated a regimen consisting of deleobuvir, the HCV protease inhibitor faldaprevir (formerly BI 201335), and ribavirin, Boehringer Ingelheim "has decided to halt further development" of deleobuvir-containing regimens, according to the announcement.

As reported at previous conferences and in the August 15, 2013, New England Journal of Medicine, this all-oral regimen initially appeared promising in the Phase 2b SOUND-C2 trial, though it was much effective against easier-to-treat HCV subtype 1b compared with 1a.

But in the Phase 3 trials, "[t]he combination showed a higher rate of premature discontinuations suggesting a lower efficacy rate compared to other interferon-free therapies in development," the announcement stated. "Boehringer Ingelheim has therefore concluded that the expected therapeutic value of the deleobuvir-containing regimen would not justify further development."

The Boehringer Ingelheim statement said that the company "will move forward with the submission process for faldaprevir," which has shown promising results in combination with pegylated interferon and ribavirin in the STARTVerso trials

But many patients and providers are waiting for all-oral hepatitis C treatment that avoids the side effects of interferon. Such regimens must clear an increasingly high bar given the excellent cure rates seen with all-oral regimens further ahead in the development process, such as Gilead Science's sofosbuvir (Sovaldi) plus ledipasvirsofosbuvir plus daclatasvir, and AbbVie's "3D" combination.

As reported at the recent AASLD Liver Meeting, a 3-drug regimen of deleobuvir and faldaprevir with Presidio Pharmaceuticals' NS5A inhibitor PPI-668 instead of ribavirin performed very well in Phase 2, curing most patients with hard-to-treat HCV 1a. However, the recent announcement did not mention this combination.

"Boehringer Ingelheim is committed to developing new treatments that provide high therapeutic value in areas of unresolved medical need," the statement concluded. "The company is focusing its efforts on numerous promising development projects in areas, such as immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology."

1/23/14

Source

Boehringer Ingelheim announcement. January 17, 2013.