Aslan Pharmaceuticals enters into a strategic collaboration with IQVIA
ASLAN Pharmaceuticals announced the appointment of IQVIA Biotech, a provider of analytics, technology solutions, and clinical research services to the life sciences industry, as its preferred clinical research organisation for logistics related to decentralised clinical trials, comprising the global oversight, expansion and engagement of patients for trials associated with the clinical development of ASLAN004 and ASLAN003.
IQVIA Biotech will proffer patient recruitment, clinical monitoring, medical writing and biostatistics for ASLAN’s upcoming 300-patient Phase 2b trial of ASLAN004 in adults with moderate-to-severe atopic dermatitis. IQVIA Biotech will work closely with ASLAN’s management to supervise clinical operations and recruit patients across sites in the United States, Canada, Europe and Asia. IQVIA Biotech is also positioned to partner with ASLAN’s clinical operations team on the future development plans for ASLAN003 in inflammatory bowel disease (IBD), with clinical trials starting early next year. Enrollment of the first patient in the ASLAN004 Phase 2b trial is anticipated in the fourth quarter of 2021.
Senthil Sockalingam, Head, IQVIA Biotech Japan and the Asia Pacific, said they are happy to partner with ASLAN on the clinical development of ASLAN003 and ASLAN004, following the successful proof-of-concept study for ASLAN004 in atopic dermatitis. Upcoming biopharma companies display a considerable portion of innovation in life sciences, and their needs are nuanced. IQVIA Biotech is zeroed in on solutions for emerging biopharma. With the launch of IQVIA Biotech JAPAC (Japan and the Asia Pacific), they will look forward to offering ASLAN with a top-tier team for delivering on its clinical milestones.
FDA slams Reata’s kidney drug as ineffective ahead of an advisory committee meeting
The FDA offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to decrease the loss of kidney function in those with the rare disease Alport syndrome, as per briefing documents released ahead of an advisory committee meeting.
The agency’s review team said that they do not believe the submitted data show that bardoxolone effectively decreases the loss of kidney function in Alport syndrome patients and decreases the risk of advancing to kidney failure. It was initially developed as a cancer drug; bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug because of deaths in a Phase III trial.
Reata ran another Phase III trial on which this application is based. Still, the agency again raised concerns and commented that there was no data in the application from an animal model of Alport syndrome or other adequate and well-controlled clinical trials in Alport syndrome or chronic kidney disease that demonstrate that bardoxolone decreases the loss of kidney function.
In discussing some of the technical details of its efficacy analysis, the agency elaborated the loss of statistical significance based on a change in a single factor in the analytic model raised concerns regarding the robustness of the study’s findings.
Viagra is a promising drug for the prevention and treatment of Alzheimer’s Disease
Viagra could be useful for Alzheimer’s disease treatment as per a US study.
Alzheimer’s disease, the most common form of age-related dementia, affects hundreds of millions worldwide. However, despite mounting numbers of cases, there is currently no effective treatment.
Using a sizeable gene-mapping network, researchers at the Cleveland Clinic integrated genetic and other data to determine which of more than 1,600 Food and Drug Administration-approved drugs could be an effective treatment for Alzheimer’s disease. They gave higher scores to drugs targeting both amyloid and tau – two hallmarks of Alzheimer’s – compared with drugs that targeted just one or the other.
Dr Feixiong Cheng, the study lead, said that Sildenafil had been shown to tremendously enhance cognition and memory in preclinical models, presented as the best drug candidate. Viagra is the brand name of sildenafil.
Researchers then utilised a database of claims from more than 7 million people in the US to assess the relationship between sildenafil and Alzheimer’s disease results by comparing sildenafil users to non-users.
They observed sildenafil users were 69% less likely to develop Alzheimer’s disease than non-sildenafil users after six years of follow-up. To further discover the drug’s potential effect on Alzheimer’s disease, researchers developed a lab model that showed that sildenafil increased brain cell growth and targeted tau proteins, proffering data into how it might influence disease-related brain changes. The findings were published in Nature Aging.
Recordati to acquire EUSA Pharma for USD 847 Million to expand Rare Disease offerings
An Italian pharma company engineered a nearly USD 850 million buyout last week, seeking to extend its rare disease portfolio and further soak up parts of the US market. Still, questions continue over the drugs involved and when they could see patient uptake stateside.
Recordati spent the cash buying EUSA Pharma and its portfolio of four rare disease drugs, the companies announced, allowing Recordati to position itself for growth in the US. EUSA’s top candidate for expansion is ostensibly the neuroblastoma drug Qarziba, approved in the EU for high-risk, newly-diagnosed individuals.
During an investor call, Recordati executives touted a US approval for Qarziba as a possible key value driver in this agreement. But when a Credit Suisse analyst pointed out EUSA previously stated in press releases it anticipated to file Qarziba’s US approval in 2017, an OK still had not come through, and there did not appear to be any ongoing clinical trials, the company had few answers for when it would approach the FDA.
Chairman Andrea Recordati essentially raised, saying he could not give any definitive timelines because the deal is not anticipated to close until next year.
Recordati said they are still in between the signing and closing handling situations, so they require to discuss this, closing EUSA, and it is not appropriate to give them more details at this stage.
He went on to say while Qarziba is expected to be a vital part of the company’s plans, Recordati is also looking at the rare lymph node disorder drug Sylvant as another growth driver, currently approved in the US and EU.