ACD856 shows positive effect on brain activity in clinical trial
AlzeCure’s Alzheimer’s project NeuroRestore
AlzeCure Pharma, a pharmaceutical company that develops a broad portfolio of small molecule candidate drugs for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that the company has received new data from the clinical phase I study (multiple ascending dose, MAD) with repeated dosing of the drug candidate ACD856, which is being developed against Alzheimer’s disease and other indications with cognitive dysfunction.
New data from a planned exploratory analysis of the MAD study show that ACD856 increases EEG activity in the brain. A clear difference can be seen after versus prior to administration of the substance. This result combined with previously reported data show that the substance not only crosses the blood-brain barrier, but also reaches and activates neural pathways in the brain, with the potential of having positive effects on cognition.
The MAD phase I study is AlzeCure’s third clinical study with ACD856, the company’s leading drug candidate within the NeuroRestore platform. The substance is under development as a symptom-relieving treatment for medical conditions where the cognitive ability is impaired, for example in Alzheimer’s disease. The primary study objective was to evaluate the drug candidate’s tolerability and safety after repeated dosing. As previously reported, ACD856 shows good safety and tolerability in both the SAD and MAD studies.
ACD856 and the other substances in the NeuroRestore platform stimulate several important signaling systems and signaling substances in the brain such as BDNF (Brain Derived Neurotrophic Factor) and NGF (Nerve Growth Factor), which can lead to improved cognition, something that has been demonstrated in previous preclinical studies. New preclinical results also show potential neuroprotective and disease-modifying effects with these substances. The biological mechanism behind NeuroRestore enables several indications, such as Alzheimer’s and Parkinson’s disease, but also traumatic brain injury and depression.
“These new data are very promising and show that the substance reaches and activates neural pathways in the brain, whose normal function is disrupted in diseases such as Alzheimer’s,” said Johan Sandin, CSO at AlzeCure Pharma.
“These are very good news that add to the previous positive data for ACD856 and further strengthens our commercial opportunities for this promising substance,” said Martin Jönsson, CEO.
Shaping the future of Pharma
Artificial intelligence, robots and empowered patients are reshaping the pharmaceutical supply chain, says Dr Bertalan Meskó, Director of The Medical Futurist Institute. He will share insights on the trends influencing the future of the pharmaceutical industry at a free webinar for industry leaders on the 22nd February in the build-up to the opening of Connect in Pharma 2023 registration.
“In my webinar for Connect in Pharma, I plan to give a crystal-clear overview about where digital health technologies have been heading in the 21st century — with a special focus on AI — and why these changes are relevant to pharma companies,” says Meskó.
“From organizing logistics and equipment to drug design and drug repurposing, artificial intelligence has an immense power to automate and elevate what pharma companies have been doing,” says Meskó. “Chatbots can also revolutionize marketing by creating customized messages,” he says.
The pharmaceutical factories of the future will look more like an Amazon factory: “It will employ many robots while the staff look after them,” he says. “The workforce who service the robots will be equipped with augmented reality glasses to shorten the time required to train them for new tasks, which is similar to how the automobile industry has been using that technology,” says Meskó.
The new technology is being partially driven by the need for greater precision and advances in personalised medicine. “3D printing and bioprinting methods will be commonplace in the production of a range of products,” says Meskó. Precision bioprinters use cells and biomaterials to create organ-like structures that let living cells multiply.
Meskó says the coming changes will ultimately empower the patient: “We will see a paradigm shift in which patients become members of their own medical team. They want to engage with their health and diseases management. This means Pharma companies will have to engage directly with the patient as well as the physician. Patients will require similar information and insights about products.”
In an industry that faces heavy regulations and high stakes (patient safety understandably looms large), most pharmaceutical companies see themselves as conservative and change-averse, says Meskó. But pharmaceutical executives must embrace the changes that are now rapidly coming in order to stay competitive.
Bertalan’s talk will be followed by the official opening of registration for Connect in Pharma, a Geneva-based event focused on the pharmaceutical packaging and production sector.
As the director of The Medical Futurist Institute, Meskó helps companies, governments and other institutions understand advances in digital health technologies and bring healthcare into the 21st century. Meskó, who is a physician with a PhD in genomics, has been featured in top publications, including Forbes, BBC and the New York Times and is also a professor at Semmelweis Medical School in Budapest, Hungary. He is recognized as one of LinkedIn’s Top Voices in Healthcare.
