Camurus shares phase 3 results from ACROINNOVA 2 study
Betsy Goodfellow | July 16, 2024 | News story | Research and Development | Camurus, Pharmacy, acromegaly, clinical trial, injection
Camurus has announced positive results from its 52-week phase 3 open-label ACROINNOVA 2 study, which assessed the safety and efficacy of the company’s once-monthly octreotide subcutaneous (SC) depot (CAM2029).
The study included 135 patients with acromegaly, who were biochemically controlled or uncontrolled on stable doses of standard-of-care (SoC) with first generation somatostatin ligands (SRL) at screening.
The drug met its primary endpoint of safety, being well tolerated with a long-term safety profile that was consistent with SoC, and no new safety signals being identified. The most common adverse events (AEs) were mild to moderate injection site reactions and gastrointestinal events. Only two patients discontinued treatment due to AEs, these being one case of mild depression and one case of mild injection site haemorrhage.
Secondary endpoints included biochemical control rates, symptom scores and various patient-reported outcomes.
Fredrik Tiberg, president, chief executive officer and chief scientific officer of Camurus, commented: “Today’s results from ACROINNOVA 2 highlight the long-term safety profile and efficacy of octreotide SC depot in patients with acromegaly, including patients with uncontrolled disease on SoC. These data further strengthen the evidence base for CAM2029 octreotide SC depot as a new treatment option for people living with acromegaly, if approved. Regulatory reviews are ongoing in both the US and EU with a first approval decision expected from the US Food and Drug Administration (FDA) by the PDUFA action date 21 October 2024.”
Betsy Goodfellow
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