Avila commences AVL-292 Phase 1 clinical study for B cell cancers and autoimmune diseases

Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs, announced today that it has initiated a phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of AVL-292, a novel, orally available, covalent drug that targets Bruton's tyrosine kinase (Btk). AVL-292 is the first product candidate to enter clinical evaluation from Avila's proprietary covalent drug platform, Avilomics™.

"Initiating clinical development of AVL-292 is an important milestone in our development of a new generation of rationally-designed, targeted covalent drugs," said Katrine Bosley, Chief Executive Officer of Avila. "By addressing a target that has been difficult for others to address successfully AVL-292 has the potential to help patients in need of new therapies for B cell cancers and autoimmune diseases like rheumatoid arthritis."

B cells are implicated in multiple diseases, and Btk plays a critical role in the signaling and proliferation of B cells. Potent, selective inhibition of Btk has the potential to be therapeutically important in the treatment of B cell-related hematological cancers such as non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as autoimmune diseases such as rheumatoid arthritis. In preclinical studies, AVL-292 selectively and potently inhibited Btk in vitro and was efficacious in a variety of different animal disease models.

The first clinical study of AVL-292, which is being conducted in the U.S., is a double-blind, placebo-controlled, single ascending dose study and will evaluate the safety, tolerability, and pharmacokinetic profile of AVL-292 in healthy volunteers. In addition, this study will use Avila's unique covalent probe technology to evaluate quantitatively the relationships among dose level, systemic exposure and occupancy of the target by AVL-292. This combination of analyses is designed to provide a powerful and rigorous understanding of AVL-292 action at the molecular and cellular levels and may serve to guide future clinical development.

"The Leukemia & Lymphoma Society is very excited about AVL-292 moving into clinical evaluation. There remains a great need for therapies that work by new mechanisms to treat patients who are fighting blood cancers, and we believe that targeting Bruton's tyrosine kinase may be an important new approach to benefit the patients we serve," said Louis DeGennaro, Ph.D., Chief Mission Officer of The Leukemia & Lymphoma Society, with whom Avila established a collaboration in March 2010.