After having successfully completed phase II clinical trials, Altus had previously planned to initiate phase III trials for both ALTU-135 and ALTU-238 in the second half of this year.
However, with respect to ALTU-135, an orally administered enzyme replacement therapy, Altus now expects to perform additional manufacturing development work in advance of initiating its phase III trial in patients with pancreatic insufficiency.
To date, one of the three lots for ALTU-135 produced using the phase III manufacturing process showed lower activity for one enzyme. The company has decided to produce and test additional lots before initiating the phase III trial in order to ensure a consistent production process.
For ALTU-238, Altus’ long-acting, crystalline form of human growth hormone, the company has recently been notified by one of its suppliers that the delivery of certain equipment for the production of ALTU-238 has been delayed. Altus expects to use this time to develop and qualify additional assays prior to phase III production of ALTU-238 to ensure process reproducibility and product consistency.
Altus said it does not believe these delays are related to its proprietary protein crystallization technology, but instead to the challenges of implementing appropriate manufacturing controls and analytical methods.
“We are disappointed about these delays but we have plans in place to address these issues,” noted Sheldon Berkle, president and CEO of Altus. “We believe the most prudent action is to invest additional time now to ensure we enter our phase III clinical trials with robust manufacturing processes and drug products that are representative of the commercial product.”