LUND, Sweden, June 20, 2019 /PRNewswire/ -- Camurus (NASDAQ
STO: CAMX), a commercial stage biopharmaceutical company
specializing in long-acting medicines for severe and chronic
disorders, announced today the acceptance by the US Food and Drug
Administration (FDA) of an Investigational New Drug
(IND) application to initiate a Phase 3 study with CAM2029
once-monthly octreotide subcutaneous depot for treatment of
acromegaly.
"We are pleased to receive the IND approval and will now proceed
to starting the pivotal Phase 3 study of CAM2029 octreotide
subcutaneous depot for the treatment of acromegaly," said
Fredrik Tiberg, President & CEO
of Camurus. "CAM2029 has the potential to become the first
long-acting octreotide product that can be conveniently
self-administered, thereby contributing to an improved quality of
life for patients with this severe and chronic disorder."
The phase 3 trial is a randomized, double-blind,
placebo-controlled, multinational, multi-center study in patients
with acromegaly and previously treated with long-acting
somatostatin analogues. Patients will be treated with CAM2029 or
placebo for 24 weeks, and the primary efficacy measure is
biochemical response, as measured by insulin growth hormone-1
(IGF-1) levels. The study will be performed at around 50 clinical
sites in the US and in Europe and
is expected to be completed early 2021.
About acromegaly
Acromegaly is a rare and chronic hormonal disorder that
occurs when the pituitary gland produces an excess of growth
hormone, often due to benign tumors on the pituitary. Acromegaly is
associated with reduced quality of life, shortened life expectancy
and an increased prevalence of cardiovascular mortality risk
factors. [1-5] The clinical symptoms of acromegaly include
progressive skeletal growth and soft tissue enlargement, mainly of
the extremities (hands and feet) and head. [6-8] The prevalence of
acromegaly in the US and Europe is
estimated to be around 8 per 100,000 [1-3]
About CAM2029
CAM2029 is a ready-to-use long-acting subcutaneous depot of
the active substance octreotide, a synthetic peptide analogue of
the natural peptide hormone somatostatin, is being developed for
the treatment of acromegaly and neuroendocrine tumors (NET).
CAM2029 is formulated with Camurus' proprietary FluidCrystal®
injection depot technology and is provided as a pre-filled syringe
equipped with an automatic needle-stick prevention device for
convenient self-administration by patients. In addition, CAM2029
provides higher (about 500%) bioavailability of octreotide in
comparison to the market leading product Sandostatin® LAR®, [9]
with the potential for improved efficacy in patients not responding
adequately to current therapies. [10] CAM2029 has been evaluated in
four clinical Phase 1 and 2 studies and shown promising results in
a Phase 2 multi-center study in patients with acromegaly and NET.
CAM2029 has been granted orphan designation by the European
Commission for acromegaly.
About the Phase 3 study
The study is a Phase 3, randomized, double-blind,
placebo-controlled, multi-center study assessing the efficacy and
safety of CAM2029 versus placebo in patients with acromegaly.
Patients who are on treatment with long-acting somatostatin
analogues and have prior evidence of active acromegaly disease will
be randomized to treatment with either CAM2029 or placebo in a
24-week double-blind treatment phase. The primary objective of
the study is to assess the superiority of CAM2029 compared to
placebo in biochemical response for IGF-1. The safety and
tolerability of CAM2029 will also be assessed, together with
patient-reported treatment satisfaction and health-related quality
of life parameters.
About Camurus
Camurus is a Swedish science-led biopharmaceutical company
committed to developing and commercialising innovative and
differentiated medicines for the treatment of severe and chronic
conditions. New drug products with best-in-class potential are
conceived based on the company's proprietary FluidCrystal® drug
delivery technologies and its extensive R&D expertise. Camurus'
clinical pipeline includes products for the treatment of cancer,
endocrine diseases, pain and addiction, which are developed
in-house and in collaboration with international pharmaceutical
companies. The company's shares are listed on Nasdaq Stockholm
under the ticker CAMX. For more information, visit
www.camurus.com.
References
- Acromegaly. National Institutes of Health. National
Institute of Diabetes and Digestive and Kidney Diseases. 2008
May;8(3924):1-10.
- Rosario P.W. Frequency of Acromegaly in Adults with Diabetes
or Glucose Intolerance and Estimated Prevalence in the General
Population. Pituitary. 2011;14:217-221.
- Holdaway I.M. et al. Factors Influencing Mortality in
Acromegaly. J Clin. Endocrin. Metab. 2004;89(2):667-674.
- Holdaway I.M. et al. A Meta-Analysis of the Effect of
Lowering Serum Levels of GH and IGF-1 on Mortality in Acromegaly.
European Journal of Endocrinology. 2009;159:89-95.
- Colao, et. al. Systemic Complications of Acromegaly:
Epidemiology, Pathogenesis, and Management. Endocrine Reviews.
2004;25:102-152.
- Schneider H et al. A Novel Approach to the Detection of
Acromegaly: Accuracy of Diagnosis by Automatic Face Classification.
J Clin Endocrin Metab. 2011;96:2074-2080.
- Katznelson L et al. Acromegaly: An Endocrine Society
Clinical Practice Guideline. J Clin Endocrinol Metab.
2014;99(11):3933-3951.
- Broder MS, et al. Endocrine practice: official journal of
the American College of Endocrinology and the American Association
of Clinical Endocrinologists. 2016;22(11):1327-35
- Tiberg F, et al. Octreotide s.c. depot provides sustained
octreotide bioavailability and similar IGF-1 suppression to
octreotide LAR in healthy volunteers. Br J Clin Pharmacol.
2015;80:460-72
- Pavel M, et al. Octreotide SC depot in patients with
acromegaly and functioning neuroendocrine tumors: a phase 2,
multicenter study. Cancer Chemother. Pharmacol.
2019;83:375–385
For more information
Fredrik Tiberg
President & CEO, Head of R&D
Tel. +46 (0)46-286-46-92
fredrik.tiberg@camurus.com
Fredrik Joabsson
Chief Business Development Officer
Tel. +46 (0)70-776-17-37
ir@camurus.com
This information is information that Camurus AB is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the managing director, at 1.00 pm CET
on 20 June 2019.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/camurus-ab/r/camurus-receives-ind-acceptance-from-the-fda-to-enter-phase-3-with-cam2029-for-treatment-of-acromega,c2845488
The following files are available for download:
https://mb.cision.com/Main/13456/2845488/1066074.pdf
|
Press
release.pdf
|