Altus delays phase 3 trials for ALTU-135, ALTU-238

By Elaine Rigoli

Tampa, Fla., July 24 - Altus Pharmaceuticals, Inc. said it will delay phase 3 clinical trials for ALTU-135 and ALTU-238, which the company had previously planned to start in the second half of this year.

With respect to ALTU-135, the company's orally administered enzyme-replacement therapy, Altus said it will perform additional manufacturing development work.

To date, one of the three lots for ALTU-135 produced using the phase 3 manufacturing process, showed lower activity for one enzyme.

The company has decided to produce and test additional lots before starting the phase 3 trial in order to ensure a consistent production process.

For ALTU-238, Altus' crystalline form of human-growth hormone, the company said it was notified by one of its suppliers that the delivery of certain equipment for the production of ALTU-238 has been delayed.

Altus said it will use the extra time to develop and qualify additional assays prior to phase 3 production of ALTU-238 to ensure process reproducibility and product consistency.

Altus, based in Cambridge, Mass., is a biopharmaceutical company.

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