Basilea reports positive topline phase 3 results for antifungal isavuconazole
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Basilea reports positive topline phase 3 results for antifungal isavuconazole
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* Isavuconazole phase 3 invasive aspergillosis study (SECURE) meets primary
endpoint
Basel, Switzerland, September 30, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today positive topline data from the isavuconazole phase 3 invasive
aspergillosis study (SECURE). The antifungal agent isavuconazole is being co-
developed with Astellas Pharma Inc.
The randomized, double-blind isavuconazole study (SECURE) achieved its primary
objective in demonstrating non-inferiority versus voriconazole for the primary
treatment of invasive fungal disease caused by Aspergillus species or certain
other filamentous fungi. Isavuconazole was effective as determined by the
primary endpoint of all-cause mortality through day 42 in the intent-to-treat
population (N=516). The all-cause-mortality was 18.6% in the isavuconazole
treatment group and 20.2% in the voriconazole group. The 95% confidence interval
of the treatment difference between isavuconazole and voriconazole was within
the pre-specified non-inferiority margin of 10%.
In addition, the key secondary endpoint of overall success rate (composite of
clinical, mycological, radiological responses) at the end-of-therapy in patients
with proven/probable disease was similar between isavuconazole and voriconazole
(35.0% and 36.4%, respectively). This outcome was based on a blinded assessment
by the Independent Data Review Committee.
Overall drug- and non-drug-related adverse events were reported in 96.1% and
98.5% of patients in the isavuconazole and voriconazole treatment groups,
respectively. The most frequent adverse events reported were nausea, vomiting,
pyrexia (fever), diarrhoea, and hypokalaemia (deficiency of potassium in the
blood) which were reported at similar rates in both treatment groups. Study
drug-related adverse events were reported in 42.4% and 59.8% of patients in the
isavuconazole and voriconazole treatment groups, respectively.
Basilea's CEO Ronald Scott commented: "The successful completion of this study
is a major achievement and an important milestone for our company. Invasive
aspergillosis is a life-threatening disease primarily afflicting
immunocompromised patients. There is a great medical need for new antifungal
agents to treat these critically ill patients. The results from this
isavuconazole study (SECURE) represent an important step in the development of
this potential new treatment option for patients suffering from invasive
aspergillosis."
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, stated: "We are excited
about the positive topline results from the SECURE study, which is the largest
interventional trial ever conducted in patients with invasive aspergillosis. The
data from the SECURE and VITAL studies could form the basis of an initial filing
in the first part of 2014. The VITAL study is expected to provide additional
important information for the development and evaluation of isavuconazole,
particularly in patients with mucormycosis and patients with pre-existing renal
impairment."
Update on other ongoing phase 3 isavuconazole studies (VITAL and ACTIVE)
Enrollment in the open-label phase 3 isavuconazole study (VITAL) including
patients with invasive fungal disease caused by mucormycetes and other emerging
fungal pathogens and patients with aspergillosis and pre-existing renal
impairment has been completed (N=150). Based on the investigator reported data,
approximately 45 patients were enrolled with mucormycosis and a similar number
of patients were enrolled with pre-existing renal impairment. Review of
diagnosis and outcomes by an Independent Data Review Committee is ongoing.
Enrollment in the randomized, double-blind phase 3 isavuconazole study (ACTIVE),
evaluating the use of isavuconazole i.v. and oral versus caspofungin i.v.
followed by oral voriconazole for the treatment of invasive Candida infections,
is continuing.
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Monday, September 30, 2013, 4 p.m. (CEST), during which the company will discuss
today's press release.
Dial-in numbers are:
+41 (0) 58 310 50 00 (Europe and ROW)
+1 (1) 631 570 5613 (USA)
+44 (0) 203 059 5862 (UK)
A playback will be available 1 hour after the
conference call until Wednesday, October 02, 2013, 6 p.m. (CEST). Participants
requesting a digital playback may dial:
+41 (0) 91 612 4330 (Europe and ROW)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 12906 followed by
the # sign.
