WEX Pharmaceuticals submits IND for Tectin analgesic, to analyze data from canceled phase 2b/3 study

By Angela McDaniels

Seattle, May 1 - WEX Pharmaceuticals Inc. said it filed an Investigational New Drug application with the Food and Drug Administration to begin a clinical trial of Tectin derived from tetrodotoxin, which the company is developing as an analgesic.

The randomized trial will assess the pharmacokinetics of Tectin after a single subcutaneous dose in healthy volunteers, according to a company news release.

WEX said that previously, no pharmocokinetic data was available because no established method was sensitive enough to detect Tectin, which is administered in very small doses. A pharmocokinetic study of the product is possible now that an analytical method sensitive enough to assay the product in human samples of blood and urine has been developed.

Terminated phase 2b/3 study update

The company prematurely terminated the Canadian phase 2b/3 study of Tectin in early March after an interim analysis by the data monitoring committee found that the product would not meet its primary endpoint: a statistical difference from a placebo in pain reduction.

WEX said all of the clinical sites are now closed and post-trial activities will be initiated.

In a letter to the company, the committee emphasized that their conclusion "should not be taken to exclude the possibility that the drug is an effective analgesic, or indeed, that an analgesic signal might be discerned from the existing data if other analyses are performed."

Accordingly, the company said it has developed a strategic plan to make a detailed analysis of the data generated by the phase 2b/3 study. Parameters such as decreased intake of opioids and analgesics, assessment of other pain scales such as the McGill Pain Questionnaire and the assessment of other secondary endpoints that were not examined by the committee, such as improvement of quality of life, will be evaluated in this analysis.

The analysis is expected to be completed within the next two months, and the company will then consult regulatory agencies regarding further clinical development for Tectin in refractory, malignant cancer pain, according to the release.

"After looking at some of the data, I still believe the company has the right technology to address moderate to severe inadequately controlled cancer-related pain," Howard Cohen, pain medicine specialist and director of the company, said in the release.

"We believe the clinical effects we are seeing with the drug are consistent with what we found in the previous phase 2a trial. There are some report[ed] cases where patients experienced dramatic pain reductions on Tectin and who have continued to benefit from the drug when dosed repeatedly in the long-term continuation study."

WEX is a pharmaceutical company based in Vancouver, B.C., that develops drug products to treat pain.

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