February’s top news stories

6th March 2018 (Last Updated March 6th, 2018 00:00)

Researchers at Johns Hopkins Bloomberg School of Public Health have revealed that the number of clinical trials being funded by the National Institutes of Health (NIH) has reduced since 2005, and Novartis has received funding from the Bill & Melinda Gates Foundation to help advance drug candidate KDU731 for the treatment of cryptosporidiosis, an infectious diarrheal disease. Drugdevelopment-technology.com wraps up the key headlines from February 2018.

New study shows decreased NIH funding for drug trials

Researchers at Johns Hopkins Bloomberg School of Public Health in the US have revealed that the number of clinical trials being funded by the National Institutes of Health (NIH) has reduced since 2005.

The average size of the trials performed during 2005 to 2015 has also been reduced, with only 10% of trials enrolling more than 500 subjects.

This trend is feared to threaten an important aspect of NIH’s core mission of conducting clinical trials that involve human participants.


Novartis teams with Gates Foundation on cryptosporidiosis drug candidate

Pharmaceutical company Novartis has received funding from the Bill & Melinda Gates Foundation to help advance drug candidate KDU731 for the treatment of cryptosporidiosis, an infectious diarrheal disease.

Diarrheal diseases are one of the leading causes of global childhood mortality, causing approximately 525,000 deaths per year. Cryptosporidiosis is the second leading cause of infectious diarrhoea in children below the age of two.

KDU731 is a cryptosporidium lipid kinase PI(4)K inhibitor, shown to effectively treat cryptosporidium infection in preclinical models. Currently it is undergoing safety studies before clinical trials can begin.


Merck and Pfizer’s Phase III lung cancer trial of avelumab fails

Merck KGaA and Pfizer have failed to meet the intended endpoint in a Phase III trial of avelumab in comparison with docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with a platinum-containing doublet therapy.

The JAVELIN Lung 200 trial’s prespecified endpoint was to improve overall survival (OS) in patients with programmed death ligand-1-positive (PD-L1+) (1% or higher) tumours.

The proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, and this could have confused the outcome of the trial, noted both companies.


Aeras reports positive Phase II results in trial of BCG combination

Aeras has announced encouraging findings from its Phase II trial that examined Bacille Calmette-Guerin (BCG) revaccination in combination with H4:IC31 vaccination for treatment of tuberculosis (TB).

The trial was designed to examine BCG and H4:IC31 for safety, immunogenicity and their ability to prevent initial and sustained TB infections among healthy adolescents.

A total of 990 HIV-negative, healthy adolescents aged between 12 and 17 years who had been vaccinated as infants with BCG were enrolled for the randomised, placebo-controlled prevention-of-infection trial.


ViiV initiates Phase III study of TIVICAY and EPIVIR for HIV-1

ViiV Healthcare has started a Phase III study to examine a two-drug regimen (2DR) of dolutegravir (TIVICAY) and lamivudine (EPIVIR) for treating patients with HIV-1 who have achieved viral suppression on a tenofovir alafenamide fumarate (TAF) based regimen.

The TANGO trial aims to enrol around 550 adults with HIV-1 from clinical trial sites in North America, Europe, Australia, and Japan.

Under the trial, the subjects will be randomised 1:1 to switch to dolutegravir and lamivudine once-daily for up to 96 weeks, or to continue their TAF-based regimen for 48 weeks.


AbbVie teams with Voyager to develop Alzheimer’s gene therapy

Biopharmaceutical company AbbVie has announced a partnership with Voyager Therapeutics that will seek to develop a new single gene therapy for neurodegenerative conditions such as Alzheimer’s disease.

The announcement comes after a series of failed Alzheimer’s clinical trials. However, gene therapies, in which healthy genes are inserted into a patient’s cells to replace impaired or missing ones, offer a possible new route for treatment.

The collaboration between Voyager and AbbVie will seek to produce therapeutic antibodies that will be inserted into a patient’s cells using a benign virus. These will target clumps of the protein tau, which has been linked to Alzheimer’s disease.


Centrexion begins Phase lll trial of CNTX-4975

Centrexion Therapeutics has begun VICTORY-1, a Phase III clinical trial of CNTX-4975 for the treatment of chronic moderate-to-severe pain due to knee osteoarthritis (OA).

CNTX-4975 is a new non-opioid therapy that can be injected directly into a painful joint. It is claimed to provide fast-acting and long-lasting pain relief without the risk of abuse and addiction.

The randomised, double-blind, placebo-controlled, 52-week VICTORY-1 trial will examine the safety and efficacy of a single injection of CNTX-4975 in patients with chronic moderate-to-severe OA knee pain.


Medicines Company completes enrolment in Phase III trial of inclisiran

US-based Medicines Company has completed enrolling patients in a Phase III trial of inclisiran for treatment of heterozygous familial hypercholesterolemia patients.

Enrolment of 400 patients in the ORION-9 trial has been completed ahead of schedule.

ORION-9 is a double-blind, randomised multi-national trial, which aims to confirm the effectiveness and safety of inclisiran in heterozygous familial hypercholesterolemia patients with elevated LDL-C levels above 100mg/dL despite maximum tolerated doses of LDL-C lowering therapies, including statins.


Study claims Brexit could exclude children from clinical trials

A study from Brexit Health Alliance has suggested that children could miss out on being involved in life-saving clinical trials as a result of the UK leaving the EU.

In the absence of a right deal, the UK might not be able to fully participate in collaborative trials and research activities such as the ones that include children and adults with rare and complex diseases.

The UK could also be restricted from having access to crucial EU infrastructure that carries out the legislation authorising and managing clinical trials, posing ‘serious implications’ for patient access to medical research, said the study.


Palatin begins dosing patient in Phase l study of PL-8177

Palatin Technologies has started dosing patients in its Phase l clinical trial to assess the safety and tolerability of PL-8177 for the treatment of ulcerative colitis and other inflammatory bowel diseases.

Ulcerative colitis is a chronic disease of the large intestine, with inflammation and ulcerations that can cause symptoms such as significant abdominal pains, persistent diarrhoea and appetite loss.

The first-in-human clinical trial of PL-8177 is a randomised, double-blind, placebo-controlled, single and multiple ascending dose study.