Entasis Therapeutics announced the initiation of the ATTACK Phase 3 pivotal clinical trial to evaluate ETX2514SUL, a fixed-dose combination of its broad-spectrum ss-lactamase inhibitor ETX2514 with sulbactam, for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii. A. baumannii is a Gram-negative bacterium that causes severe infections and is associated with high mortality, increasing rates of antibiotic resistance and growing significance as a hospital-acquired infection due to limited treatment options. Outbreaks of A. baumannii typically occur in intensive care units and healthcare settings with seriously ill patients and can either cause or contribute to death.
https://thefly.com/landingPageNews.php?id=2888537
Thursday, April 4, 2019
Perrigo Gets Tentative FDA Approval For Generic Version Of Sernivo® Spray
Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of “Quality, Affordable, Self-Care Products™“, today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Sernivo® (betamethasone dipropionate) Spray 0.05%. Perrigo previously settled its Hatch-Waxman litigation relating to Sernivo® (betamethasone dipropionate) Spray 0.05% brought by Promius Pharma LLC. Terms of the settlement remain confidential.
Annual market sales for the 12 months ending February 2019 were approximately $15 million as measured by IQVIA™.
Twist Bioscience, LakePharma to collaborate for antibody discovery
Twist Bioscience Corporation and LakePharma announced a strategic collaboration to offer antibody discovery and development solutions to pharmaceutical and biotechnology customers. Under the terms of the agreement, LakePharma will have the ability to offer Twist’s proprietary antibody discovery and optimization platforms to their existing and future biopharmaceutical customers as part of their service offerings. One such platform generated is for discovery of novel therapeutic antibodies against a major class of protein drug targets known as GPCRs, which traditionally have been difficult for biologics drug development. GPCRs have been heavily investigated due to their involvement in multiple disease classes, including inflammation, cancer, metabolism, respiratory, and pain. In return, customers of Twist will have access to LakePharma’s integrated discovery and development services.
https://thefly.com/landingPageNews.php?id=2888539
https://thefly.com/landingPageNews.php?id=2888539
Brain Scans Spot, Track Alzheimer’s
Brain scans can improve diagnosis and management of Alzheimer’s disease, a new study claims.
Researchers assessed the use of PET scans to identify Alzheimer’s-related amyloid plaques in the brain. The study included more than 11,000 Medicare beneficiaries with mild thinking impairment or dementia of uncertain cause.
This scanning technique changed the diagnosis of the cause of mental impairment in more than one-third of the participants in the study.
The brain scan results also changed management — including the use of medications and counseling — in nearly two-thirds of cases, according to the study published April 2 in the Journal of the American Medical Association.
“These results present highly credible, large-scale evidence that amyloid PET imaging can be a powerful tool to improve the accuracy of Alzheimer’s diagnosis and lead to better medical management, especially in difficult-to-diagnose cases,” said study co-author Maria Carrillo, chief science officer of the Alzheimer’s Association.
“It is important that amyloid PET imaging be more broadly accessible to those who need it,” she added in an association news release.
Funding for the study came from Avid Radiopharmaceuticals Inc., General Electric Healthcare, and Life Molecular Imaging.
“We are impressed by the magnitude of these results, which make it clear that amyloid PET imaging can have a major impact on how we diagnose and care for patients with Alzheimer’s disease and other forms of cognitive decline,” said lead author Dr. Gil Rabinovici. He’s a professor of neurology at the Memory and Aging Center at the University of California, San Francisco.
There is no cure for Alzheimer’s disease, but early diagnosis means that patients can receive treatment to manage symptoms and be directed to clinical trials for new drugs.
Early diagnosis also means that patients and families can plan for the future, including safety, care, legal and financial issues, and access resources and support programs, the researchers said.
In this study, the PET scans revealed that about one-third of patients previously diagnosed with Alzheimer’s had no significant amyloid buildup, and their Alzheimer’s diagnosis was reversed.
But in nearly half of patients not previously diagnosed with Alzheimer’s, the PET scans revealed significant amyloid plaque buildup, resulting in a new diagnosis of Alzheimer’s.
One-third of the study participants who had previously been referred to Alzheimer’s clinical trials showed no sign of amyloid buildup based on PET scans. Based on those results, doctors were able to ensure that nearly all (93 percent) of patients referred to Alzheimer’s trials were amyloid-positive, which is critical to these trials’ success.
“Accurate diagnoses are critical to ensure patients are receiving the most appropriate treatments. In particular, Alzheimer’s medications can worsen cognitive decline in people with other brain diseases,” Rabinovici said.
