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Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of November 28, 2016

AstraZeneca released results of a phase III study of Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 in pediatric patients between 6 to <12 years of age with asthma. The global, multicenter, 12-week, randomized, double-blind, parallel-group CHASE 3 trial evaluated the efficacy and safety of budesonide/formoterol in a pressurized metered dose inhaler (pMDI) 80/2.25 micrograms, and Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol pMDI 80/4.5 micrograms, compared with budesonide pMDI 80 micrograms, all given two inhalations twice-daily. The study randomized 279 children 6 to <12 years of age, from which 273 received treatment, and involved a total of 88 study centers located in four countries. The study results showed changes from baseline at week 12 in one-hour post-dose FEV1 and 15-minute post-dose FEV1 were significantly greater with Symbicort 80/4.5 micrograms two inhalations twice daily versus budesonide 80 micrograms two inhalations twice daily (both p=0.015), but not budesonide/formoterol 80/2.25 micrograms two inhalations twice daily versus budesonide 80 micrograms two inhalations twice daily. The change from baseline in one-hour post-dose PEF (peak expiratory flow) was superior at week 12 with Symbicort 80/4.5 micrograms versus other treatments (p<0.05). There were no notable differences in safety profiles between either of the budesonide/formoterol doses and budesonide or between the two budesonide/formoterol doses. Among the most common adverse events, upper respiratory tract infection, pharyngitis, headache and vomiting were more frequent, with budesonide/formoterol doses compared to the budesonide 80 micrograms dose. The CHASE 3 results were submitted to the FDA and other health authorities in accordance with regulatory requirements.

Eli Lilly and Incyte issued results of two phase III trials, RA-BUILD and RA-BEAM, of baricitinib for rheumatoid arthritis (RA). The RA-BUILD study enrolled 684 patients with moderate to severe RA who previously had an inadequate response to, or were intolerant of, at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and had not received a biologic disease-modifying antirheumatic drug (bDMARD). Patients received either once-daily baricitinib (2mg or 4mg) or placebo, in addition to their background therapy. The 52-week RA-BEAM study randomized 1,307 patients who had active, moderate to severe RA, despite ongoing treatment with methotrexate. Patients were randomized to once-daily placebo (n=488), once-daily baricitinib 4mg (n=487) or biweekly adalimumab 40mg (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group. Results from a post-hoc analysis of the RA-BUILD and RA-BEAM studies evaluating elderly patients found that age did not affect baricitinib's efficacy as measured by ACR20, Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) and Simplified Disease Activity Index (SDAI). At week 12, in the baricitinib 4mg group, 67% of patients younger than 65 years and 68% of patients 65 years or older achieved an ACR20 response, meaning a 20% improvement across various aspects of RA. In the group that received placebo, 40% of patients younger than 65 years and 43% of patients 65 years or older achieved an ACR20 response. Proportion of patients in the low, middle and high BMI groups who achieved an ACR20 response were 68.4%, 68% and 64.7%, respectively. ACR50 and ACR70 responses (meaning a 50% and 70% improvement across various aspects of RA, respectively) were also improved compared to placebo across the BMI groups.

Ocular Therapeutix reported results of a phase III trial of Dextenza (dexamethasone insert) 0.4mg for the treatment of post-surgical ocular inflammation and pain. This prospective, multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled study enrolled 438 patients who were undergoing clear corneal cataract surgery at 21 sites throughout the U.S. The trial successfully met its two primary efficacy endpoints for inflammation and pain, achieving statistically significant differences between the treatment group and the placebo group for the absence of inflammatory cells on day 14 and the absence of pain on day eight, respectively. Fifty-two point three percent of patients treated with Dextenza showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14, compared to 31.1% of those receiving the placebo vehicle control punctum plug (p<0.0001). Seventy-nine point six percent of patients treated with Dextenza reported absence of pain in the study eye on day eight, compared to 61.3% of those receiving the placebo vehicle control punctum plug (p<0.0001). Ocular Therapeutix has submitted an NDA to the FDA. 

RedHill Biopharma reported results of a phase III trial of RHB-105 for H. pylori infection. The study demonstrated an overall success rate of 89.4% in eradicating H. pylori, and met its protocol-defined primary endpoint of superiority in eradication of H. pylori infection over historical standard-of-care (SoC) efficacy levels of 70%, with high statistical significance (p<0.001). Subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study demonstrated only 63% eradication rate, further supporting the potential superior efficacy of RHB-105 over SoC. A confirmatory phase III study is planned to be initiated in the U.S. Additional studies may be required, subject to FDA feedback. RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast Track development pathway, as well as NDA Priority Review status, potentially leading to a shorter NDA review time by the FDA, if filed.

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