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Feb 8, 2013

Failures Prompt Tranzyme to Evaluate Its Future

  • Buffeted by the failure of two of its drug candidates in clinical trials, Tranzyme Pharma said today its Board of Directors agreed to explore and evaluate strategic alternatives—including selling the company or merging with another.

    “The Company has not made a decision to pursue any specific transaction or other strategic alternative, and there is no set timetable for the strategic review process,” Tranzyme said in a statement.

    The statement came less than two years after Tranzyme went public, and less than two months after the company pulled the plug on a Phase IIb study on the effects of three-times-daily dosing of its lead drug candidate, TZP-102 in patients with diabetes who have gastroparesis. The company was looking for signs of improvement over the 12-week treatment period in upper GI symptoms associated with the disease, such as nausea, vomiting, dehydration and difficulty digesting food.

    “The results are consistent with the findings of a prior Phase IIb trial in that there was a very large placebo effect and no treatment effect,” Transzyme said in a December 17, 2012, statement following the end of the latter trial, which assessed once-daily dosing.

    Earlier last year, Tranzyme suffered a double setback when its gastrointestinal drug candidate ulimorelin, co-developed with Dutch-owned Norgine, failed not one, but two Phase III trials. In one trial, ULISES 007, ulimorelin failed its primary endpoint of statistical improvement vs. placebo for GI2—time to recovery of GI function from the end of surgery to either first bowel movement or tolerance of solid food, whichever was later. In the second trial, ULISES 008, the drug failed to meet endpoints for accelerating GI recovery in patients who had undergone partial bowel resection.

    The setbacks have left Tranzyme with two drug development programs in preclinical phases: TZP-201, a motilin antagonist for chemotherapy-induced diarrhea, and TZP-301, a ghrelin antagonist for the treatment of metabolic diseases.

    Tranzyme's drug discovery has been based on its small molecule macrocyclic template chemistry (MATCH™) technology.  According to the company, MATCH enables rapid construction of synthetic libraries of drug-like macrocyclic compounds that display the high potency and selectivity of large biomolecules while maintaining the high oral bioavailability, favorable PK/ADME properties, and low cost of goods associated with small molecule drugs.

    Since Tranzyme went public in April 2011, shares in the company’s per-share price had fallen from $4 to 56 cents at close of trading yesterday on NASDAQ. Shares rose 6 cents per share, to 62 per share, in the first 10 minutes of trading this morning.

    Tranzyme said it hired two firms to assist it with the strategic review: Stifel will serve as financial advisor, while the law firm Skadden, Arps, Slate, Meagher, & Flom will serve as legal counsel.


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