Company |
Product |
Description |
Indication |
Status |
Date |
Abbvie Inc. (North Chicago) |
ABT-493 and ABT-530 |
NS3/4A protease inhibitor and NS5A inhibitor |
Genotype 1 hepatitis C virus |
Non-cirrhotic patients with chronic HCV treated showed high rates of sustained virologic response at 12 weeks post-treatment during two ongoing phase II studies, Surveyor-I and Surveyor-II; SVR12 rates achieved were 97% to 100% in genotype 1 infections, 96% to 100% in genotype 2 infections, and 83% to 94% in genotype-3 infections |
11/17/15 |
Bristol-Myers Squibb Co. (New York) |
Daklinza |
Daclatasvir |
GT3 HCV patients with compensated advanced fibrosis or cirrhosis |
Phase IIIb data of Daklinza and sofosbuvir showed that all patients achieved SVR12 in both the 12- and 16-week arms |
11/17/15 |
Enanta Pharmaceuticals Inc. (Watertown, Mass.) and Abbvie Inc. |
Viekira pak |
Ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets |
Genotype 1a or genotype 1b chronic hepatitis C virus |
Phase IIIb Topaz-II data show that 95% of the 615 patients in the trial achieved a sustained virological response at 12 weeks post-treatment after 12 or 24 weeks of treatment, a secondary endpoint |
11/17/15 |
Genfit SA |
GFT505 |
Elafibranor |
Nonalcoholic steatohepatitis |
Company will start a pivotal phase III trial by year-end; despite having missed its primary endpoint of "resolution of NASH without worsening of fibrosis" in the phase II GOLDEN-505 trial, the company will be targeting NASH resolution without worsening of the fibrosis as the phase III study's single histological surrogate endpoint |
11/17/15 |
Gilead Sciences Inc. (Foster City, Calif.) |
Zydelig |
Idelalisib |
Chronic lymphocytic leukemia |
Phase III study of Zydelig added to standard therapy will be unblinded early, as recommended by an independent data monitoring committee due to a statistically significant benefit in efficacy for progression-free survival and overall survival |
11/17/15 |
Gilead Sciences Inc. (Foster City, Calif.) |
Velpatasvir |
Pan-genotypic NS5A inhibitor |
Hepatitis C virus |
In a study evaluating the fixed-dose velpatasvir/sofosbuvir combination for 12 weeks in 740 patients with genotype 1, 2, 4, 5 or 6 HCV infection called Astral-1, it was safe, well tolerated and yelded a statistically significant overall sustained virologic response rate 12 weeks after treatment (SVR12) of 99% (95% confidence interval 97.9% to 99.6% |
11/17/15 |
Intercept Pharmaceuticals Inc. (New York) |
OCA |
Farnesoid X receptor agonist obeticholic acid |
Primary biliary cholangitis |
A study, which analyzed data from the phase III POISE trial of OCA in PBC showed a significantly lower risk of liver transplant or liver-related death in patients treated with OCA and ursodiol vs. those treated with placebo and ursodiol; researchers found that lowering alkaline phosphatase levels can help reduce the risk of liver transplant and death in PBC; OCA treatment of NASH patients in FLINT led to a statistically significant decrease in FIB-4 from baseline and a significant decrease in APRI as compared to placebo |
11/17/15 |
Janssen-Cilag International NV (Beerse, Belgium) |
Olysio |
Simeprevir |
Hepatitis C virus genotype 4 |
Preliminary results from the phase IIa OSIRIS trial of Olysio in combination with sofosbuvir showed the combo demonstrated treatment to be safe and generally well tolerated, with sustained virological response rates of up to 100% in patients treated for 12 weeks regardless of fibrosis stage and treatment history |
11/17/15 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Elbasvir/grazoprevir1 |
50 mg/100 mg once-daily tablet |
Chronic hepatitis C virus genotypes 1, 4 or 6 |
Six phase II and III trials provided a full analysis set demonstrating that treatment-naïve patients with compensated liver cirrhosis who received elbasvir/grazoprevir with or without RBV for 12 weeks achieved sustained virologic response at rates of 90% (28/31) and 98% (135/138), respectively; treatment-experienced patients who received elbasvir/grazoprevir with or without RBV for 12 weeks achieved virologic cure rates of 91% (74/81) and 89% (48/54), respectively |
11/17/15 |
Pharco Pharmaceuticals Inc. (Alexandria, Egypt) |
Ravidasvir |
Small molecule |
Genotype-4 chronic hepatitis C virus |
Data from its phase III trial of the combination of ravidasvir 200 mg with sofosbuvir 400 mg once daily for 12 weeks resulted in SVR12 rates of 98% overall; for non-cirrhotic patients, the per-protocol results to date are 100% SVR12 |
11/17/15 |
Raptor Pharmaceutical Corp. (Novato, Calif.) |
RP103 |
Cysteamine bitartrate delayed-release |
Moderate-to-severe nonalcoholic fatty liver disease |
Additional results from the CyNCh study showed there was no difference in the response rate between RP103 and placebo (28% vs. 22%, respectively; p = 0.34) |
11/17/15 |
Replicor Inc. (New York) |
REP 2139-Ca |
Combination therapy with pegylated interferon alpha-2a |
Chronic hepatitis B virus and chronic HBV and hepatitis delta virus |
Updated interim safety and efficacy data showed that previously reported HBsAg reductions with REP 2139-Ca monotherapy continued to improve during combination therapy with pegylated interferon alpha-2a, becoming > six logs in four patients, > five logs in two patients, > three logs in two patients and 0.5-2.78 logs in the remaining four patients |
11/17/15 |
Spring Bank Pharmaceuticals Inc. (Milford, Mass.) |
SB 9200 |
Oral antiviral agent that acts by modulating the host immune response to viral infections through activation of host antiviral sensor proteins, RIG-I and NOD2 |
Non-cirrhotic hepatitis C virus |
Data showed that SB 9200 positively impacted viral load in otherwise healthy, non-cirrhotic HCV patients |
11/17/15 |
Tobira Therapeutics Inc. (South San Francisco) |
Cenicriviroc |
CCR2/CCR5 inhibitor |
Nonalcoholic steatohepatitis |
Can be safely co-administered with Actos (pioglitazone HCl; Takeda Pharmaceutical Co. Ltd.) in healthy subjects despite a "modest interaction" and that dose adjustment is not required when the drugs are used in combination |
11/17/15 |
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Notes BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment. Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. For more information about individual companies and/or products, see Thomson Reuters Cortellis. | |||||