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Karen Mena

Karen Mena

Vice President, Clinical Operations

Karen Mena is a seasoned clinical operations leader with over 28 years of experience in the biotech and pharmaceutical industry, leading complex clinical trials through all phases of development. Her expertise spans a range of therapeutic areas, including infectious disease, pulmonology, hematology/oncology, cardiology, and reproductive health. Prior to joining Clarametyx, Karen held senior leadership positions at Pulmocide, Cidara Therapeutics, Achaogen, and Cerexa.   Earlier in her career, Karen contributed to key research projects at Genitope, Stanford University, and the California Department of Health. Her work was instrumental in supporting multiple drug approvals, including REZZAYO®,  TEFLARO®, and the orphan drug BabyBIG®. She holds a B.A. in Molecular & Cell Biology from the University of California, Berkeley, and completed a post-baccalaureate program in Medicine at the University of California, San Francisco.

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Clarametyx Expanded Access Policy

Clarametyx Biosciences is a clinical stage biopharmaceutical company committed to developing novel immune-enabling therapies for serious or difficult-to-treat respiratory diseases.

“Expanded access” refers to use of an investigational drug outside of a clinical trial, where the use of the drug is for treatment, rather than gathering data in support of a marketing application.

The main goal of ongoing clinical trials for our investigational agent, CMTX-101, is to gain information about the drug’s safety and efficacy to submit an application to Health Authorities in support of approval to market CMTX-101. For this reason, Clarametyx believes that direct enrollment in a clinical trial is the preferred route of access to a drug, for which we are continuing to develop data on safety, efficacy and tolerability. We believe expanded access outside of a clinical trial may interfere with the conduct of ongoing trials and may disrupt the progress of our development programs, which could potentially delay access to other patients in need.

For this reason, Clarametyx is not making its investigational drugs available on an expanded access basis at the present time. We plan to re-evaluate this policy in the future as additional information becomes available from ongoing clinical trials.

If you have any questions about this policy or would like information about how to participate in our clinical studies, please contact us at info@clarametyx.com. More information on our ongoing clinical trial is available at ClinicalTrials.gov (http://www.clinicaltrials.gov, NCT06159725).

As authorized by the 21st Century Cures Act, Clarametyx may revise this expanded access policy at any time.