Novartis and Medicines for Malaria Venture MMV have announced that they are to progress the ganaplacide/lumefantrine solid dispersion formulation (SDF) into phase 3 development.

The treatment involves patients with acute uncomplicated malaria due to Plasmodium falciparum and is a response to increased concern over resistance to existing therapies.

Ganaplacide is a novel agent with a new mechanism, which is combined with a once-daily formulation of lumefantrine. This combination has the potential to clear malaria infection – including artemisinin-resistant strains – while also blocking transmission of the parasite. Currently, the medicine is being developed with scientific and financial support from MMV and its partners.

Due to start in 2023, one large phase 3 pivotal trial will compare the efficacy of ganaplacide/lumefantrine-SDF to the current ‘gold standard’ artemether-lumefantrine therapy. The trial will be conducted in collaboration with the WANECAM 2 consortium and will include partner clinical sites in Burkina Faso, Mali, Gabon and Niger as well as other sites in sub-Saharan Africa.

Meanwhile, a phase 2 open-label, randomised controlled study was conducted among 524 adults and children with acute uncomplicated malaria due to Plasmodium falciparum infection. During the research the ganaplacide/lumefantrine-SDF combination met the primary objective in all patients.

In patients who received a once-daily dose of ganaplacide/lumefantrine-SDF during three days, response to treatment was similar to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during the same time period.

According to the latest World Malaria Report – released in December 2021 – there were an estimated 241 million cases of malaria and 627,000 resulting deaths worldwide in 2020.

Lindis Biotech has announced positive data from all three dose groups from its ongoing Catunibla phase 1 trial. The objective of developing the drug candidate is to reduce the rate of radical bladder removal – also known as cystectomy – as well as to decrease recurrence and progression rates.

The study has been testing the trifunctional anti-EPCAM/CD3 monoclonal antibody catumaxomab and has demonstrated an excellent safety and tolerability profile in addition to preliminary efficacy. Indeed, data from all three dose levels confirmed the findings from the two lower dose levels that were announced previously. As with previous findings, catumaxomab was well tolerated and there was no dose-limiting toxicity.

Meanwhile, the observed reduction of urinary EpCAM positive cells during and after catumaxomab treatment suggested that the trifunctional bispecific EpCAM targeting antibody binds and efficiently kills EpCAM-positive bladder cancer cells in the urine milieu. This also demonstrates considerable potential to extend the tumour-free period within treatments and to considerably reduce the number of BCG instillations required.

Dr Horst Lindhofer, founder and chief executive officer of Lindis, explained: “We are pleased to see the progression of the Catunibla study into its next stage. Our previously released compassionate use data, as well as the positive results and follow-up data from the dose escalation are strongly encouraging.”

Infex – a company focusing on anti-infectives – has announced that the first patients have been dosed in its phase 1 study researching candidate RESP-X.

The treatment is a new anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients. Pa is a critical factor in this respiratory disease, leading to recurring episodes of life-threatening infection – currently there are no approved preventative treatments.

Research involves a 32-subject, first-in-human, double-blind, placebo-controlled, ascending dose study, delivered intravenously to groups of healthy volunteers. During the course of the trial, it will evaluate the tolerability, safety pharmacokinetic, pharmacodynamic and immunogenicity profile of the drug.

Top line results from the study are expected to be available in 2023 and will be used to inform further clinical trials in NCFB patients in order to reduce the severity and frequency of Pa-mediated exacerbations.