Sanofi Acquires Greater China Rights to Plozasiran, an Investigational RNAi Therapeutic for Cardiovascular Metabolic Diseases, from Visirna Therapeutics
Sanofi
Pharmaceutical Manufacturer
Visirna
siRNA Drug Developer
On August 1, Sanofi announced its collaboration with Visirna, a subsidiary of Arrowhead.（Visirna Therapeutics）Sign an Asset Purchase AgreementVisirna is currently developing and commercializing four of Arrowhead's cardiovascular metabolic drug candidates in the Greater China region. According to the agreement,Sanofi to Obtain Rights to Develop and Commercialize Plozasiran Sodium Injection in Greater China。
Source: Sanofi Official WeChat
After the closing of the Asset Purchase Agreement, Visirna will acquire Sanofi.$130 million upfront payment`, and will be eligible to receive up to`Additional milestone payments of $265 millionArrowhead is entitled to receive royalties on net sales of Pralicranib in the Greater China region.
Pleisiran Sodium, formerly known as ARO-APOC3, is a first-in-class investigational RNA interference（RNAi）Therapy Aimed at Reducing Apolipoprotein C-III（APOC3）Generation. APOC3 is a triglyceride-rich lipoprotein（TRL）A component part, and also a key regulator of triglyceride metabolism. APOC3 increases triglyceride levels in the blood by inhibiting the breakdown of TRL by lipoprotein lipase and the uptake of TRL remnants by receptors in the liver. The therapeutic goal of Plasil sodium is to reduceLow APOC3 levels, thereby reducing triglyceride levels and restoring lipids to a more normal level.
In Greater China,Pulesiran SodiumFamilial Chylomicronemia Syndrome (FCS) and SevereHypertriglyceridemiaPotential treatment options for (SHTG).
Visirna has completed the research drug Pulrisaran Sodium treatmentChinese FCS PatientsA Phase III Clinical Trial（CTR20231418/NCT05902598）, the trialSuccessfully achieved the primary efficacy endpoint and all key secondary endpointsVisirna subsequently submitted a New Drug Application (NDA) to the NMPA for volanesorsen sodium injection for the treatment of FCS. Volanesorsen sodium for the treatment of FCS patients has also received Breakthrough Therapy Designation and Priority Review status from the NMPA.
Multiple clinical studies have shown that the investigational drug volanesorsen sodium injection can reduce triglyceride levels and various atherogenic lipoproteins in patients with familial chylomicronemia syndrome (FCS), severe hypertriglyceridemia (SHTG), and mixed hyperlipidemia.
So far, Pulesilan SodiumTolerability was generally good., The adverse events reported during treatment generally reflect the comorbidities and underlying conditions of the study population. Across multiple clinical studies and different study populations, the most common treatment-emergent adverse events for the proposed 25 mg dose included coronavirus disease 2019 (COVID-19), upper respiratory tract infection, headache, type 2 diabetes, and abdominal pain.
Volanesorsen Sodium Injection is currently undergoing relevant clinical studies in the SUMMIT program, including the Phase III clinical trial PALISADE study for FCS patients, the Phase II and III clinical trials SHASTA study for SHTG patients, and the Phase II and III clinical trials MUIR study for patients with mixed hyperlipidemia.
Volanesorsen Sodium Injection for the treatment of FCS patients has been granted by the U.S. FDABreakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation, as well as the orphan drug designation granted by the European Medicines Agency. The marketing authorization application for the investigational drug volanesorsen sodium injection for the treatment of FCS has been submitted to multiple global regulatory agencies, but it has not yet received any approvals or authorizations for the treatment of any diseases.