“But perhaps more fundamentally, people who come into the clinic with concerns about memory problems want answers. An early, definitive diagnosis may allow individuals to be part of planning for the next phase of their lives and to make decisions that otherwise would eventually need to be made by others,” he said.
More information
The U.S. National Institute on Aging has more about Alzheimer’s disease.
SOURCE: Alzheimer’s Association, news release, April 2, 2019
EMA tells Aveo it wants to see something better on tivo this summer
When Aveo Oncology scored European approval in 2017 for its lead cancer drug tivozanib — despite the treatment’s chequered past — a comeback story was in the making. New pivotal data could now threaten that approval, and the company’s investors are losing patience.
In 2013, data from the 517-patient TIVO-1 study testing tivozanib against sorafenib in frontline patients with advanced renal cell carcinoma (RCC) showed patients given the Aveo drug did not live as long as those on sorafenib (median OS of 28.8 months for tivozanib versus 29.3 months for sorafenib) — although the difference in overall survival was not statistically significant (HR=1.245, p=0.105). However, tivozanib did meet the main goal of significantly improving progression-free survival (PFS) by a median of 2.8 months (HR=0.797; P=0.042).
The FDA was not impressed. The agency’s cancer czar Richard Pazdur issued a scathing review of tivozanib, asserting that an approval for a drug that could be tied to an increased risk of death would set a dangerous precedent. An outright rejection followed.
In 2016, Aveo’s fresh faced management agreed to fork over $4 million to settle SEC charges that were imposed on the drug developer’s former top executive team — which stepped down the preceding year — for keeping secret the FDA’s demand for a new tivozanib study, to answer lingering concerns over patient deaths in TIVO-1, in order to qualify for approval.
Meanwhile, the EMA was a little more generous. In 2017, the EU sanctioned Aveo’s partner EUSA Pharma approval for tivozanib — but with a caveat that topline data results from the 351-patient TIVO-3 trial — evaluating tivozanib against sorafenib in RCC who have failed at least two prior regimens — would be provided as part of post-marketing requirements.
Much like TIVO-1, data from TIVO-3 unveiled last November showed tivozanib induced a statistically significant improvement in PFS (Median PFS was 5.6 months for tivozanib compared to 3.9 months for sorafenib; HR=0.74; p=0.02). Months later, Aveo provided preliminary OS data that suggested a non-statistically significant difference in OS favoring sorafenib (HR=1.12, p=0.44).
On Wednesday, Aveo in a filing said the EMA has asked for the additional interim OS analysis of TIVO-3 by August 2019, and that “regulatory action” will be considered if a negative OS trend is confirmed. In effect, if this OS trend is cemented with mature data by August, Aveo could see its EU approval rescinded.
AstraZeneca: Positive results from Fasenra Phase 2 trial published
A Phase II trial has demonstrated that Fasenra (benralizumab) can achieve near-complete depletion of eosinophils and improve clinical outcomes in hypereosinophilic syndrome (HES). The results are published in the New England Journal of Medicine.
In the randomised phase of the 20-patient trial, the primary efficacy endpoint was the percentage of patients who reduced their absolute blood eosinophil counts by 50% or more at week 12.1 This was achieved by 90% of patients treated with Fasenracompared with 30% of patients treated with placebo, a statistically significant difference.
In the open-label phase of the trial, 74% of patients maintained a reduction in eosinophil counts and had clinical improvements in their symptoms through week 48.1 Of these patients, 64% were able to taper background HES medications. In patients from whom tissue biopsies were obtained (gastrointestinal tract and skin) there was near-complete depletion of eosinophils following treatment with Fasenra.
Mene Pangalos, Executive Vice President and President BioPharmaceuticals R&D, said: ‘We are encouraged by these trial results for Fasenra in hypereosinophilic syndrome and the data are potentially important given the limited treatment options for this debilitating disease.’
HES is a group of rare, potentially fatal disorders characterised by high numbers of eosinophils in blood and tissues which can cause progressive, potentially life-threatening organ damage.2,3 At the start of the Phase II trial, patients had significantly elevated levels of blood eosinophils ranging from 1,000 to 21,580 cells per μl.1
During the 48-week treatment period, the three most frequently reported adverse events attributed to Fasenra included headache, elevated lactate dehydrogenase (LDH) concentration and chills.1 The observed increases in LDH occurred after the first dose of Fasenra and resolved within 48 hours. The trial was a collaboration between AstraZeneca and the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health.
Fasenra is currently approved as an add-on maintenance treatment for severe, eosinophilic asthma in the US, EU, Japan and other countries. The US Food and Drug Administration (FDA) granted Orphan Drug Designation for Fasenra for the treatment of HES in February 2019.
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