News

A Phase 3 trial designed to generate a new cancer indication for Venclexta (venetoclax) failed to meet its primary endpoint of a statistically significant improvement in overall survival in acute myeloid leukaemia, AbbVie Inc announced on 28 February. Venclexta is being jointly developed with Roche and already has been approved in four cancer indications. The newest trial compared Venclexta in combination with the chemotherapy cytarabine against a combination of cytarabine and placebo. Patients in the trial had AML and were ineligible for intensive chemotherapy.

Gilead Sciences Inc has launched two Phase 3 studies of an experimental nucleotide analog to treat adults diagnosed with infection from the COVID-19 coronavirus. The studies will assess two dosing durations of the drug remdesivir, administered intravenously. They follow the US Food and Drug Administration decision to accept Gilead’s clinical trial application.

Remdesivir has been tested in humans with Ebola virus disease and in animal models for Middle East respiratory syndrome and severe acute respiratory syndrome, which are caused by other coronaviruses.

Public health and border control officials at the European Commission currently believe that the risk of imminent transmission of the COVID-19 coronavirus across the EU is low to moderate – even as the virus continues to infect increasing numbers of people in Italy.

According to the BBC, the number of cases in Italy reached 400 on 26 February, up by 25% in just 24 hours. To date, there have been 12 fatalities.

Bicycle Therapeutics Plc has entered into a collaboration with Genentech, a member of the Roche Group, to develop new therapies for cancer using its short peptide technology. The deal is potentially valued at up to $1.7 billion, giving the 11-year old company significant new resources to develop its technology. The company’s scientific founders are Gregory Winter, who invented a technique for humanising mouse monoclonal antibodies, and Christian Heinis, a researcher in the field of peptide therapeutics.

The Type 2 diabetes medicine Trulicity (dulaglutide) has been approved in the US to treat adults with diabetes who have cardiovascular disease or are at risk of the disease. The makes Trulicity, first approved in 2014, the only Type 2 diabetes medicine that can also be used to reduce the risk of major adverse cardiovascular events.

Positive long-term data have been reported for a cell therapy being tested in patients with retinitis pigmentosa, a group of hereditary diseases of the eye that can lead to a progressive loss of vision and blindness. Results from the ongoing US Phase 1/2a study of the human retinal progenitor cell therapy showed a meaningful clinical effect at all points in time out to 12 months after treatment.

The mode of action of an experimental treatment for septic shock has been confirmed in a Phase 2 study, paving the way for further development of the therapy in patients with an early stage of the disease. Septic shock is a life-threatening organ dysfunction caused by the body’s response to infection. The trial, AdrenOSS-2, enrolled 301 patients who were identified by a novel biomarker as having early septic shock and elevated blood levels of the peptide hormone adrenomedullin. They were treated with the monoclonal antibody adrecizumab.

The US Food and Drug Administration has stepped up its oversight of certain pharmacogenetic tests that make claims for treatments that are not supported by sound science. In an announcement on 20 February, the agency said that it was introducing a new table on the internet giving a list of gene-drug interactions that are based on scientific evidence. This can be viewed at https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations.

A new intravenous treatment for the prevention of migraine has been approved by the US Food and Drug Administration on the basis of trial data showing that patients had a sustained reduction in their disease episodes for a period of months after receiving the drug. The treatment, Vyepti (eptinezumab), is a monoclonal antibody that binds to the human calcitonin gene-related peptide with the result that migraine attacks are reduced. It was developed by Alder BioPharmaceuticals Inc, a company that was acquired by H. Lundbeck A/S of Denmark in 2019.

Galapagos ended 2019 with cash and cash equivalents of €5.8 billion, a lucrative research and development partnership with Gilead Sciences Inc, and regulatory applications in three regions for the approval of its wholly-owned product, filgotinib for rheumatoid arthritis. The company’s founder and chief executive Onno van de Stolpe said the confluence of events had ensured the company’s independence for a period of 10 years while giving it an opportunity to significantly increase the size of its portfolio.