Tekmira Pharmaceuticals announced today that it has decided to delay the start of the next clinical trial of TKM-ApoB, which is being developed as a treatment for patients with high LDL cholesterol who are not well served by current therapy.
The company had planned to start the Phase I-II clinical trial for TKM-ApoB by the end of this year, but in non-clinical studies, the performance characteristics of the specific lipid nanoparticle formulation did not meet expectations for the intended application, according to a company statement. It emphasizes that the delay has no impact on any of its other programs and that there are several
alternative LNP formulations being evaluated for TKM-ApoB development.
"We are not satisfied with the performance of our current TKM-ApoB LNP formulation for its intended use and we are going to focus on selecting an alternative formulation and availing ourselves of our existing improvements in formulation technology before resuming clinical development. In addition to our own internal product candidates, our partners continue to make excellent progress using our LNP technology for a variety of applications and, given our leadership position in the field, we believe we are very well positioned to continue expanding our partnerships and research collaborations," says Mark Murray, Tekmira's president and CEO.
The company also reported that it has formally initiated the development of TKM-Ebola under the $140 million contract awarded by the U.S. Government's Transformational Medical Technologies Program.
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