Study Presented at EASL
HUDDINGE, Sweden, April 1, 2011 /PRNewswire-FirstCall/ --
- Results Show Potent Antiviral Efficacy of Once Daily 150 mg TMC435 in
Hepatitis C Patients Who Have Failed Earlier Treatment, Especially in Prior
Null Responders, and Excellent Safety and Tolerability
Medivir AB (OMX: MVIR), the emerging research-based specialty
pharmaceutical company focused on infectious diseases, announces that their
partner, Tibotec has presented the results of a planned Week 24 interim
analysis of the phase 2b ASPIRE study for TMC435 in treatment experienced
hepatitis C patients in a late-breaker session at the 46th Annual meeting of
the European Association for the Study of the Liver (EASL), Berlin, Germany.
Treatment experienced patients are known to be the most difficult to
treat hepatitis C patient group.
TMC435 is a potent, once-daily, oral hepatitis C virus protease inhibitor
which recently entered clinical phase 3 studies. The study enrolled patients
chronically infected with genotype-1 hepatitis C virus (HCV) that had
previously failed treatment with standard of care therapy (peginterferon and
ribavarin). TMC435 is being jointly developed by Medivir and its partner
Tibotec.
In this Week 24 interim analysis, treatment-experienced patients who
failed peginterferon and ribavarin treatment achieved significantly greater
virologic response rates following treatment with TMC435-containing regimen
at all doses, compared with placebo. Results demonstrated that the TMC435 150
mg dose group showed the highest response, particularly in prior null
responders. In this 150 mg dose group, HCV RNA levels were undetectable at
week 24 for between 82% and 91% of the patients. Results also showed that
there was no statistically relevant difference in safety and tolerability
between the TMC435 and placebo treated groups.
Ron Long, CEO of Medivir, commented: "We are delighted that these strong
results are to be presented at such a prestigious scientific conference as
EASL. TMC435 continues to demonstrate why Medivir are so confident that
hepatitis C treatment can be significantly changed by a more convenient, once
daily protease inhibitor especially for treatment experienced patients. These
data and the recent start of phase 3 clinical studies for TMC435, represent
an exciting stage in Medivir's development as a significant player in the
infectious disease market."
On-treatment response rates are shown below. TMC12/PR48 TMC24/PR48 TMC48/PR48 TMC12/PR48 100mg 100mg 100mg 150mg (N=66) (N=65) (N=66) (N=66) HCV RNA <25 IU/mL undetectable, % (u/N) Overall population 67,7 (44/65) 59,4 (38/64) 53,8 (35/65) 63,1 (41/65) Week 4 (RVR) *** *** *** *** Prior null responders 33,3 (5/15) 50,0 (8/16) 25,0 (4/16) 35,3 (6/17) Prior partial responders 65,2 (15/23) 40,9 (9/22) 60,9 (14/23) 65,2 (15/23) Prior relapser 88,9 (24/27) 80,8 (21/26) 65,4 (17/26) 80,0 (20/25) Overall population 87,1 (54/62) 84,5 (49/58) 85,2 (52/61) 85,7 (54/63) Week 24 *** *** *** *** Prior null responders 71,4 (10/14) 83,3 (10/12) 68,8 (11/16) 70,6 (12/17) Prior partial responders 86,6 (19/22) 80,0 (16/20) 85,7 (18/21) 86,4 (19/22) Prior relapser 96,2 (25/26) 88,5 (23/26) 95,8 (23/24) 95,8 (23/24) *** Statistically significant difference versus placebo, p less then 0,001 (table continued) TMC24/PR48 TMC48/PR48 Pbo48/PR48 150mg 150mg (N=68) (N=65) (N=66) HCV RNA <25 IU/mL undetectable, % (u/N) Overall population 70,8 (46/65) 66,2 (43/65) 1,5 (1/65) Week 4 (RVR) *** *** Prior null responders 41,2 (7/17) 41,2 (7/17) 0,0 (0/16) Prior partial responders 69,6 (16/23) 68,2 (15/22) 0,0 (0/23) Prior relapser 92,0 (23/25) 80,8 (21/26) 3,8 (1/26) Overall population 90,8 (59/65) 90,3 (56/62) 51,9 (28/54) Week 24 *** *** Prior null responders 81,3 (13/16) 93,3 (14/15) 44,4 (4/9) Prior partial responders 90,9 (20/22) 86,4 (19/22) 19,0 (4/21) Prior relapser 96,3 (26/27) 92,0 (23/25) 83,3 (20/24) *** Statistically significant difference versus placebo, p less then 0,001 The ASPIRE study evaluates the effect of TMC435 in
combination with standard of care (SoC) in 462
patients infected with the difficult to treat
with (SoC). The study includes patients that have relapsed, achieved partial
response, or achieved no response (null responders) to treatment with
standard of care. TMC435 was administered once daily at a dose of either 100
mg or 150mg given for either 12, 24, or 48 weeks in combination with standard
of care. Standard of care treatment was continued until the study completion
at week 48.
