Compositions and methods for treating pancreatitis

Inventors

Meyers, Charles D. • Hubbard, Brian K. • Serrano-Wu, Michael H.

Assignees

Anji Pharmaceuticals Inc

Abstract

The present disclosure provides methods related to inhibiting or treating pancreatitis in a subject in need thereof, which include the use of a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor. The disclosed PCSK9 inhibitors and compositions including them can be used for treatment, inhibition, or prevention of pancreatitis in a subject. Treatment methods can include administering to the subject a therapeutically effective amount of a PCSK9 inhibitor.

Core Innovation

The disclosure relates to treating acute pancreatitis or chronic pancreatitis in a subject in need thereof by administering a therapeutically effective amount of a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor. The purpose is to acutely lower triglyceride-rich remnant lipoproteins, thereby reducing pancreatitis severity and duration and improving clinical outcomes. The disclosure connects the therapeutic approach to PCSK9 regulation of LDL receptors and clearance of triglyceride-rich remnant lipoproteins.

The treatment is described in the context of triglyceride-rich remnant lipoproteins that include VLDL and chylomicron remnants, and their clearance is tied to LDL receptor (LDLR) function. The disclosure frames the approach as addressing acute and/or chronic pancreatitis through PCSK9 inhibition to affect remnant lipoprotein levels. Embodiments may use human subjects and therapeutically effective administration of a PCSK9 inhibitor.

The PCSK9 inhibitor embodiments include monoclonal antibody and antigen-binding fragment modalities, including AMG145 (Evolocumab), 1D05-IgG2, SAR236553/REGN727 (Alirocumab), RN-316 (Bococizumab), LGT209, LY3015014 (Frovocimab), and RG7652. Other PCSK9 inhibitor modalities described include peptide mimetics, antisense oligonucleotide, RNAi, neutralizing PCSK9 variants, and possible small molecules, along with pharmaceutical compositions using a pharmaceutically acceptable carrier and various routes of administration including intravenous administration.

Claims Coverage

The partial content includes two independent claims, each directed to treating acute pancreatitis or chronic pancreatitis with PCSK9 inhibition while excluding cases where the acute pancreatitis is caused by an infection. The independent claims differ by whether the PCSK9 inhibitor is administered directly versus as part of a pharmaceutical composition, and both restrict the PCSK9 inhibitor to a specified list.

Across both independent claims, the central inventive concept is administering a PCSK9 inhibitor for treatment of acute or chronic pancreatitis with an explicit exclusion that acute pancreatitis is not caused by an infection, with the PCSK9 inhibitor restricted to the named agents.

Stated Advantages

Documented Applications