Intra-Cellular's Caplyta replicates depression success with second Phase III win

2024-06-18

临床结果临床3期上市批准细胞疗法

Intra-Cellular Therapeutics' antipsychotic Caplyta (lumateperone) has duplicated its success in treating major depressive disorder (MDD), achieving a second Phase III win just two months after its initial triumph. The data solidifies Caplyta's efficacy and safety profile as a potential new contender in MDD, fueling blockbuster hopes for the drug.

On Tuesday, Intra-Cellular reported that Caplyta met the primary and key secondary endpoints in the 480-patient Study 502 when used as an adjunct to antidepressants. The 42mg dose provided a 4.5-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 6 compared to placebo. Patients who received Caplyta in addition to standard antidepressants achieved an MADRS improvement of 14.7 points, compared to an improvement of just 10.3 points seen with placebo.

"These results, further support our vision for Caplyta to become a leading option for patients and providers across mood disorders," said CEO Sharon Mates. The success follows April's first Phase III win in the Study 501 trial, where Caplyta demonstrated a 4.9-point MADRS advantage over placebo when used as adjunctive therapy to antidepressants.

Buyout target

With this second late-stage success, RBC Capital Markets analyst Brian Abrahams forecasts a "straightforward path for approval and commercialisation" in MDD that could expand Caplyta revenues with a $1.7-billion additional opportunity and bring its total US sales to more than $3 billion annually. The drug, an atypical antipsychotic of the butyrophenone class, was originally approved by the FDA in 2019 as a once-daily oral treatment for schizophrenia, and then expanded to include bipolar depression in 2021.

"With consistent, strong positive data...[we] see continued appreciation potential for shares to better reflect the value and scarcity of their de-risked, likely multi-blockbuster asset in the neuropsych space," Abrahams stated, suggesting a potential takeover could even emerge down the road.

In an interview with FirstWord in April after the Study 501 readout, key opinion leader (KOL) Christoph Correll said the data boded well for Study 502 and that Intra-Cellular likely wouldn't need to wait for results from a third trial – the open label roll-over Study 503 assessing long-term safety – before seeking a label expansion. For more, see – KOL Views Q&A: Intra-Cellular's Caplyta emerges as a threat to the established order in MDD.

Indeed, the company said it now plans to submit a supplemental new drug application for Caplyta's in MDD in the second half.

Eating away at Vraylar, Rexulti

Caplyta also exhibited a favourable safety profile. Pooled safety data from both studies 501 and 502 showed mostly mild-to-moderate side effects like dizziness, dry mouth, somnolence and nausea that resolved over the course of the trials, Intra-Cellular said.

Moreover, the lack of metabolic issues like weight gain could help differentiate it from antidepressants like AbbVie's Vraylar (cariprazine) and Rexulti (brexpiprazole) from Otsuka and Lundbeck. "Caplyta will cannibalise mostly Vraylar and Rexulti," Correll predicted. From an efficacy standpoint, Vraylar led to a 2.1- to 2.6-point improvement in symptoms compared to placebo on the MADRS scale, while Rexulti bested placebo by 2 to 3.2 points.

See – KOL Views Q&A: Expert previews a changing treatment landscape ahead for MDD.

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