Azetidines

Melinta Therapeutics and Hikma Sign Exclusive Licensing Agreement for Two Novel Anti-Infectives for the Middle East and North Africa Region

Retrieved on: 
Thursday, April 29, 2021

This extends Hikma\xe2\x80\x99s existing partnership with Melinta for their intravenous and oral formulations of Baxdela\xc2\xae (delafloxacin), a novel antibiotic product.

Key Points: 
  • This extends Hikma\xe2\x80\x99s existing partnership with Melinta for their intravenous and oral formulations of Baxdela\xc2\xae (delafloxacin), a novel antibiotic product.
  • \xe2\x80\x9cAs one of the leading suppliers in the region, it is our responsibility to equip doctors with the latest and most innovative developments to treat their patients.
  • Visit www.melinta.com for more information.\nHikma helps put better health within reach every day for millions of people around the world.
  • For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them.

Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study

Retrieved on: 
Tuesday, April 20, 2021

In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo.

Key Points: 
  • In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo.
  • "\nThe BRAVE-AA trial program was designed to evaluate the efficacy and safety of baricitinib in adult patients with severe AA.
  • Based on interim results of the Phase 2 portion of BRAVE-AA1 at Week 12, baricitinib 2-mg and 4-mg once-daily doses were selected for further evaluation in the Phase 3 portion of the study.
  • BRAVE-AA2 is a multicenter, randomized, double-blind, placebo-controlled study evaluating the baricitinib 2-mg and 4-mg dosing regimens versus placebo.

BenevolentAI: Data from Eli Lilly's COV-BARRIER trial shows baricitinib reduced deaths in hospitalised COVID-19 patients by 38%

Retrieved on: 
Thursday, April 8, 2021

The COV-BARRIER results further validate BenevolentAI's AI-derived hypothesis, first published in early February 2020, which prompted additional global trials and investigations into its efficacy as a treatment for critically ill COVID-19 patients.

Key Points: 
  • The COV-BARRIER results further validate BenevolentAI's AI-derived hypothesis, first published in early February 2020, which prompted additional global trials and investigations into its efficacy as a treatment for critically ill COVID-19 patients.
  • In the COV-BARRIER study, baricitinib was given in addition to the standard of care, which included dexamethasone in the majority of patients.
  • The significant reduction in mortality demonstrated in the COV-BARRIER trial follows several published studies confirming baricitnib's therapeutic effect, such as those in EMBO Mol Med , Science Advances , J. Clin.
  • Baricitinib is approved for the treatment of rheumatoid arthritis and other diseases.

BenevolentAI: Data from Eli Lilly's COV-BARRIER trial shows baricitinib reduced deaths in hospitalised COVID-19 patients by 38%

Retrieved on: 
Thursday, April 8, 2021

The COV-BARRIER results further validate BenevolentAI's AI-derived hypothesis, first published in early February 2020, which prompted additional global trials and investigations into its efficacy as a treatment for critically ill COVID-19 patients.

Key Points: 
  • The COV-BARRIER results further validate BenevolentAI's AI-derived hypothesis, first published in early February 2020, which prompted additional global trials and investigations into its efficacy as a treatment for critically ill COVID-19 patients.
  • In the COV-BARRIER study, baricitinib was given in addition to the standard of care, which included dexamethasone in the majority of patients.
  • The significant reduction in mortality demonstrated in the COV-BARRIER trial follows several published studies confirming baricitnib's therapeutic effect, such as those in EMBO Mol Med , Science Advances , J. Clin.
  • Baricitinib is approved for the treatment of rheumatoid arthritis and other diseases.

Emmes Announces its Contribution to Second Remdesivir Clinical Trial for COVID-19

Retrieved on: 
Monday, December 14, 2020

The ACTT-2 trial assessed the efficacy and safety of a 4-mg dose of baricitinib with remdesivir, versus remdesivir alone, in hospitalized COVID-19 patients.

Key Points: 
  • The ACTT-2 trial assessed the efficacy and safety of a 4-mg dose of baricitinib with remdesivir, versus remdesivir alone, in hospitalized COVID-19 patients.
  • The trial found that baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating clinical status improvement.
  • They are Michelle Green, a vice president and Emmes' lead project manager for the trial; Dr. Mat Makowski, lead Emmes biostatistician; and Jennifer Ferreira, senior biostatistician.
  • The ACTT-1 trial was one of the studies used in support of the FDA approval of remdesivir on October 22.

