Sweden-based biotech Camurus shared positive Phase III trial data for CAM2029, one of its lead candidates, in patients with the rare hormonal disorder acromegaly.
CAM2029 is an investigational once-monthly octreotide subcutaneous (SC) depot, designed for enhanced octreotide exposure. It is administered once a month via a convenient prefilled autoinjector pen to facilitate easy self-administration by patients.
Octreotide is a synthetic analog of somatostatin, a hormone in the body that inhibits the release of several other hormones, including growth hormone (GH), glucagon and insulin. Due to its ability to mimic somatostatin, octreotide is used to treat various conditions associated with excessive hormone production.
Acromegaly develops when the pituitary gland produces excess GH during adulthood. This overproduction of GH leads to an increase in the size of bones and tissues, most noticeably in the hands, feet and face. Excess GH stimulates the secretion of insulin-like growth factor-1 (IGF-1) from the liver, which causes most of the clinical manifestations of acromegaly. The condition usually progresses slowly, and because of its gradual nature, it often goes undiagnosed for years.
With early diagnosis and appropriate treatment, symptoms of acromegaly can be managed, and complications can be minimized. However, if left untreated, acromegaly can lead to serious health problems, including type 2 diabetes, high blood pressure, cardiovascular disease and arthritis. Early treatment can improve quality of life and reduce the risk of these complications.
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The Phase III ACROINNOVA 2 study evaluated the safety and efficacy of CAM2029 in a total of 135 patients with acromegaly who were biochemically controlled or uncontrolled on stable doses of standard-of-care with first-generation somatostatin ligands (SRL) at screening.
The study met its primary endpoint of safety over 52 weeks of treatment, as octreotide SC depot was well tolerated with a long-term safety profile consistent with that of standard-of-care (SoC) with the first-generation SRL extended-release octreotide and lanreotide. No new safety signals were observed.
Secondary endpoints included biochemical control rates, symptom scores and several patient-reported outcomes. Octreotide SC depot treatment over 52 weeks led to significant increases in treatment response rates of 12.7 percent in the overall population, and 22.8 percent in new patients compared to SoC at baseline. Roll-over patients, with controlled IGF-1 values at the SoC baseline, maintained or regained biochemical control during treatment.
According to the company’s data, octreotide SC depot also continuously improved acromegaly symptom scores and patient-reported outcomes, including treatment satisfaction, acromegaly quality of life and self-injection assessment scores compared to SoC at baseline.
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Camurus is also developing CAM2029 for the treatment of gastroentero-pancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).
Crinetics Pharmaceuticals is developing paltusotine (CRN00808), an investigational oral somatostatin receptor agonist designed to maintain normal IGF-1 levels in acromegaly patients. This drug is currently in Phase III trials.
In 2020, Chiasma (now acquired by Amryt) received US Food and Drug Administration (FDA) approval for Mycapssa (octreotide), a somatostatin analog for long-term maintenance treatment for acromegaly.
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