Altus Pharmaceuticals Successfully Completes Phase 1 Study Of Long Acting Formulation Of Recombinant Human Growth Hormone

Main Category: Pharma Industry / Biotech Industry
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Jan 2009 - 3:00 PDT

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Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced that it has finished its data analysis from a recently completed ALTU-238 Phase 1 study. ALTU-238 is being developed as a subcutaneously administered, long acting formulation of recombinant human growth hormone that employs Altus' proprietary protein crystallization and formulation technology, for patients with growth hormone deficiencies.

The ALTU-238 Phase 1c 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. In addition, the Phase 1c PK/PD data is consistent with prior ALTU-238 clinical studies that supported an ALTU-238 once-per-week dosing regimen. The Phase 1c 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.

"I am pleased to report the successful completion of our fourth clinical trial of ALTU-238. We believe the information gathered from this trial will be helpful in designing future ALTU-238 clinical studies," stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. "The results from this study support moving forward with an ALTU-238 Phase 2 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 2 trial in adults."

About ALTU-238

ALTU-238 is a long-acting subcutaneous formulation of rhGH in a ready-to-use liquid suspension formulation that employs Altus' proprietary protein crystallization and formulation technology. Altus' technology preserves the natural structure of the human growth hormone molecule without the need for polymers or encapsulation and enables administration through a fine gauge needle. Daily rhGH products are currently approved for the treatment of various growth disorders in children and adolescents and for growth hormone replacement in adults. Global sales for all rhGH products were approximately $2.8 billion in 2007.

About Altus Pharmaceuticals Inc.

Altus Pharmaceuticals, headquartered in Waltham, MA, is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders. The Company is listed on the Nasdaq Global Market under the symbol ALTU.

Safe Harbor Statement

Certain statements in this news release concerning Altus' business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to future development plans and the timing of any additional clinical studies for ALTU-238. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Altus might make or by known or unknown risks and uncertainties, including, but not limited to uncertainties as to the future success of ongoing and planned clinical trials and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Altus' reports to the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended September 30, 2008. However, Altus undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.

Altus and the Altus logo are the registered trademarks of Altus Pharmaceuticals.

Altus Pharmaceuticals