Tranzyme Pharma

Durham drug development company Tranzyme Pharma on Tuesday announced positive results in phase II clinical trials for a new stomach treatment for diabetes patients.

Tranzyme has fast-track status from the U.S. Food and Drug Administration to evaluate its drug candidate TZP-102 in diabetic patients who have gastroparesis, a disorder in which the stomach is unable to empty food efficiently. The company said that all three doses of the treatment tested were effective, safe and well tolerated. The company is now preparing to start a 12-week study to test the treatment’s efficacy and safety in patients who have gastroparesis.

Tranzyme’s gastroparesis treatment would be an alternative to a product that carries serious side effects. Metoclopramide, the only approved treatment for gastroparesis, now carries a “black box warning.” The drug carries the risk of causing often irreversible tardive dyskinesia, a disorder characterized by involuntary body movements.

The FDA last year gave TZP-102 a fast-track designation, a status reserved for drugs that treat serious and unmet medical needs. The designation typically speeds review and approval of drugs.

Tranzyme has raised about $60 million in venture capital from investors including H.I.G. Ventures, Quaker BioVentures and Thomas, McNerney & Partners. The company earlier this month announced an agreement with Norgine giving the Netherlands-based pharmaceutical company the rights to develop and commercialize TZP-101, another gastrointestinal treatment. Under the agreement, Norgine will make an upfront payment of $8 million along with an equity investment in Tranzyme. Tranzyme is eligible to receive up to $150 million in additional milestone payments. Tranzyme employs more than 35.

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Triangle Business Journal - by Frank Vinluan