BioCryst and Idera Merger Aims to Serve More Patients with Rare Diseases, Companies Say

The recently announced merger of BioCryst Pharmaceuticals and Idera Pharmaceuticals will strengthen the two companies’ focus on developing and commercializing treatments to serve patients with rare diseases, including angioedema, the companies said. The name of the new company has not yet been announced.

Among BioCryst’s ongoing development programs is BCX7353, a second-generation oral inhibitor of the plasma kallikrein for hereditary angioedema. The company currently has two late-stage programs for BCX7353:

• A Phase 3 trial program for the prophylactic, or preventive, treatment of hereditary angioedema (HAE) in a capsule formulation, with U.S. Food and Drug Administration (FDA) orphan drug designation;
• A Phase 2 program (NCT03240133) for the acute treatment of HAE in a liquid formulation. This trial currently is recruiting participants.

Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer and increasing the number of people who can benefit from immunotherapy.

“By merging our unique talents, experiences and assets, we instantly strengthen our ability to become a significant force for patients suffering from a broad range of rare diseases. We will also gain operational synergies and strengthen our financial position,” Vincent Milano, Idera’s chief executive officer who will lead the new company, said in a press release.

“The new company will have a robust late-stage pipeline with two Phase 3 candidates and two Phase 2 candidates, with several important catalysts for these programs anticipated in 2018. We will also have a deep early-stage pipeline that will continue to expand via our combined drug discovery capabilities and clinical expertise,” Milano added.

In May 2017, BioCryst presented results from the first interim analysis of the Phase 2 study evaluating BCX7353 as a preventive treatment for HAE (NCT02870972).

The data suggest that 350 mg of BCX7353 for 28 days significantly reduced angioedema attacks. Researchers saw a more than 80 percent reduction in angioedema attacks with peripheral symptoms or with a combination of peripheral and abdominal symptoms. The therapy was generally seen as safe and well-tolerated, with the common cold and diarrhea being the most common adverse events.

However, researchers noted that BCX7353 levels in the blood were higher than needed for effectiveness, supporting an evaluation of lower dose strategies.

More information about the merger and about those who will lead the new company can be found here. The new company will be named upon closing of the merger agreement.