Medivir Announces Positive 24-week Interim Data of TMC435 from the
ASPIRE Study (C206)
~ Once daily novel therapy in treatment-experienced Hepatitis C patients
~
Highlights of the study:
TMC435 added to standard of care:
- increased the response rates and antiviral efficacy, which
progressed through to week 24.
- increased the number of patients with undetectable Hepatitis C
Virus (HCV) levels through week 4, 12 and 24
- was safe and well tolerated
Huddinge, Sweden - Medivir AB (OMX: MVIR), the emerging research-based
specialty pharmaceutical company focused on infectious diseases
announces today positive top-line 24-week interim data from the Phase 2b
ASPIRE (C206) study of TMC435 in treatment-experienced hepatitis C
patients. The results demonstrate the potent and consistent antiviral
efficacy of TMC435 in patients who had failed earlier treatment with
peg-IFN and ribavarin (standard of care), as well as an safety and
adverse event profile for TMC435 that is consistent with what we have
previously reported in the phase 2b PILLAR C205 study. TMC435, a
hepatitis C protease inhibitor, dosed once daily (q.d.) is being
developed jointly by Tibotec Pharmaceuticals and Medivir.
The ASPIRE study evaluates the effect of TMC435 in combination with
standard of care in 462 patients infected with the difficult to treat
genotype-1 hepatitis C virus who had undergone and failed prior
treatment with standard of care. 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.
Overview of the ASPIRE (C206) Week 24 Interim Study Results
The week 24 interim analysis was performed when all patients completed
24 weeks of treatment or discontinued earlier. An Intention-to-Treat,
ITT, analysis was performed including all patients who took at least one
dose of TMC435.
In the interim analysis patients treated with TMC435 and standard of
care demonstrated high response rates and antiviral efficacy in all
patient groups up to and including week 4, 12 and 24.
In the relapser group 81%, 92% and 94% of patients taking TMC435 and
Peg-IFN and RBV achieved undetectable HCV RNA levels at week 4, week 12
and week 24 respectively. For the partial responder group 62%, 84% and
86% achieved undetectable HCV RNA levels at week 4, week 12 and week 24
respectively.
The null responder group also demonstrated significant response rates
with 38%, 64% and 78% of patients taking TMC435 and Peg-IFN and RBV
achieving undetectable HCV RNA levels at week 4, week 12 and week 24
respectively. All patients continue on active treatment up until week
48.
In the table below the TMC435 data pooled and all data are taken into
account at the specific time point.
An Intention-to-Treat analysis of Virologic Response: HCV RNA<25IU/mL
undetectable
Relapser* Partial responder** Null responder**
(%) TMC435 Placebo TMC435 Placebo TMC435 Placebo
N = 158 N = 27 N = 138 N = 23 N = 100 N = 16
RVR 81 4 62 0 38 0
WEEK 4
cEVR 92 31 84 10 64 21
WEEK 12
WEEK 24 94 83 86 19 78 44
*Relapser: undetectable at EOT but detectable within 24 weeks of
Follow-up
**Partial response: >2 log reduction at Week 12 but not achieving
undetectable at EOT
***Null response: <2 log reduction in HCV RNA at Week 12
Safety and Tolerabillty
An Intention-to-Treat analysis was performed including all patients who
took at least one dose of TMC435. TMC435 was generally safe and well
tolerated and the results were consistent with the previously reported
phase 2b PILLAR C205 study. Significant decreases in transaminases (ALT
and AST) were observed in all TMC435 treatment groups. The two most
frequently reported AEs were fatigue and headache, with comparable
results shown from the placebo group.
% All TMC435 Placebo
N = 396 N = 66
Fatigue 41 42
Headache 33 33
Commenting on the results, Ron Long, CEO of Medivir said, "We are
extremely encouraged and excited by the pronounced efficacy and
advantageous safety of TMC435 in these difficult-to-treat patients that
are in a great need of new and improved treatment options. We are now
looking forward to the next important development milestone for TMC435,
the start of phase 3 clinical trials in treatment-naïve patients in
early 2011.”
Conference call
A conference call will take place at 15:00 (GMT) / 16:00 (CET) / 10:00
(EST) to discuss the Phase 2b TMC435 ASPIRE (C206) data announced
today.
Please dial: UK: +44 (0)20 7906 8535, Sweden Access Number: +46 (0)85
063 9549 or US Access Number: +1 703 865 2821, no passcode is required.
A seven day replay of the conference call can be accessed via: UK: +44
(0)20 3364 5943, Sweden: +46 (0) 20 089 6353, US: +1 866 286 6997,
please quote the passcode 281259#.
For more information about Medivir, please contact:
Medivir (www.medivir.se (http://www.medivir.se))
Rein Piir, CFO & VP Investor Relations, Mobile: +46 708 537 292
M:Communications
Europe: Mary-Jane Elliott / Emma Thompson / Amber
Bielecka, Medivir@mcomgroup.com (Medivir@mcomgroup.com), +44(0)20 7920
2330
USA: Jason Marshall, +1 212 897 5497
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. Medivir has a strong R&D portfolio
and has recently launched its first product Xerese™/Xerclear™. Medivir's
key pipeline asset, TMC435, a protease inhibitor, is in phase 2b
clinical development for Hepatitis C and is partnered with Tibotec
Pharmaceuticals.
Xerese™/Xerclear™ is an innovative treatment for cold sores, which has
been approved in both the US and Europe. It is partnered with GSK to be
sold OTC in Europe and Russia and with Meda in North America. Medivir
has retained the Rx rights for Xerclear™ in Sweden and Finland.
For more information about Medivir, please visit the Company's website:
www.medivir.se (http://www.medivir.se).
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 TMC435 clinical trial programs
TMC435 is a once daily protease inhibitor jointly developed by Medivir
and Tibotec Pharmaceuticals to treat hepatitis C virus
infections. TMC435 is currently being studied in three phase 2b clinical
trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naïve
and in G1 patients that failed previous IFN-based treatment. TMC435 is
planned to enter phase 3 studies early 2011.
PILLAR Study (TMC435-C205)
TMC435-C205 is an ongoing randomized double-blind global phase 2b study
in 386 genotype-1 treatment-naïve patients. It evaluates once daily
treatment of TMC435 with different doses and durations given in addition
to standard of care treatment, consisting of ribavirin and
pegIFNalpha-2A. Week 24 interim results were presented as a late-breaker
oral presentation at AASLD 61st Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD) in Boston, MA.,
USA.
ASPIRE Study (TMC435-C206)
TMC435-C206 is an ongoing randomized double-blind global phase 2b study
in 462 genotype-1 treatment-experienced patients. It evaluates once
daily treatment of TMC435 in with different doses of given in addition
to standard of care treatment, consisting of ribavirin and
pegIFNalpha-2A.
DRAGON Study (TMC435-C215)
TMC435-C215 is an ongoing Japanese phase 2b study in 92 genotype-1
treatment-naïve patients. It evaluates once daily treatment of TMC435
with different doses and durations given in addition to standard of care
treatment, consisting of ribavirin and pegIFNalpha-2A.
Opera-2 (TMC435-C202)
TMC435-C202 is a completed phase 2a study in treatment-naïve genotype 2
to 6 HCV patients. It is a once daily treatment of TMC435 during seven
days, at 200 mg. Subsequently, patients could continue with SoC
treatment consisting of pegylated interferon and ribavirin upon
agreement with the study doctor.
Medivir Announces Positive 24-week Interim Data of TMC435 from the ASPIRE Study (C206)
| Source: Medivir AB
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