As well as the late-breaker ASPIRE data presented, a further three
presentations will be made at EASL on TMC435. These include:
Oral presentation: Impact of IL28b genotype and pretreatment serum IP-10
in treatment-naive genotype-1 HCV patients treated with TMC435 in combination
with peginterferona-2a and ribavirin in PILLAR study, J. Aerssens, which
found that during 24 weeks of treatment, IL28B genotype and serum IP-10 were
predictive of response in patients receiving standard of care (peginterferon
and ribavirin) but had limited predictive value in patients treated with both
TMC435 and peginterferon and ribavirin, therefore suggesting that TMC435, a
potent, once daily oral protease inhibitor, may overcome the negative
consequences of unfavourable host genotype encountered with pegIFN/RBV.
Poster presentation No.472: Pharmacokinetics of TMC435 in subjects with
moderate hepatic impairment, V. Sekar, which found that no TMC435 dose
adjustment was necessary for patients with moderate liver impairment.
Poster presentation No.1221: Treatment outcome and resistance analysis in
HCV genotype 1 patients previously exposed to TMC435 monotherapy and
re-treated with TMC435 in combination with pegifna-2a/ribavirin, O. Lenz,
which found that viral variants in patients who had received TMC435 as a
monotherapy were no longer detected over time and successful treatment after
prior exposure to TMC435 with emergence of resistance variants was possible
in 3/5 patients who had failed interferon-based therapy.
About TMC435 in other clinical studies
TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed
by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus
infections.
Three clinical phase 3 response guided studies were recently initiated:
- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive
patients
- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive
patients
- TMC435-C3007 or PROMISE includes approximately 375 who have relapsed
after prior interferon-based treatment
In parallel to the recent start of the global phase 3-studies, TMC435 is
currently in a follow up phase in three phase 2b clinical trials
(TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1
patients that failed previous IFN-based treatment. More safety and efficacy
data from the phase 2b trials will be presented at scientific meetings later
in 2011.
A phase 3 program for TMC435 has also recently been launched in Japan.
For additional information for these studies, please see
http://www.clinicaltrials.gov/
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a
leading cause of chronic liver disease and liver transplants. The WHO
estimates that nearly 180 million people worldwide, or approximately 3% of
the world's population, are infected with hepatitis C virus (HCV). The CDC
has reported that almost three million people in the United States are
chronically infected with HCV.
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company
focused on the development of high-value treatments for infectious diseases.
Medivir has world class expertise in polymerase and protease drug targets and
drug development which has resulted in a strong infectious disease R&D
portfolio. The Company's key pipeline asset is TMC435, a protease inhibitor
which has recently entered phase 3 clinical development for hepatitis C and
is partnered with Tibotec Pharmaceuticals.
Medivir is also marketing its first product, the unique cold sore product
Xerese(TM)/Xerclear(R) which has recently been launched on the US market.
Xerese(TM)/Xerclear(R), which is also approved in Europe, is partnered with
GlaxoSmithKline to be sold OTC in Europe, Japan and Russia and with Meda AB
in North America, Canada and Mexico. Medivir has retained the Rx rights for
Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website:
http://www.medivir.com/.
For more information about Medivir, please contact: Medivir (http://www.medivir.com/): Rein Piir, CFO & VP Investor Relations Mobile: +46-708-537-292 Bertil Samuelsson, CFO Mobile: +46(70)576-13-50 M:Communications: Mary-Jane Elliott / Amber Bielecka / Katja Toon Medivir@mcomgroup.com +44(0)20-7920 2330 USA: Roland Tomforde +1-212-232-2356
No comments:
Post a Comment