Today, @VerveTx is announcing updates to our PCSK9 program:
1. voluntarily pausing enrollment in the Heart-1 trail of VERVE-101
2. prioritizing clinical development of VERVE-102 which uses a different LNP delivery system
3. announcing clinical trial application have been cleared in U.K. & Canada for Heart-2 trial of VERVE-102
4. expect initiation of Heart-2 trial this quarter
Details:
1. 13 patients dosed so far in Heart-1 trial, 6 at 0.45 mg/kg dose
2. Efficacy: up to 73% reduction in LDL-C and durability out to 270 days after single treatment
3. However, at potentially therapeutic doses, seeing laboratory abnormalities
4. last patient dosed at 0.45 mg/kg experienced a Grade 3 drug-induced transient increase in serum alanine aminotransferase as well as a serious adverse event of Grade 3 drug-induced thrombocytopenia (a drop in the platelet count)
5. Lab changes transient, reversible, asymptomatic
6. Nevertheless, have elected to pause enrollment to investigate in order understand mechanism, if means to mitigate
7. Regulators informed; IND, CTAs for Heart-1 trial remain active
8. We believe lab safety findings attributable to lipid nanoparticle delivery system
9. For now, prioritizing development of VERVE-102
10. VERVE-102 uses an LNP with an ionizable lipid that has been tested in third-party clinical trials and well-tolerated
11. VERVE-102 also adds a GalNAc liver-targeting ligand
12. Expect to start Heart-2 trial of VERVE-102 in 2Q '24
Link to PR:
ir.vervetx.com/news-releases…