Update for February 17, 2023
New Drugs Added to Knowledgebase
We recently added six new drugs to the knowledgebase:
The FDA rejected the NDA for SGX301 for the treatment of early-stage cutaneous T-cell lymphoma and requested additional information.
The FDA designated rexlemestrocel-L, a Regenerative Medicine Advanced Therapy (RMAT) for in the treatment of chronic low back pain associated with disc degeneration, in combination with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc.
Announced Research Updates
Galapagos announced that in the 58-week, 1,374 patient, Phase III, DIVERSITY trial, treatment with filgotinib did not induce remission at 10-weeks compared to placebo in patients with moderate to severe Crohn's disease. In the maintenance phase, remission at 58 weeks was achieved by 43.8% of patients treated with filgotinib 200 mg and 26.4% with placebo. 30.4% of filgotinib 200 mg patients had an endoscopic response compared to 9.4% with placebo during the maintenance phase.
G1 Therapeutics announced that in the 326 patient, Phase III, PRESERVE 1 trial, adding trilaciclib to FOLFOXIRI plus bevacizumab decreased the occurrence of severe neutropenia (1% vs 20%) and duration of severe neutropenia (0.1 day vs 1.3 days) compared to placebo in patients with metastatic colorectal cancer. However the overall response rate (ORR) was higher with placebo (61% and 50%). GI Therapeutics discontinued the PRESERVE 1 trial after the overall response rate was found to be higher with trilaciclib compared to placebo.
AlloVir announced that in a 24-week, 52 patient, Phase II trial, treatment with posoleucel resulted in greater BK viral load reduction than placebo in kidney transplant patients with BK viremia.
Applied Therapeutics announced 90-day interim data from the 50 patient, Phase III, INSPIRE trial, where treatment with gavorestat reduced sorbitol levels 52% compared to placebo in patients with Sorbitol Dehydrogenase (SORD) Deficiency.
Published Research Updates
In a 12-week, 229 patient, Phase II trial, the increase in left ventricular ejection fraction (LVEF) was similar for firibastat 100 mg (5.3%), firibastat 200 mg (5.3%) and ramipril 5 mg (5.7%) in post anterior myocardial infarction patients.
In the 24-week, 263 patient, open-label, Phase III, ECOSPOR IV trial, 8.7% of patients treated with SER-109 experienced a recurrence of C. difficile infection at eight weeks in patients with recurrent C. difficile infection. After 24 weeks 86.3% of patients treated maintained a sustained clinical response.
In a 24-week, 366-patient Phase IIb trial, adding OPT-302 2 mg to ranibizumab resulted in a 14.2 letter improvement in Best Corrected Visual Acuity (BCVA) compared to an 10.8 letter improvement with ranibizumab monotherapy in patients with wet age-related macular degeneration (AMD). There was no improvement in BCVA with the 0.5 mg dose.
In the 5,782 patient, Phase IIb, CYPRESS trial, J&J’s RSV vaccine achieved vaccine efficacy of 80% to prevent three or more symptoms of lower respiratory tract infection, 75% to prevent two or more symptoms of lower respiratory tract infection and 69.8% to prevent either two or more symptoms of lower respiratory tract infection or one or more symptoms of lower respiratory tract infection plus at least one systemic symptom in patients 65 years and older.
In the 28-day, 1,951 patient, Phase III TOGETHER trial (NCT04727424), 2.7% of patients treated with peginterferon lambda were hospitalized or had an ER visit compared to 5.6% with placebo in non-hospitalized adult Brazilian patients with COVID-19. 83% of the patients had received at least one COVID-19 vaccination.
Update for February 8, 2023
The FDA approved daprodustat (Jesduvroq, GSK), on 2/1/2023, to treat anemia in chronic kidney disease patients on dialysis. Daprodustat was approved with a boxed warning of the increased risk of increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
The FDA accepted the NDA for zuranolone for the treatment of major depressive disorder and postpartum depression and set a PDUFA date for 8/5/2023.
Mesoblast resubmitted a BLA for remestemcel-L to treat pediatric steroid-refractory acute graft versus host disease.
Roche discontinued development of ipatasertib and gantenerumab due to lack of efficacy.
In February 2023, Vistagen proposed changes to the PALISADE-2 study protocol to the FDA. Vistagen is also designing a new Phase III trial that would include multiple doses of PH94B and use the the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint. The outcome of a meeting with the FDA will determine when the PALISADE-2 trial would be restarted.
Announced Research Updates
Roche announced that in the 25-week, 200 patient, open-label, Phase III COMMODORE 2 trial, treatment with crovalimab was non-inferior to eculizumab in achievement of an LDH of 1.5 or less of the upper limit of normal and being RBC transfusion free in non-U.S. patients with PNH who have not been previously treated with complement inhibitors.
Published Research Updates
In a 96-week, 453 patient, Phase II trial, treatment with tilavonemab did not improve the Clinical Dementia Rating-Sum of Boxes score compared to placebo in patients with early Alzheimer's disease.
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