Renan Joel, Divisional Managing Director at Easyfairs — the company organising Connect in Pharma, says industry leaders are welcome to sign up to attend the free online webinar. “Dr Bertalan Meskó is a truly modern and inspiring voice on healthcare technology,” says Joel. “His big picture analysis of the future of medicine and pharmaceutical technologies will help industry leaders get up to speed with the latest in digital innovations.”
Last patient included in Phase II clinical trial
AlzeCure Pharma a pharmaceutical company that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that the last patient has now been included in the ongoing Phase II clinical study with ACD440, the lead non-opioid drug candidate in the Painless platform, which is being developed against peripheral neuropathic pain.
This double-blind, placebo-controlled, randomized cross-over study, which is carried out in collaboration with LINK Medical Research in Uppsala, is aimed at evaluating the efficacy, safety and pharmacokinetics of AlzeCure’s lead drug candidate in pain, ACD440. The main results from the study are expected by the summer of 2023 at the latest.
AlzeCure’s drug candidate ACD440 is a TRPV1 antagonist for the local treatment of patients with peripheral neuropathic pain. The discovery of TRPV1 that underlies the project was awarded the Nobel Prize in Physiology or Medicine in 2021. There is thus a strong scientific basis for this biological mechanism, including its relationship to pain signaling. ACD440, which is also the company’s leading drug candidate within the Painless platform, completed a positive phase Ib study in 2021. It showed both very good tolerability and safety, but also a potent, long-lasting pain-relieving effect of the substance that is applied as a gel to the skin.
The medical need in neuropathic pain is very great, not least to find alternatives to opioids. The neuropathic pain market is the single largest market segment in pain management with annual sales exceeding 11 billion Dollar. Up to 80 percent of patients do not get a satisfactory effect with their current treatments.
”The study has developed well and the fact that we have now been able to include the last patient in the study means that we have good hopes that the study will also deliver the results according to what we previously communicated,” said Märta Segerdahl, MD, PhD, project leader and CMO at AlzeCure. “We see an exciting potential with ACD440, where you can broaden the further development with other formulations, thereby enabling several indications.”
“With the previous positive results from the phase Ib study, we look forward to the readout of this phase II study. There is already interest in the project and with phase II data, the project can generate even greater interest for out-licensing in a segment with a very high medical need,” said Martin Jönsson, CEO of AlzeCure Pharma.
AC-DC power adapters for medical and industrial applications
TDK Corporation announces the addition of the TDK-Lambda brand DTM70 and DTM160 series to the DTM family of compact medical and industrial AC-DC power adapters that are available in various power classes from 36 watt to 300 watt. Both series are available in Class I versions with a protective earth terminal on the input and Class II versions with double insulation protection. The adapters are housed in a robust plastic case with dimensions of only 120 x 52 x 31 millimetres (DTM70) and 150 x 70 x 38 millimetres (DTM160). The DTM70 is available with 12 volt, 15 volt, 18 volt, 24 volt, 36 volt and 48 volt output voltages and the DTM160 with 12 volt, 24 volt, 36 volt and 48 volt.
The DTM70 and DTM160 series are suitable for 2MOPP medical applications and general industrial use. Both adapter series are certified to the IEC/EN/UL 60601-1 medical safety standard for clinical applications. In addition, IEC 60601-1-11 certification is available for all Class II versions, allowing these adapters to be used in home healthcare applications. For all versions, EMC is tested according to IEC 60601-1-2 Ed 4, which simplifies use with medical equipment. For industrial and ICT (Information and Communication Technology) applications, all models are tested according to IEC/BS/EN 62368-1 and are certified for installation altitudes up to 5000 metres.
One special feature is the standard locking DIN output connector, which prevents unintentional disconnection of the output voltage of the adapter. Other connector versions and cable assemblies are available on request.
Due to the high efficiencies and the low no-load power consumption of less than 150 megawatt, the adapters comply with EU Regulation 2019/1782 (Eco-design requirements for external power supplies) and the US DOE Level VI specification. CE and UKCA markings confirm compliance with the low voltage, EMC and RoHS directives.