Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Altus Pharmaceuticals, a biopharmaceutical company, has finished its data analysis from a recently completed ALTU-238 Phase I study.
Subscribe to our email newsletter
ALTU-238 is being developed as a subcutaneously administered, long acting formulation of recombinant human growth hormone that employs Altus’s proprietary protein crystallization and formulation technology, for patients with growth hormone deficiencies.
The ALTU-238 Phase Ic trial evaluated the safety, pharmacokinetic and pharmacodynamic (PK/PD) profile of a single dose of ALTU-238 compared to seven daily injections of Nutropin AQ. ALTU-238 was well tolerated in the one-week study that included 36 healthy, adult subjects, the company said.
In addition, the Phase Ic PK/PD data is consistent with prior ALTU-238 clinical studies that supported an ALTU-238 once-per-week dosing regimen. The Phase Ic trial results also confirm that the ALTU-238 material, produced at the current increased manufacturing scale, performs similar to the material used in previous ALTU-238 studies.
Georges Gemayel, president and CEO of Altus Pharmaceuticals, said: “The results from this study support moving forward with an ALTU-238 Phase II trial in pediatric subjects, which we expect to start during the first quarter of 2009. It is important to note, that we have already successfully completed an ALTU-238 Phase II trial in adults.”