Common use of Phase 2 Clinical Program Clause in Contracts

Phase 2 Clinical Program. The Phase 2 study will be a proof-of-concept (POC) study assessing the effects of several doses of BA058 on markers of bone turnover and BMD. The primary objectives of this study are to assess the dose response of BA058, compare BA058 to Forteo®, and to select the BA058 doses that will be used in subsequent efficacy studies. The strategic goal for this trial will be to confirm the ability to deliver more effective anabolic doses of BA058 with good safety and tolerability than is possible with Forteo, with clinical endpoints that demonstrate a wider anabolic window for BA058 (i.e. greater effects on BMD at 3 months, and a higher ratio of bone formation vs. resorption) compared to Forteo.

Phase 2 Clinical Program. The Phase 2 study will be a proof-of-concept (POC) study assessing the effects of several doses of BA058 on markers of bone turnover and BMD. The primary objectives of this study are to assess the dose response of BA058, compare BA058 to Forteo®, and to select the BA058 doses that will be used in subsequent efficacy studies. The strategic goal for this trial will be to confirm the ability to deliver more effective anabolic doses of BA058 with good safety and tolerability than is possible with Forteo, with clinical endpoints that demonstrate a wider anabolic window for BA058 (i.e. greater effects on BMD at 3 [*] months, and a higher ratio of bone formation vs. resorption) compared to Forteo.