Dive Brief:
- Cyon Therapeutics has entered into a licensing agreement with Novartis for the big pharma's PCSK9 inhibitor LGT209.
- While financial details of the deal were not disclosed, Cyon gets the worldwide rights to LGT209 for the use in systemic inflammatory response syndrome (SIRS). The deal includes undisclosed regulatory and commercial milestones .
- With a successful Phase 1 trial under its belt that showed the drug was well-tolerated and worked in lowering cholesterol, Cyon expects to move immediately into Phase 2 clinical studies.
Dive Insight:
Cyon noted that sepsis is still a large unmet need and that PCSK9 protein levels play a key role in the problem. Cyon is evaluating several predictive biomarkers in an effort to find the right patient population for the drug. The company will recruit patients who have early disease in an order to avoid higher rates of mortality.
"Cyon's novel discovery work highlighting a key role of PCSK9 levels and genotype with predisposition to organ failure in the ICU setting, can now advance immediately into a Phase II RCT of this anti-PCSK9 antibody. LGT-209 could be positioned to be a broad spectrum complement to all antibiotics in severe infection", said Cyon CEO John Boyd in a statement.
The PCSK9 class has made headlines over the last few years as Amgen and Sanofi/ Regeneron, respectively, battled to bring their highly-anticipated drugs to market for treatment of high cholesterol. The drugs gained approval from the U.S. Food and Drug Administration last summer, but with a limited label that only reaches a small patient population that does not do well on statins. Both drugs, Repatha (evolocumab) and Praluent (alirocumab), have had disappointing launches and faced pushback from the public regarding their high price tags.
Multiple other big pharmas have been developing drugs for the highly-anticipated class, but enthusiasm has waned and companies have dropped their PCSK9 prospects from development. Earlier this month, Pfizer noted during a second quarter earnings call that it would stop development of its oral PCSK9 inhibitor due to the competitive landscape.