Lundbeck broadens focus on neurohormonal dysfunctions with new Cushing’s disease trial

Lundbeck is exploring a new area in neurohormonal dysfunctions by initiating a phase II trial using Lu AG13909 as a potential treatment for Cushing’s disease. This marks an important step in Lundbeck’s commitment to advancing promising scientific innovations.

H. Lundbeck A/S (Lundbeck) is enhancing its research and development in neurohormonal dysfunctions.

A key part of this strategy is the development of Lu AG13909, a first-in-class monoclonal antibody (mAb) that targets the adrenocorticotropic hormone (ACTH).

By binding to ACTH with high affinity, Lu AG13909 aims to reduce elevated ACTH levels, potentially providing therapeutic benefits for individuals with neurohormonal dysfunctions.¹

In a recent development, a phase II clinical trial assessing efficacy, safety, and tolerability of Lu AG13909 as a potential treatment for Cushing’s disease, has been initiated.

“We are pleased to advance this new approach to potentially treating unmet needs in Cushing’s disease, a condition that, when uncontrolled, is debilitating and increases mortality,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck.

With the latest initiated trial, Lundbeck is currently investigating Lu AG13909 for two conditions: Cushing’s disease and congenital adrenal hyperplasia.²

These ongoing clinical trials underscore Lundbeck’s commitment to innovation and expanding treatment options for people with rare neurohormonal dysfunctions.

Lu AG13909: A potential treatment for people with Cushing’s disease
Cushing’s disease is a serious condition caused by a pituitary adenoma leading to excessive production of ACTH, which in turn stimulates the adrenal glands to produce high levels of cortisol. This hormonal imbalance results in clinical manifestations such as weight gain, fatigue, muscle weakness, hypertension, diabetes, obesity, and can lead to early death.^{3 4}

Lu AG13909, a potential cornerstone in the pharmacological treatment of Cushing’s disease, is an antibody designed to target ACTH with high precision thereby neutralising the actions of ACTH.¹ Consequently, Lu AG13909 is expected to reduce pathologically elevated ACTH signaling and thus provide a therapeutic benefit to patients with Cushing’s disease. This innovative approach may be a significant step forward in managing the disease.

Lu AG13909: Unveiling new possibilities for people with congenital adrenal hyperplasia
Congenital adrenal hyperplasia is a rare disorder characterized by an enzyme deficiency which disrupts adrenal steroidogenesis leading to cortisol and aldosterone deficiency and consequently increased ACTH levels. The increased ACTH levels stimulate the adrenal glands, leading to adrenal hyperplasia and androgen excess, causing the clinical features of congenital adrenal hyperplasia.^5-7

People with congenital adrenal hyperplasia are at risk of adrenal crisis, a life-threatening condition. The challenge lies in balancing glucocorticoid replacement therapy and controlling hyperandrogenism, with the risk of long-term consequences of glucocorticoid overtreatment.^8-11

Contacts

About H. Lundbeck A/S
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of. 

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn.

References
1. Feldhaus AL, Anderson K, Dutzar B, et al. ALD1613, a Novel Long-Acting Monoclonal Antibody to Control ACTH-Driven Pharmacology. Endocrinology 2017;158(1):1-8. doi: 10.1210/en.2016-1455

2. Clinicaltrials.gov. ID NCT05669950  [Available from: https://clinicaltrials.gov/study/NCT05669950?cond=congenital%20adrenal%20hyperplasia&term=lundbeck&checkSpell=&rank=1.

3. Gallo-Payet N, Martinez A, Lacroix A. Editorial: ACTH Action in the Adrenal Cortex: From Molecular Biology to Pathophysiology. Front Endocrinol (Lausanne) 2017;8:101. doi: 10.3389/fendo.2017.00101 [published Online First: 20170612]

4. Lonser RR, Nieman L, Oldfield EH. Cushing's disease: pathobiology, diagnosis, and management. J Neurosurg 2017;126(2):404-17. doi: 10.3171/2016.1.Jns152119 [published Online First: 20160422]

5. Claahsen-van der Grinten HL, Speiser PW, Ahmed SF, et al. Congenital Adrenal Hyperplasia-Current Insights in Pathophysiology, Diagnostics, and Management. Endocr Rev 2022;43(1):91-159. doi: 10.1210/endrev/bnab016 [published Online First: 2021/05/08]

6. Merke DP, Auchus RJ. Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency. N Engl J Med 2020;383(13):1248-61. doi: 10.1056/NEJMra1909786 [published Online First: 2020/09/24]

7. El-Maouche D, Arlt W, Merke DP. Congenital adrenal hyperplasia. Lancet 2017;390(10108):2194-210. doi: 10.1016/s0140-6736(17)31431-9 [published Online First: 2017/06/04]

8. Auchus RJ, Courtillot C, Dobs A, et al. Treatment patterns and unmet needs in adults with classic congenital adrenal hyperplasia: A modified Delphi consensus study. Front Endocrinol (Lausanne) 2022;13:1005963. doi: 10.3389/fendo.2022.1005963 [published Online First: 20221118]

9. Han TS, Walker BR, Arlt W, Ross RJ. Treatment and health outcomes in adults with congenital adrenal hyperplasia. Nat Rev Endocrinol 2014;10(2):115-24. doi: 10.1038/nrendo.2013.239 [published Online First: 20131217]

10. Lousada LM, Mendonca BB, Bachega T. Adrenal crisis and mortality rate in adrenal insufficiency and congenital adrenal hyperplasia. Arch Endocrinol Metab 2021;65(4):488-94. doi: 10.20945/2359-3997000000392 [published Online First: 20210716]

11. Pofi R, Ji X, Krone NP, Tomlinson JW. Long-term health consequences of congenital adrenal hyperplasia. Clin Endocrinol (Oxf) 2023 doi: 10.1111/cen.14967 [published Online First: 20230907]

H. Lundbeck A/S

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+45 3630 1311

info@lundbeck.com