Danish biotech firm starts human trials for new Covid drug

The Danish biotech company Union Therapeutics has been given the go-ahead to begin clinical trials on humans for its coronavirus medicine which early studies show is more than 40 times more effective than Remdesivir.

Danish biotech firm starts human trials for new Covid drug
Niclosamide is one of hundreds of promising new drugs. Sorrento Therapeutics in San Diego, California, is working on an antibody drug. Reuters/Scanpix/Bing Guan
Dr Rasmus Toft-Kehler, chief executive and co-founder of the company, credited the “amazing period” that saw the medicine rushed through preliminary trials. 
“The team, including all stakeholders, partners… and not least regulatory authorities, have acted with passion and in concert to advance UNI911 at an incredible pace,” he said in a press statement.
“We are honoured to be part of this venture and excited to be at the cusp of initiating clinical studies with the ultimate goal of making a differentiated product available for patients in need”.
The drug UNI911, or niclosamide, will be tested at the Zelo Phase I Unit at Bispebjerg and Frederiksberg Hopsital and at the Center for Physical Activity Research at Rigshospitalet. 
“It is a drug that can kill the virus and prevent it from dividing inside the body,” Morten Sommer, a professor at DTU Biosustain and the co-founder of Union, told TV2
“Previously, it has been used to treat bowel diseases such as tapeworms, but we have found out how the drug can come out and work elsewhere in the body.” 
In studies from South Korea, niclosamide has proven 40 times more potent than the drug Remdesivir, which has otherwise been considered the most effective drug for treating Covid-19.
Sommer expects the development of the drug to move into the second phase this autumn. 
“It is still early in the process, but we think the characteristic we have seen of the drug seem really promising, and if the results continue to come in, we hope that it has great opportunity to contribute to the treatment of both Covid-19 and also other similar diseases.” 

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14,000 pregnant women in France took ‘birth defect drug’

According to a study released by health authorities on Wednesday, a total of 14,322 pregnant women in France took a medicine between 2007 and 2014 which has been linked to birth defects.

14,000 pregnant women in France took 'birth defect drug'
Dépakine has been linked to an increased risk of various congenital defects. File photo: AFP

Valproate, the active substance in anti-convulsion drug Dépakine, prescribed in France for epilepsy and bipolar disorder, has been linked to heart, kidney and spine defects as well as autism and developmental delays. Authorities have been sharply criticized for their slow reaction in preventing pregnant women from taking the drug.

In total, 8701 children were born to women taking the drug over the seven-year period, the study published on Wednesday said, accounting for two in every 1000 pregnancies in France over the period.

This is despite the fact that since 2006, the leaflet enclosed with the drug advised against taking it during pregnancy; this warning was added to the outer box in 2014. It wasn't until 2014 that a European report urged all countries on the continent to review their conditions for prescribing valproate “to minimize risks”.

A compensation scheme will be established for those affected, Health Minister Marisol Touraine said on Wednesday.  Parliament will vote on the scheme later in the year. Touraine also pledged that in the next six months, further measures would be put in place to support the patients “completely”.

The study, published by ANSM (French National Agency for Medicines and Health Products Safety), did not give a figure for how many of the babies suffered from birth defects due to the exposure to the drug.

However, previous studies on the effects of valproate have shown that babies born to mothers who have taken the substance have a ten percent risk of suffering from heart, kidney or spine defects, and a 30-40 percent risk of being affected by delayed development or autism.

A report released in February by France's social affairs inspectorate (IGAS) estimated that around 450 French babies had been born with congenital defects after being exposed to valproate in utero. The inspectorate arrived at this number by extrapolating data obtained in the Rhone-Alpes region, it said.

Then, IGAS criticized “the lack of reactivity” from ANSM and Sanofi, the pharmaceutical company which has produced the drug in France since 1967. In 2008, two years after the drug was officially not recommended to be taken during pregnancy, an IGAS study showed that one in five doctors and one in three pharmacists were still unaware of the effects of valproate on unborn children.

“This is a huge health scandal that could have affected between 50,000 and 70,000 people over 50 years of prescription,” said Marine Martin, president of Apesac, an organization set up to assist parents affected by Dépakine, cited by Ouest-France. According to Apesac's figures, 2426 babies have been affected by the drug, of whom 401 have died.