Global Long-acting Therapeutics News from January 2024
There's been a lot of news and announcements about long-acting medications from around the world this month. Here are some key pieces from other researchers that we think will interest you.
As well as research for specific diseases and viruses that we'll highlight below, controlled-release drugs and delivery systems research has made enough noise that it's receiving more general attention. With market researchers including discussion of long acting injectables within questions about new trends, such as this interview with Windgap Medical closely following pieces like this article from Business Wire about a specific report on the impact of this newly emerging but rapidly growing market within the health sector.
More general news from long-acting therapeutic research includes some announcements around exciting new drug delivery systems, such as Daré Bioscience, Inc., a leader in women’s health innovation, announcing technological proof of concept "for DARE-LARC1 and the underlying innovative drug delivery platform designed to store and precisely deliver therapeutic doses over months or years through a single device". This technology will dramatically reduce the treatment burden of those requiring frequent dosing or regular injections due to its key features: Precision dosing, Extended duration and dosing interval control, No external charging or recharging required, Upgradable platform, Two-way communication, Smartphone integration. Read more about the system here.
Only a short time later, a team at North Carolina University published their work on a smartphone controlled wearable drug delivery patch. Rather than have to organise doses of multiple drugs at various times, the Spatiotemporal On-Demand Patch allows the release of multiple medications on demand and will be wearable like a plaster. Find out more about their work here.
HIV Medication and Prevention News
At the start of the month, news was circulating about a new dapivirine vaginal ring from Zimbabwe and how the work was a masterclass in reducing the time from research to product release. The ring insert has been praised for its controlled-release over one month, its efficacy of reducing the risk of contracting HIV by 75%, that it's discreet, but also because use is controlled by its female users. You can read the original article here.
Calibr, the drug discovery and development division of Scripps Research, have announced a license agreement with Gilead Sciences to develop a long-acting HIV antiviral agent designed for combination treatment with lenacapavir. Their aim is to create a "best-in-class long-acting HIV regimen". Increasing medical options around HIV helps address the diversity of those who are impacted. The original article can be read here.
Health Canada has granted priority review status to ViiV Healthcare for what could be Canada's first long-acting therapy for PrEP for sexually acquired HIV-1 infection. "We believe that ViiV Healthcare is one step closer to providing Canadians with a long-acting option to protect themselves against HIV, reaffirming our commitment to end the HIV epidemic." Read the full article here.
In their work to prevent HIV infection, the National Institutes of Health have succeeded in an animal proof of concept study, where three separate HIV antibodies protected monkeys from contracting simian-HIV. This research is another step towards their goal of improving preventative measures in humans. Read more here.
Long-acting Diabetes Treatment News
Sciwind Biosciences have had positive results in Phase 1 of their work to create long-acting treatments for type 2 diabetes and obesity. The study continues and will include a move to long-acting once weekly administration for patients with obesity. The original article can be read here.
Researchers in Zhejiang University have created a smart long-acting insulin. One treatment under the skin lasts for over a week by slowly releasing insulin in response to blood sugar levels. Read about this new step towards easier insulin management here.
Respiratory Syncytial Virus (RSV)
A long-acting monoclonal antibody from AstraZeneca and Sanofi called 'Beyfortus' has been approved for use in China. Beyfortus has been approved for the prevention of RSV in infants and neonates. It is the first approved preventative option to protect against RSV and "a single dose of Beyfortus demonstrated consistent efficacy against RSV lower respiratory tract disease (LRTD) extending through five months, the duration of a typical RSV season." Read the full article here.
Cardiovascular Disease (CVD) / Cholesterol
The American Heart Association's investigation into long-acting injectable PCSK9 inhibitor recaticimab received some attention in a Top Cardiology and CVD list, due to the REMAIN-2 trial more than halving low-density lipoprotein (LDL) cholesterol levels, with one dose lasting up to three months.
Tourmaline announced exciting advancements for their subcutaneous TOUR006. The drug is in phase 3 trial for Thyroid Eye Disease and phase 2 aligning with the FDA on the clinical development programme for use with Atherosclerotic Cardiovascular Disease to evaluate quarterly dosing on the disease. Top line data for both is expected in 2025. You can read their full article here.
Inclisarin, a drug that lowers LDL cholesterol, will soon launch in India. Brand name Leqvio, this jab only needs to be administered twice a year. This extended release formulation "ensures consistent and effective LDL cholesterol reduction throughout the year, relieving patients from the burden of frequent medication administration". It does this through RNA interference, working at a genetic level to prevent the liver from producing a certain protein. Read more here.
Schizophrenia
Earlier in the month we saw the announcement that phase 3 trials have shown the success of a long-acting risperidone, with a weekly dosage via the Lynx platform achieving the same drug levels as daily doses of risperdal. The Lynx drug delivery platform was developed by Lyndra Therapeutics and the pivotal safety trial of the platform starts this year. You can read the full article here.
Teva Pharmaceuticals have achieved the full cohort of participants needed for the phase 3 trials of their controlled release olanzapine. The results are due later this year and, if successful, will mean the first long-acting subcutaneous injectable of olanzapine for people with schizophrenia. The atypical antipsychotic will only need to be administered once a month, reducing medication burdens for those prescribed it. Find out more here.
Hepatitis
Boston Pharmaceuticals presented findings this month highlighting success in a phase 2a study. They found low risk of immunogenicity and positive clinical effects from their long-acting analogue for the treatment of metabolic dysfunction associated steatohepatitis (MASH). Administration of the drug not resulting in the generation of anti-drug antibodies is a key finding in this research as MASH patients require sustained powerful efficacy over time. Using markers of liver injury and fibrosis in MASH patients, the trial also demonstrated the positive impact of the treatment on several non-invasive indicators of fibrosis. Read the original article here.
We'll be highlighting Global News weekly from now on, so keep an eye on our Twitter and our LinkedIn to see what else has been making global waves in long-acting therapeutics.