Merck leads the new cholesterol-lowering push

Promising data on Merck & Co’s oral PCSK9 inhibitor MK-0616 – plus impressive late-stage results with its pulmonary arterial hypertension project sotatercept – added nearly $11bn to the group’s market cap yesterday. And a look at the PCSK9 pipeline shows Merck is well ahead of its oral rivals. Indeed, one of these recently dropped out, with Novo Nordisk quietly discontinuing NN6435 in the third quarter of last year following phase 2 data. At the time of publication, a spokesperson had not responded to questions about the reasons behind this decision. If eventually approved, Merck’s MK-0616 could take market share from currently approved monthly injectable PCSK9 inhibitors from Amgen and Sanofi/Regeneron, as well as Novartis’s twice-yearly therapy Leqvio. But others are going even longer acting, with a couple of gene editing contenders in early-stage development. Since the last time Evaluate Vantage carried out this analysis, however, one of these has also fallen by the wayside: Precision Biosciences said in January that it was ceasing development of PBGENE-PCSK9. A previous update noted that the group’s partner Iecure, which had been responsible for a phase 1 study, had not completed IND-enabling activities; the deal was signed in September 2021.

Selected PCSK9-targeting projects in development
Project Company Description Note
Phase 2
MK-0616 Merck & Co Once-daily oral Ph2 data at ACC 2023, ph3 planned in H2 2023
Phase 1
AZD0780 Astrazeneca   Oral NCT05384262 in healthy volunteers; data due H2 2023
VERVE-101 Verve Therapeutics One-off in vivo gene editing Heart-1 enrolling in New Zealand & UK, first data due H2 2023; US IND on clinical hold
VXX-401 Vaxxinity "Long-acting" synthetic peptide vaccine; target 2-4 per year Preclinical data at ACC 2023; ph1 slated for H1 2023
CTX330 Crispr Therapeutics One-off in vivo gene editing  
STP135G Sirnaomics SC RNAi   
Fallen by the wayside
ION449 (AZD8233) Astrazeneca/Ionis Once-monthly SC antisense Astra not taking into ph3 following ph2 Solano data
NN6435/ NNC0385-0434 Novo Nordisk Oral Company had ph2 data in Q3 2022; no longer in pipeline
PBGENE-PCSK9 Precision Biosciences/Iecure One-off in vivo gene editing Discontinued at preclinical stage
Source: Evaluate Pharma &

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