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| 2023. január 12., csütörtök 09:07 |
DEBIOPHARM APPLIES EXTENDED-RELEASE FORMULATION EXPERTISE TO REDUCE TREATMENT FREQUENCY BURDEN FOR ACROMEGALY & GEP-NET PATIENTS (part 1) |
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| Lausanne, Switzerland, 12 January, 2023 (APA/OTS) - Acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare diseases that require life-long chronic treatment. Monthly somatostatin analog (SSA) injections are the standard of care as first-line medical treatment. - Debiopharm is developing Debio 4126, a novel 3-month extended-release octreotide formulation, to optimize acromegaly and GEP-NET patient care by reducing injection frequency, which translates into an improved quality of life and less time spent with medical visits. - Debio 4126 is currently being investigated in two clinical studies. One of them (study Debio 4126-102) is a phase 1b study in patients with acromegaly or GEP-NETs. This study was designed to characterize the pharmacokinetic, pharmacodynamic, efficacy, safety, and tolerability profiles of Debio 4126 administered intramuscularly (IM) every 3 months over an extended period. |
Debiopharm (www.debiopharm.com), a Swiss-based, global
biopharmaceutical company, today announced that the first patient
was dosed with Debio 4126, a 3-month extended-release formulation of
octreotide, in their open-label, non-randomized, single-arm,
multicenter phase 1b study (Debio 4126-102). The study is composed
of two patient cohorts - 1 group of patients with acromegaly and 1
group with functioning GEP-NETs Patients will receive 4 injections
of Debio 4126 for a total treatment duration of 48 weeks.
Debio 4126 is currently the only 3-month SSA in clinical
development. The development of Debio 4126 arises from Debiopharm's
wish to leverage their modified-release Debiosphere™ technology to
alleviate the treatment burden of patients with rare diseases, such
as acromegaly and GEP-NETs, by reducing the injection frequency to 4
injections per year.
In healthy volunteers, Debio 4126, an extended-release formulation
of octreotide, exhibited good bioavailability and sustained release
for up to 3 months.[1] It has the potential to offer efficacy and
safety similar to those of marketed 1-month SSAs. If successful,
Debio 4126 will equip healthcare professionals with a new, more
convenient option for treating acromegalic and GEP/NET patients.
"Going into this 2-year long phase 1b trial, we look forward to
ascertaining the benefits of this extended-release formulation. We
believe that patient quality of life can be improved through the
substantially reduced number of injections, from 12 to 4/year,"
explained Dr Simona Ispas Jouron, Senior Medical Director,
Endocrinology & Rare Diseases at Debiopharm.
Prior to this compound, Debiopharm's extended-release formulation
expertise extends over more than 35 years with the development of
multiple formulations of agonist analogue triptorelin, benefiting
patients affected by prostate cancer, breast cancer, endometriosis,
central precocious puberty (CPP), and uterine myomas.
"The success of triptorelin is linked to our modified-release
Debiosphere™ technology that has contributed to the improvement of
the quality of life of patients treated long-term, particularly with
our 1, 3 and 6-month formulations of triptorelin and now with Debio
4126. This formulation adds significant value to an efficacious and
safe standard of care." expressed Bertrand Ducrey, CEO of
Debiopharm.
About Acromegaly
Acromegaly is a rare chronic disorder caused by excessive GH
secretion by pituitary adenomas, with more than 95% of cases being
benign.[2] The condition most commonly affects middle-aged adults,
with a slight predominance of female patients (52-60%)[3] and equal
distribution among ethnicities. The disease is clinically diagnosed
based on characteristic symptoms, including progressive skeletal and
soft tissue overgrowth, mainly at the extremities (hands and feet)
and head. Diagnosis is confirmed biochemically via increased serum
concentrations of GH and IGF-1. Acromegaly is associated with a
twofold increase in mortality relative to that expected in the
general population, mostly due to cardiovascular events. Associated
risk factors include hypertension, glucose metabolism abnormalities,
dyslipidemia, abdominal adiposity, and peripheral insulin resistance
(metabolic syndrome). Untreated acromegaly is associated with a
reduced quality of life and life expectancy shortened by
approximately 10 years.[2]
(continues)
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| 2023. január 12., csütörtök 09:08 |
DEBIOPHARM APPLIES EXTENDED-RELEASE FORMULATION EXPERTISE TO REDUCE TREATMENT FREQUENCY BURDEN FOR ACROMEGALY & GEP-NET PATIENTS (part 2) |
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| Lausanne, Switzerland, 12 January, 2023 (APA/OTS) - |
About Gastro-entero-pancreatic neuroendocrine tumors (GEP-NET)
GEP-NETs are rare and complex malignant solid tumors, derived from
neuroendocrine cells, occurring in various sites along the
gastrointestinal tract. Although these tumors have been considered
rare, the most recent data from the US Surveillance Epidemiology and
End Results show an increase of more than 400% in the incidence of
these diseases over the period from 1973 to 2004. [4] Age at
diagnosis is generally younger than 50 years, and these tumors may
arise sporadically or because of hereditary predisposition. Survival
of patients with GEP-NETs depends on the stage and histology.
Patients with well and moderately differentiated metastases have a
5-year survival probability of 35%, while poorly differentiated
metastases lead to a 5-year survival probability of 4%[4]
About Debio 4126
Octreotide is a synthetic octapeptide that mimics the pharmacology
of endogenous somatostatin (SST). Currently, octreotide is available
as immediate-release (Sandostatin®) and 4-week long-release
formulations (Sandostatin LAR®). Debio 4126 is a novel, 3-month
extended-release formulation of octreotide being developed by
Debiopharm.
Debiopharm's commitment to patients
Debiopharm aims to develop innovative therapies that target high
unmet medical needs in oncology and bacterial infections. We
identify high-potential compounds and technologies for in-licensing,
clinically demonstrate their safety and efficacy, and then select
pharmaceutical commercialization partners to maximize patient access
globally.
For more information, please visit www.debiopharm.com
We are on Twitter. Follow us @DebiopharmNews at
http://twitter.com/DebiopharmNews
Debiopharm Contact
Dawn Bonine
Head of Communications
dawn.bonine@debiopharm.com
Tel: +41 (0)21 321 01 11
References
[1] Bellon A, et al. ENEA. 2022.
[2] Chanson P, et al. Pituitary tumours: acromegaly. Best Pract Res
Clin Endocrinol Metab. 2009;23(5):555-74.
[3] Fleseriu M, et al. Acromegaly: pathogenesis, diagnosis, and
management. Lancet Diabetes Endocrinol 2022 Nov;10(11):804-826
[4] Yao, et al. Journal of clinical oncology : official journal of
the American Society of Clinical Oncology vol. 26,18 (2008): 3063-72.
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