About isavuconazole
Isavuconazole is an investigational once daily intravenous and oral broad-
spectrum antifungal for the potential treatment of severe invasive and life-
threatening fungal infections. It is currently in phase 3 of clinical
development. Isavuconazole demonstrated in-vitro and in-vivo coverage of a broad
range of yeasts (such as Candida species) and molds (such as Aspergillus
species) as well as in-vitro activity against emerging and often fatal molds
including those that cause mucormycosis. Isavuconazole received U.S. FDA fast-
track and U.S. orphan drug designation for invasive aspergillosis. Isavuconazole
is being co-developed with Astellas Pharma Inc.
About the isavuconazole phase 3 program
The phase 3 program with isavuconazole includes three studies, SECURE, VITAL and
ACTIVE. The SECURE study is a global double-blind randomized phase 3 study,
designed to evaluate the safety and efficacy of once-daily isavuconazole versus
twice-daily voriconazole in the primary treatment of invasive fungal disease
caused by Aspergillus species or other filamentous fungi. The VITAL study is an
open-label phase 3 study of isavuconazole in the treatment of aspergillosis
patients with pre-existing renal impairment or patients with invasive fungal
disease caused by emerging and often fatal molds, yeasts or dimorphic fungi. The
ACTIVE phase 3 study is evaluating the safety and efficacy of intravenously
(i.v.) and orally administered isavuconazole versus i.v. caspofungin followed by
oral voriconazole in the treatment of invasive Candida infections.
About invasive aspergillosis infections
Invasive aspergillosis is estimated to occur in 5-13% of recipients of bone
marrow transplants, 5-25% of patients who have received heart or lung
transplants, and 10-20% of patients who are receiving intensive chemotherapy for
leukemia.[1] Mortality rates for transplant patients with invasive aspergillosis
have been reported to be between 34% and 58%.[2] Around 47% of solid organ
transplant recipients who developed invasive aspergillosis had renal
insufficiency and acute renal failure was reported for 43% of intensive care
unit (ICU) patients with invasive aspergillosis, compared to 20.5% in the
general ICU population.[2],[3]
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research and
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the company focuses on innovative pharmaceutical products in
the therapeutic areas of bacterial infections, fungal infections and oncology,
targeting the medical challenge of rising resistance and non-response to current
treatment options.
Basilea has a robust pipeline of clinical and preclinical programs. For the
ceftobiprole program in pneumonia it expects a decision from regulatory
authorities in Europe in the fourth quarter of this year. The anti-cancer
product BAL101553 in resistant tumors is anticipated to transition into phase
2a of clinical development this year following establishment of the maximum
tolerated dose in the ongoing phase 1 study. Phase 1 development is ongoing for
the Gram-negative antibiotic BAL30072, which is being developed under a contract
with the U.S. Biomedical Advanced Research and Development Authority (BARDA),
providing for funding of up to USD 89 million. Basilea continues to focus on
bringing these important products addressing resistance to patients, optimizing
value and continuing to effectively manage its financial resources.
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition, performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different from
any future results, performance or achievements expressed or implied by such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing this
communication as of this date and does not undertake to update any forward-
looking statements contained herein as a result of new information, future
events or otherwise.
For further information, please contact:
+-----------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-----------------------------+--------------------------------+
| Peer Nils Schröder, Ph.D. | Barbara Zink, Ph.D., MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com.
References
[1] Harman EM, Medscape Reference, Drugs, Diseases & Procedures, Aspergillosis
Clinical Presentation, http://emedicine.medscape.com/article/296052-overview
[2] Baddley JW et al. Factors associated with mortality in transplant patients
with invasive aspergillosis. Clinical Infectious Disease 2010 (50), 1559-1567
[3] Vandewoude KH et al. Invasive aspergillosis in critically ill patients:
attributable mortality and excesses in length of ICU stay and ventilator
dependence. Journal of Hospital Infection 2004 (56), 269-276
Press release (PDF):
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1732189]
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Datum: 30.09.2013 - 07:15 Uhr
Sprache: Deutsch
News-ID 301138
Anzahl Zeichen: 12163
contact information:
Town:
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Kategorie:
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