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Tekmira Ebola Formulation Approved for Trials

FDA clears new formulation utilizing LNP improvements, lyophilization

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Tekmira has received clearance to proceed with the use of a more potent formulation in its TKM-Ebola Phase I clinical trial, which is expected to begin enrolling patients early next year. The company must get IRB approval of its FDA-approved clinical protocol before enrolling healthy volunteer subjects in a Phase I trial. The company plans to dose its first patient in 1Q14. TKM-Ebola, an anti-Ebola viral therapeutic, is being developed under a contract with the U.S. Department of Defense’s (DoD) Joint Project Manager Medical Countermeasure Systems (JPM-MCS).

The new formulation integrates improvements in LNP technology; the company’s preclinical data indicates that the new formulation is significantly more potent, achieving greater levels of anti-viral activity and 100% survival at significantly lower doses than earlier generation products, according to a Tekmira statement.

The company has also developed a lyophilized format of the treatment.  Lyophilization significantly increases the stability of LNP, even under extreme environmental conditions such as might be experienced in regions prone to naturally occurring Ebola outbreaks, according to Tekmira.

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