Phase 2b Study definition

Phase 2b Study means a controlled Phase 2 Study of a Product conducted by Licensee that is designed to determine the optimal dose for administration in a Phase 3 Study.

Phase 2b Study means a clinical study of an investigational product in patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. 312.21(b), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 2b Study shall be deemed commenced when Initiated.

Phase 2b Study means a controlled dose ranging Phase 2 Study with a sufficient number of patients to generate sufficient safety and efficacy data to, if successful, commence a Phase 3 Study.

Examples of Phase 2b Study in a sentence

• Divergent Hypoglycemic Effects of Hepatic-Directed Prandial Insulin: A 6-Month Phase 2b Study in Type 1 Diabetes.

• A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients with Inadequate Glycemic Control on Oral Therapy.

• POS0226 Bimekizumab Long-Term Safety And Efficacy In Patients With Ankylosing Spondylitis: 3-Year Results From A Phase 2b Study.

• XORTX is continuing to advance pre-clinical trial activities and progressing of the additional information requested by the FDA to obtain ODD status for XRx-008.With regard to Company access to an XOI inhibitor for the treatment of T2DN, XORTX’s LOI with Teijin provides a near term focus for the promising TMX- 049 molecule to test the safety and effectiveness of TMX-049 in a Phase 2b Study in patients with progressing kidney disease due to T2DN.

• With regard to Company access to an XOI inhibitor for the treatment of T2DN, XORTX’s LOI with Teijin provides a near term focus for the promising TMX- 049 molecule to test the safety and effectiveness of TMX-049 in a Phase 2b Study in patients with progressing kidney disease due to T2DN.

More Definitions of Phase 2b Study

Phase 2b Study means a phase 2b study carried out prior to the initiation of pivotal Phase 3 Studies that is intended to be the definitive dose range finding study in patients with efficacy as a primary endpoint, as well as safety, initiated after completion of a Phase I Clinical Study (or phase 2a Clinical Study, if performed), that will evaluate the dose-dependent effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or condition under study, as well as to collect further safety data to assess the risks associated with the pharmaceutical product, and further pharmacokinetic and pharmacodynamic data. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and shall be deemed commenced when the first patient in such study has received his or her initial dose of a product. [***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Phase 2b Study means a Phase 2 Study that is a randomized study.

Phase 2b Study means a further Phase 2 Study for a Product for the same Indication that is intended to identify the definite dose range for efficacy at the primary endpoint for that Indication.

Phase 2b Study means that certain Phase 2b clinical trial being conducted by XOMA or its Affiliates as of the Effective Date and referred to as X052078, with respect to the Product in Type 2 diabetes.

Phase 2b Study means a clinical study conducted in any country that is intended to explore the efficacy and safety of a Licensed Product or Licensed Compound; e.g., through use of a variety of doses, dose response and duration of effect, that would satisfy the requirements of 21 CFR 312.21(b), or an equivalent Clinical Study required by a Regulatory Authority in a jurisdiction outside of the United States.

Phase 2b Study means a clinical study of an investigational product in patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. 312.21(b), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 2b Study shall be deemed commenced when Initiated. Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Phase 2b Study means a dose ranging clinical trial, including, without limitation, the [...***...] Study, to evaluate further the efficacy and safety of a candidate drug in the targeted patient population and to define the optimal dosing regimen.