FDA grants Emergency Use Authorisation for baricitinib in hospitalised COVID-19 patients nine months after initial hypothesis was published by BenevolentAI

Retrieved on: 
Friday, November 20, 2020

- The FDA authorisation enables immediate use of baricitinib in combination with remdesivir to treat hospitalised COVID-19 patients.

Key Points: 
  • - The FDA authorisation enables immediate use of baricitinib in combination with remdesivir to treat hospitalised COVID-19 patients.
  • -ACTT-2 data demonstrated baricitinib improved clinical outcomes and increased recovery rates of hospitalised COVID-19 patients.
  • The speed at which baricitinib entered clinical trials reflected the urgency of the pandemic and is testament to the strength of BenevolentAI's initial hypothesis.
  • The NIAID ACTT-2 trial data confirmed our initial hypothesis that baricitinib could be an effective treatment for hospitalised patients with COVID-19.

FDA grants Emergency Use Authorisation for baricitinib in hospitalised COVID-19 patients nine months after initial hypothesis was published by BenevolentAI

Retrieved on: 
Friday, November 20, 2020

The speed at which baricitinib entered clinical trials reflected the urgency of the pandemic and is testament to the strength of BenevolentAI's initial hypothesis.

Key Points: 
  • The speed at which baricitinib entered clinical trials reflected the urgency of the pandemic and is testament to the strength of BenevolentAI's initial hypothesis.
  • This action from the FDA for the EUA of baricitinib is an important milestone that has progressed at an unprecedented pace, moving from computer to bench to bedside in nine months.
  • The NIAID ACTT-2 trial data confirmed our initial hypothesis that baricitinib could be an effective treatment for hospitalised patients with COVID-19.
  • BenevolentAI is headquartered in London with a research facility in Cambridge (UK) and an additional office in New York.

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

Retrieved on: 
Friday, October 30, 2020

Data from the Phase 2 portion of BRAVE-AA1, an ongoing Phase 2/3 study evaluating the safety and efficacy of baricitinib in adult patients with AA will be shared.

Key Points: 
  • Data from the Phase 2 portion of BRAVE-AA1, an ongoing Phase 2/3 study evaluating the safety and efficacy of baricitinib in adult patients with AA will be shared.
  • In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1.
  • For more information about the Lilly data being presented at this year's virtual Fall Clinical Dermatology meeting, please visit https://fallclinical.health/fall-clinical-20 .
  • Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.

Revolution Medicines to Present Interim Data at ENA 2020 from Phase 1b/2 Clinical Trial Combining RMC-4630 with Cobimetinib for RAS-Addicted Solid Tumors

Retrieved on: 
Monday, October 12, 2020

Preliminary data to be presented at ENA 2020 will focus on safety, tolerability and pharmacokinetic findings from combination dosing regimens.

Key Points: 
  • Preliminary data to be presented at ENA 2020 will focus on safety, tolerability and pharmacokinetic findings from combination dosing regimens.
  • We are gratified that data from our ongoing combination trial of RMC-4630 and cobimetinib were selected for presentation at ENA 2020.
  • Drug combinations will likely be critical to defeating inherent drug resistance mechanisms exploited by RAS-addicted cancers, said Steve Kelsey, M.D., president of research and development at Revolution Medicines.
  • Revolution Medicines is a clinical-stage precision oncology company developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers.

Lilly Begins a Phase 3 Clinical Trial with Baricitinib for Hospitalized COVID-19 Patients

Retrieved on: 
Thursday, June 18, 2020

Lilly expects to enroll 400 patients in the trial, with data expected in the next few months.

Key Points: 
  • Lilly expects to enroll 400 patients in the trial, with data expected in the next few months.
  • A manuscript detailing this mechanism of action of baricitinib in COVID-19 has been accepted for publication by EMBO Molecular Medicine.
  • Lilly is also supporting select ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with COVID-19 infections, including a trial in Nova Scotia, Canada.
  • Should research efforts for baricitinib in COVID-19 prove successful, Lilly will continue to create adequate supply to support both appropriate clinical and investigational use.