ScinoPharm Taiwan, Ltd and CVie Therapeutics Limited (CVie) jointly announced the initiation of a discovery and development collaboration to identify the new generation compound to Istaroxime, CVie’s acute heart failure treatment currently in late phase IIb trials in Italy and China. This collaboration marks the first time ScinoPharm will collaborate with an external partner, CVie, from a discovery (pre-IND) perspective.

According to the agreement, the primary goal of the new generation compound is to possess oral bioavailability while maintaining Istaroxime's unique dual luso-inotropic function. The successful candidate may be positioned for both acute and chronic heart failure and is expected to have a larger market than that of Istaroxime. ScinoPharm will provide medicinal chemistry design and synthesis, while CVie will apply their vast biological know-how to screen and identify the new candidate. Further in vivo efficacy will be conducted in animal models of chronic heart failure. When the new compound enters the clinical development phases, ScinoPharm aims to be the primary chemistry, manufacturing, and controls (CMC) service provider to furnish material for clinical phases and beyond.

ScinoPharm has a strong relationship with CVie for the supply of API for CVie’s clinical trials. CVie's long-standing expertise in the indication of heart failure via small-molecule therapeutics furnishes a solid foundation on which to discover the desired new generation compound to Istaroxime. ScinoPharm's experience in drug discovery, chemistry route development, and CMC operations is a perfect complement to CVie's existing assets and resources.

ScinoPharm CEO Dr. Yung Fa Chen stated, “ScinoPharm is transforming into a full-scope specialty pharma based on our core competencies of strong R&D and cGMP manufacturing in high-entry barrier APIs. This collaboration with CVie signals ScinoPharm’s strategic move into the new drug development field. From both scientific and business perspectives, we are very excited for this alliance.”   

CVie President and COO, Dr. Lit-Fui Lau, said, “The partnership between ScinoPharm and CVie will take advantage of the strengths of both companies toward the discovery of the orally available istaroxime analogs for the treatment of acute and chronic heart failure. It creates a win-win situation for both companies and exemplifies a productive collaborative model in discovering novel medicines of value to patients.”

Istaroxime is a first-in-class luso-inotropic agent under development for the treatment of acute decompensated heart failure. It possesses a unique dual mode of action, combining inotropic (myocyte contraction) and lusotropic (myocyte relaxation) effects. Istaroxime is a potent positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+-ATPase. In addition, it stimulates myocardial relaxation through activation of the SERCA 2a calcium pump on the sarcoplasmic reticulum and reduction in cytoplasmic calcium. Based on its mechanism of action, preclinical studies and early clinical findings, it is anticipated that Istaroxime will have minimal deleterious effects of conventional inotropes, i.e., increased heart rate, increased oxygen consumption, increased risk of arrhythmia and hypotension.

CVie is a Taiwan-based joint venture founded in 2013 by Lee’s Pharmaceutical Holdings Limited and renowned venture capitals from the US and Taiwan. It is a stand-alone drug development company specialized in cardiovascular diseases.

ScinoPharm Taiwan, Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With research and manufacturing facilities in both Taiwan and China, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities for brand companies as well as APIs for the generic industry.