Combioxin enters into licensing agreement for its treatment against severe pneumonia

Under the Agreement, Eagle Pharmaceuticals will be solely responsible for the further clinical development of Combioxin's CAL02. They will make an upfront payment, followed by additional payments upon achievement of development milestones, regulatory approval and based upon commercial sales. Eagle expects to invest $35 million to achieve interim results, expected in the first half of 2023.

Combioxin is a Swiss-based biotechnology company dedicated to the development of first-in-class life-saving drugs for severe infections. The company is currently running two parallel programs with its lead product CAL02, designed to be an add-on therapy to antibiotics to neutralize virulence effectors (VE) produced by bacteria – VEs play a decisive role in the development of long-term, severe and fatal pneumonia complications. CAL02 consists of liposomes that capture and neutralize bacterial toxins produced by a broad range of Gram-positive and Gram-negative bacteria. Bacterial toxins play a critical role in severe, complicated, and resistant infections. They are known to dysregulate inflammation, cause organ damage and impede immune defence. Unlike traditional antibacterial drugs, CAL02 does not target bacteria directly.

“CAL02 could represent a true paradigm shift in terms of the treatment cascade for bacterial pneumonia patients. With an estimated 350,000 patients requiring treatment in the ICU in the U.S. in 2020, CAL02 could provide a significant opportunity to improve patient outcomes and save lives,” stated Judith Ng-Cashin, MD, Chief Medical Officer of Eagle Pharmaceuticals.

The first-in-human clinical trial results show a favourable safety profile when administered in combination with standard antibiotics to patients with severe community-acquired bacterial pneumonia (“CABP”) hospitalized in the intensive care unit (“ICU”). Furthermore, compared to patients under placebo, patients treated with CAL02 presented a faster clinical improvement, including a significantly faster resolution of organ dysfunctions (as per Sequential Organ Failure Assessment score).

Clinical Status and Regulatory Path Forward
The clinical development plan has been discussed with the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”). FDA and EMA each indicated no requirement of further dose-finding for Phase 2b, and that empiric use of CAL02 could be added to the standard of care antibacterial drug therapy prior to pathogen identification given its mechanism of action.

The Company plans to advance the clinical program and initiate a robust Phase 2b/3 study in the first half of 2022. CAL02 is an acute care drug, and therefore the Company expects a fast turnaround to receive individual patient results. Interim results are expected in the second quarter of 2023.

Ten years of regulatory exclusivity
Eagle anticipates ten years of regulatory exclusivity, including five years as a new chemical entity and five years as a qualified infectious disease product (“QIDP”) under the Generating Antibiotic Incentives Now (“GAIN”) Act. Eagle believes that CAL02 could be eligible for fast track and breakthrough therapy designations. In addition, Eagle believes a CAL02 new drug application for the treatment of severe CABP may qualify for priority review. The Company expects to build a meaningful patent portfolio for to this asset.

(Press release / RAN)