Evolocumab achieved primary endpoint in TESLA study

Amgen announced that evolocumab achieved the primary endpoint of LDL reduction at 12 weeks in a cohort of patients with homozygous familial cholesterolemia in the phase 3 TESLA study.

The reduction in LDL was both statistically and clinically significant, according to a press release.

The TESLA study was a two-part phase 2/3 trial evaluating the PCSK9 inhibitor evolocumab in patients with homozygous familial hypercholesterolemia (LDL ≥130 mg/dL). The phase 3 trial evaluated the safety, tolerability and efficacy of evolocumab vs. placebo in 49 adults and adolescents aged 12 to 18 years who were on stable doses of statins and other lipid-lowering therapies. Patients were randomly assigned monthly subcutaneous evolocumab 420 mg or placebo for at least 12 weeks, with follow-up every 2 weeks for an additional 12 weeks. In addition to the primary endpoint of LDL reduction at 12 weeks, evaluated factors included mean percent LDL change from baseline, lipoprotein and apolipoprotein B levels at 6 and 12 weeks, and percent change to lipoprotein and apolipoprotein B from baseline to 12 weeks.

The evolocumab and placebo groups had similar safety profiles, according to the release. The most commonly observed adverse events among treated patients included gastroenteritis, influenza, nasopharyngitis and upper respiratory tract infection.

“We are encouraged by the results of the TESLA trial, the first phase 3 data of a PCSK9 inhibitor in homozygous familial hypercholesterolemia patients, which suggest evolocumab may offer a new treatment option for these patients who currently have significant unmet medical needs,” Sean E. Harper, MD, executive vice president of research and development at Amgen, stated in the release.

The TESLA trial is part of the PROFICO evolocumab clinical trial program of 14 studies.

Amgen will submit details of the phase 3 trial for presentation at a future medical conference, as well as for publication, according to the release.