PN2034 is an oral insulin sensitizer that acts on a novel target.

Sanofi-aventis negotiated an exclusive global license to Wellstat Therapeutics’ mid-stage type 2 diabetes therapy, PN2034, and related compounds. The deal could be worth up to $350 million to Wellstat in the form of an up-front cash payment plus development and regulatory milestones. Additional commercial milestones and royalties could follow.

PN2034 is an oral insulin sensitizer discovered by Wellstat. The drug’s ability to reverse insulin resistance in the liver of diabetic patients is currently being assessed in Phase II trials. PN2034 and its analogs reportedly act on a target that is distinct from other known types of insulin sensitizers. Wellstat says that PN2034 has also shown activity in models of fatty liver disease and other metabolic disorders.

Wellstat’s lead product is vistonuridine, an orally active prodrug of uridine. The drug has completed Phase III trials as an antidote to accidental overdose with the chemotherapy 5-fluorouracil (5-FU). Wellstat points out there are currently no licensed antidotes available for 5-FU overdose.

In May the company reported on 17 cases of 5-FU overdose for which its drug, vistonuridine, was requested and administered (within 8–96 hours of 5-FU overdose) under the FDA’s emergency-use IND provisions. Wellstat says that all 17 of the vistonuridine-treated patients recovered; a fatal outcome for at least 13 patients had been predicted due to the dose and rate of 5-FU administration.

Wellstat is separately investigating the potential use of vistonuridine as a combination therapy with 5-FU. A Phase III trial evaluating and comparing the treatment of pancreatic cancer using vistonuridine and high-dose 5-FU versus gemcitabine has been completed. Additional studies are being planned, including a Phase III trial in gastric cancer patients.

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