Merck announced results from a Phase 2 trial evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, as compared to the currently available 13-valent pneumococcal conjugate vaccine in healthy infants 6-12 weeks of age. In the study, designated V114-008, V114 met its primary endpoint by demonstrating noninferiority for the 13 serotypes contained in both vaccines. V114 also induced an immune response in infants for two additional disease-causing serotypes, 22F and 33F, which are not contained in PCV13. In January 2019, V114 received a Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of invasive pneumococcal disease caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. The FDA’s decision was informed in part by immunogenicity data from this Phase 2 study, V114-008, and the Phase 1/2 V114-005 study in healthy adults and infants. Results of the V114-008 study were presented during an oral session at the 37th Annual Meeting of the European Society for Paediatric Infectious Diseases and reinforce continued progression of Phase 3 clinical studies with V114. V114-008, a double-blind, randomized, Phase 2 trial, compared the safety, tolerability, and immunogenicity of two different clinical lots of V114 to PCV13 in approximately 1,050 healthy infants at two, four, six and 12-15 months of age. In the study, the percentage of subjects who achieved the WHO-accepted threshold of immune response with either lot of V114 was noninferior to the percentage seen with PCV13 for the 13 serotypes shared between the two vaccines. For serotype 3, the percentage of subjects who achieved this threshold of immune response was higher for V114 compared with PCV13. For the two serotypes not included in PCV13, serotype 22F and serotype 33F, the percentage of subjects who achieved the defined threshold of immune response with V114 was above 98% and above 87%, respectively. Results were consistent between the two lots of V114 studied. Safety profiles were evaluated after each dose and throughout the study. In the study, the adverse event profile for V114, including the number of serious adverse events, was found to be comparable to PCV13. The percentage of subjects who reported clinical AEs and serious AEs was similar in all treatment arms. The most commonly reported adverse events were injection site reactions, the majority of which were mild to moderate in severity and of short duration.
Wednesday, May 8, 2019
Merck says Phase 2 trial of V114 in infants met primary endpoint
Merck announced results from a Phase 2 trial evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, as compared to the currently available 13-valent pneumococcal conjugate vaccine in healthy infants 6-12 weeks of age. In the study, designated V114-008, V114 met its primary endpoint by demonstrating noninferiority for the 13 serotypes contained in both vaccines. V114 also induced an immune response in infants for two additional disease-causing serotypes, 22F and 33F, which are not contained in PCV13. In January 2019, V114 received a Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of invasive pneumococcal disease caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. The FDA’s decision was informed in part by immunogenicity data from this Phase 2 study, V114-008, and the Phase 1/2 V114-005 study in healthy adults and infants. Results of the V114-008 study were presented during an oral session at the 37th Annual Meeting of the European Society for Paediatric Infectious Diseases and reinforce continued progression of Phase 3 clinical studies with V114. V114-008, a double-blind, randomized, Phase 2 trial, compared the safety, tolerability, and immunogenicity of two different clinical lots of V114 to PCV13 in approximately 1,050 healthy infants at two, four, six and 12-15 months of age. In the study, the percentage of subjects who achieved the WHO-accepted threshold of immune response with either lot of V114 was noninferior to the percentage seen with PCV13 for the 13 serotypes shared between the two vaccines. For serotype 3, the percentage of subjects who achieved this threshold of immune response was higher for V114 compared with PCV13. For the two serotypes not included in PCV13, serotype 22F and serotype 33F, the percentage of subjects who achieved the defined threshold of immune response with V114 was above 98% and above 87%, respectively. Results were consistent between the two lots of V114 studied. Safety profiles were evaluated after each dose and throughout the study. In the study, the adverse event profile for V114, including the number of serious adverse events, was found to be comparable to PCV13. The percentage of subjects who reported clinical AEs and serious AEs was similar in all treatment arms. The most commonly reported adverse events were injection site reactions, the majority of which were mild to moderate in severity and of short duration.
Henry Schein price target raised to $77 from $72 at Craig-Hallum
Craig-Hallum analyst Kevin Ellich raised his price target for Henry Schein to $77 from $72 after the company reported “solid” Q1 results and 2019 EPS guidance was raised at the upper end of the range. The analyst is encouraged by the “solid” Q1 results following the animal health spinoff in February and remains optimistic about the remainder of this year as management continues to focus on strategic growth initiatives such as shifting to higher margin products in dental and medical, as well as delivering on cost initiatives and expansion outside of the U.S. Ellich reiterates a Buy rating on the shares.
Regeneron price target lowered to $375 from $412 at BMO Capital
BMO Capital analyst Matthew lowered his price target on Regeneron (REGN) to $375 after its “uninspiring” Q1 driven by higher R&D costs and lower collaboration revenue with Sanofi (SNY). The analyst notes that while the company’s Dupixent is “showing progress” and Eylea’s 8% revenue growth is a positive, he is also concerned with higher discounting for the latter along with the potential for a more competitive vascular endothelial growth factor, or VEGF, landscape. Luchini keeps his Market Perform rating on Regeneron.
Allergan price target lowered to $140 from $165 at RBC Capital
RBC Capital analyst Randall Stanicky lowered his price target on Allergan to $140 and kept his Sector Perform rating, saying that while the company has outperformed with Q1 earnings and raised its FY19 revenue view, the management’s affirmed 5% medium-term growth forecast is “aggressive”. The analyst believes that capital deployment will likely be needed to meets Allergan’s targets and also points to the “lack of meaningful catalysts to drive upside” along with the management’s lacking appetite to “reverse recent headwinds” with strategic alternatives.
Constellation Pharmaceuticals reports Q1 EPS (75c), consensus (80c)
Cash, cash equivalents, and marketable securities as of March 31, 2019, increased 1.0% compared to December 31, 2018, to $115.8 million due to proceeds from a $20 million term loan led by Hercules Capital, which approximately offset operating expenses in the quarter. Research and development expenses increased 58.8% year over year to $15.7 million in the first quarter of 2019 mainly due to increased clinical trial expenses. “2019 is a year of data for Constellation,” said Jigar Raythatha, President and Chief Executive Officer of Constellation Pharmaceuticals. “We look forward to an exciting year ahead, as we continue to see strong enrollment trends and expect multiple clinical readouts throughout the year for both CPI-0610 in myelofibrosis and CPI-1205 in prostate cancer. “We look forward to presenting an interim update of data from the Phase 2 MANIFEST clinical trial for CPI-0610 in a poster presentation at ASCO and an oral presentation at EHA in June,” Mr. Raythatha continued. “We believe these data will support the view that CPI-0610 has the potential to be a disease-modifying agent in MF. Additionally, we expect to provide further data readouts on both CPI-0610 and CPI-1205 in the second half of 2019.
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