May’s top news stories

18th June 2019 (Last Updated August 7th, 2019 14:27)

Novartis reported that the first clinical trial in its Phase III PLATINUM programme for QMF149 has met primary and key secondary endpoints in people with inadequately controlled asthma; and The National Institute of Allergy and Infectious Diseases (NIAID) has reported findings from a Phase I/II clinical trial of Okairos’ AdCh3NSmut1/MVA-NSmut vaccine. Drugdevelopment-technology.com wraps up the key headlines from May 2019.

May’s top news stories
Novartis AG headquarters in Basel. Photo courtesy of Andrew, Flickr.

Novartis reports positive results from Phase III trial in asthma

Novartis reported that the first clinical trial in its Phase III PLATINUM programme for QMF149 met primary and key secondary endpoints in people with inadequately controlled asthma.

Known as QUARTZ, the double-blind, randomised, multi-centre Phase III trial assessed the safety and efficacy of QMF149 in 802 participants.

QMF149 is an investigational, once-daily, fixed-dose combination of long-acting beta-agonist (LABA) indacaterol acetate and anti-inflammatory mometasone furoate.


Okairos’ hepatitis C vaccine fails to show effectiveness in trial

The National Institute of Allergy and Infectious Diseases (NIAID) reported findings from a Phase I/II clinical trial of Okairos’ AdCh3NSmut1/MVA-NSmut vaccine.

This prime-boost vaccine is intended to prevent chronic hepatitis C virus (HCV) infection in adults.

AdCh3NSmut1/MVA-NSmut failed to demonstrate effectiveness in protecting against chronic HCV infection, when compared to placebo.


BioMarin reports long-term data for haemophilia A gene therapy

BioMarin Pharmaceutical reported positive three-year data from an ongoing Phase I/II trial of its investigational gene therapy valoctocogene roxaparvovec.

Developed to treat adults with severe haemophilia A, the drug has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) and priority medicines (PRIME) access from the European Medicines Agency (EMA).

The therapeutic also received orphan drug designation from both regulators.


J&J’s Phase IIb HIV prevention trial reaches full enrolment

Johnson & Johnson (J&J) completed enrolment procedures for the Phase IIb Imbokodo clinical trial of an investigational, mosaic-based vaccine regimen to prevent HIV-1 infection.

The proof-of-concept efficacy study has recruited 2,600 women aged between 18 and 35 years that are living in five African countries that have high rates of HIV infection prevalence.

Sponsored by J&J’s unit Janssen Vaccines & Prevention, the study is evaluating the vaccine’s ability to safely and effectively decrease the rate of new HIV infections.


VIVUS enrols first patient in Phase IV trial of Qsymia

VIVUS has started patient enrolment in a Phase IV clinical trial of Qsymia (phentermine and topiramate, extended-release) capsules in obese adolescents aged between 12 and 17 years.

Qsymia holds US regulatory approval as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.

It is designed for adults with an initial body mass index (BMI) of 30kg/m2 or greater (obese), or 27kg/m2 or greater in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes or high cholesterol.


Transgene closes enrolment in Phase II lung cancer trial

Transgene completed patient enrolment in a Phase II clinical trial of TG4010 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) plus chemotherapy to treat advanced non-squamous, non-small cell lung cancer (NSCLC).

The trial recruited a total of 39 patients with low or no programmed death-ligand 1 (PD-L1) expression in tumour cells.

TG4010 is an investigational active immunotherapy designed to act against Mucin 1 (MUC1) tumour-associated antigen, while Opdivo is an immune checkpoint inhibitor.


Biogen’s MS drug reduces disease activity in Phase III study

Biogen has reported positive interim results from the ongoing, pivotal Phase III EVOLVE-MS-1 clinical trial of diroximel fumarate in patients with relapsing multiple sclerosis (MS).

According to the data, the drug was generally well-tolerated and significantly reduced disease activity.

Diroximel fumarate is an oral candidate being developed in alliance with Alkermes.

The single-arm, open-label, two-year EVOLVE-MS-1 trial is designed to assess the safety and efficacy of the therapeutic in around 1,000 patients with relapsing-remitting MS.


Paradigm reports positive RWE data for knee osteoarthritis therapeutic

Paradigm Biopharmaceuticals reported positive real-world evidence (RWE) of its injectable pentosan polysulfate (iPPS), an antithrombotic agent, in 205 patients suffering from knee osteoarthritis (OA).

Data showed a more than 50% decrease in pain across all patients.

The company noted that the latest results from 22 patients along with those from the initial 183 subjects brings the average decrease in pain scores to 51.3% across the total 205 patients.


Pfizer’s Lyrica fails to meet primary endpoint in Phase III trial

Pfizer reported top-line data from a Phase III clinical trial of Lyrica (pregabalin) as an adjunctive therapy in epilepsy patients suffering from primary generalised tonic-clonic (PGTC) seizures.

The study failed to meet its primary endpoint, demonstrating no statistically significant decrease in seizure frequency when compared to placebo.

Conducted at 70 sites in 21 countries, the randomised, double-blind, placebo-controlled, multi-centre trial assessed the efficacy of two Lyrica doses in a total of 219 patients aged five to 65 years.


OncoSec Medical releases interim data of KEYNOTE-890 trial

OncoSec Medical announced interim data from KEYNOTE-890, an ongoing Phase II study of TAVO (intratumoral IL-12) and KEYTRUDA in patients with pretreated, metastatic, chemotherapy-refractory triple-negative breast cancer (mTNBC).

Patients who earlier failed an average of 3.5 previous lines of chemotherapy were enrolled into the KEYNOTE-890 trial to analyse if TAVO (IL-12), when combined with anti-PD-1 checkpoint inhibitor KEYTRUDA, could offer meaningful clinical activity.

The first five of ten participants with refractory mTNBC (average of 3.5 prior lines of chemotherapy) indicated a quick tumour reduction of 20% or greater at the initial three-month evaluation.