Avila Therapeutics Announces positive clinical data for BTK inhibitor, AVL-292, Phase 1a studies

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Avila Therapeutics ™, Inc., a biotechnology company developed novel targeted Covalent drugs, announced that it two phase 1a clinical studies for AVL-292, its orally available, selective inhibitor of Bruton's tyrosine kinase (Btk) completed successfully. Avila presents summary of the results of the first-in-human study AVL-292-001, on the Keystone Symposium on molecular and cell biology: evolving approaches for early-stage drug discovery.

The study AVL-292-001 was a double-blind, placebo-controlled, single ascending dose trial in healthy volunteers, in this study, AVL-292 favourable safety, tolerability and pharmacokinetics shown. In addition, the trial used Avila's unique Covalent sample assess technology, the quantitative relationship between dose, systemic exposure and occupancy of the target of AVL - 292. This combination of analysis provides a powerful and rigorous understanding of the AVL-292 action at the molecular level and serves as a rational Guide to future clinical development. The clinical development of AVL-292, partially supported by an alliance with the leukemia & Lymphoma Society (LLS).

Katrine Bosley said "about 50 healthy voluntary took in these two studies, and based on this early and encouraging results, we are actively moving forward the clinical development of AVL-292, first for B cell cancer treatment, expected to be mid 2011 initiate 1B study with a phase", Chief Executive Officer of Avila. "The successful conclusion of this first clinical trial is an important milestone for Avila and our Covalent drug platform as we show our Covalent drug candidates, AVL-292 positive results and progress."

"LLS's goal in establishing our cooperation with Avila a year ago was, speed up the development of AVL-292 as a treatment for blood cancers." "We have impressed by the speed with which Avila to the BTK Covalent drug program at this time in development, has been", said Louis DeGennaro, PhD., LLS chief mission Officer. "Patients with B cell tumors need new treatment options and it is our sincere hope that AVL-292 successfully in future clinical studies."

In an oral presentation on the keystone with the title "Bruton tyrosine kinase of Bank to bed: covalently silencing of B cells with AVL-292", Juswinder Singh, PhD., co-founder and Chief Scientific Officer at Avila Therapeutics, presents data from the first clinical trial of AVL-292.

Highlights of the data presented are:

-AVL-292 was shown, safe and well tolerated in General

-Five planned dose administered to subjects in all cohorts AVL-292.

-AVL-292 was well absorbed with good systemic exposure and demonstrated a dose proportional pharmacokinetic profile at all dose levels (from 0.5 up to 7.0 mg / kg) with low inter-subject variability

-AVL-292 reach statistically significant levels of target assignment at all doses, with > 80% BTK website utilization objective at doses as low as 1.0 mg / kg

About AVL-292 and Bruton's tyrosine kinase (Btk)

AVL-292 is a novel, orally available, Covalent drug that targets the Bruton tyrosine kinase (Btk). Inhibition of the BTK is a promising approach, new treatment of diseases that are controlled by B cells, including certain types of cancer and autoimmune diseases. AVL-292 selectively bind and inactivate covalently attached to BTK and their activity to bring silence. This unique mechanism of action gives more objective selectivity and a longer duration of action as typical of conventional small molecule drugs. In preclinical studies AVL-292 potently and selectively BTK and B-cell receptor inhibited signaling in vitro and in a variety of animal disease models was effective. AVL-292 is in the clinical development and two phase 1a so far has successfully completed clinical studies.

BTK plays a crucial role in the activation of the normal B-lymphocytes and contributes to the distribution and survival of B cells in certain types of cancer. AVL-292, may irreversibly inhibit his ability, and BTK, silenced to bring a new therapeutic best-in-class option for the treatment of B cell hematological cancers, including non-Hodgkin's Lymphoma (NHL) and B-cell of chronic lymphocytic leukemia (B-CLL), as well as autoimmune diseases like rheumatoid arthritis in the B cells is known, that the disease contribute pathology present.

Source:
Avila Therapeutics ™, Inc.