Programs

LOXO-305

LOXO-305 is an investigational, novel, selective non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells known as B-cells and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia, mantle cell lymphoma and marginal zone lymphoma.

Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies has been limited by acquired resistance, most commonly through BTK C481 mutations, and intolerance, due to off target inhibition of other cellular targets.[1],[2] LOXO-305 was designed to reversibly bind BTK, preserve activity in the presence of the C481 acquired resistance mutations, and avoid off-target kinases that have complicated the development of both covalent and investigational non-covalent BTK inhibitors.

LOXO-305 is currently being studied in a global Phase 1/2 clinical trial.

For more information about the LOXO-305 clinical trial, please refer to clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email clinicaltrials@loxooncology.com.

LOXO-305 is currently being evaluated in a global, multi-center Phase 1/2 trial in patients with previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin’s lymphomas (NHL).

For more information about the LOXO-305 clinical trial, please refer to clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email clinicaltrials@loxooncology.com.

Policy for Access to Investigational Agents

Loxo Oncology is committed to helping patients who have not responded to available therapies and may benefit from its investigational therapies. Loxo Oncology’s Policy for Access to Investigational Agents describes the principles that the company will follow when considering a request, view here.

Procedure for Requesting Expanded Access and Response Times 

  1. Treating physicians interested in treating a patient with a Loxo Oncology investigational drug that is in active clinical development must submit the Loxo Oncology Expanded Access Program request form to clinicaltrials@loxooncology.com. Treating physicians should take care not to include identifying personal health information (PHI). 
  2. Loxo Oncology will acknowledge a satisfactorily completed and submitted request via email within 5 business days.   
  3. Making a request does not guarantee the granting of access to an investigational drug. Loxo Oncology will review the request in the context of its Policy for Evaluating Access to Investigational Agents Outside of Loxo Oncology Clinical Trials. Loxo Oncology will attempt to make a decision to grant or deny the request, or ask for more information, within 10 business days.

Questions about Loxo Oncology’s policy and procedures for expanded access, or about expanded access to Loxo Oncology investigational drugs, should be sent by email to: clinicaltrials@loxooncology.com.