The AlzeCure Foundation is formed in the fall in a collaborative effort between a group of prominent AstraZeneca researchers, Alzheimerfonden and Professor Bengt Winblad at Karolinska Institutet.
The purpose of the organization is to develop new drugs and diagnostics for Alzheimer’s and related diseases. When AstraZeneca closes its Alzheimer research operations in Södertälje, we see a strong need to retain and further develop the important pharmaceutical research in the field of Alzheimer’s in the region and in Sweden as a whole.
A team of senior specialists in complementary fields of pharmaceutical research forms the scientific group that is the core of AlzeCure’s operations.
NeuroRestore is the first project when the Foundation initiates research and development at Novum, Karolinska Institutet in Huddinge, which becomes the natural hub for the operation.
The project portfolio is developed and expanded in part through grants and funding from international grant programs such as the Alzheimer Drug Discovery Foundation and national funding sources such as Vinnova, Swedish Brainpower, Swelife, and Alzheimerfonden.
AlzeCure Pharma is founded because its main drug candidates are considered to have great commercial potential. The two project platforms in the company are NeuroRestore, the product of in-house research, while Alzstatin derives from AstraZeneca’s research portfolio, where the project was launched on the initiative of AlzeCure’s scientists.
Johan Sandin is appointed CEO for AlzeCure Pharma in February.
In June, the company completes its first financing round to raise SEK 70 million before issue expenses.
In July, the company completes its second financing round to raise SEK 40 million aimed at financing phase I studies for ACD855.
Preclinical testing of ACD855 ends in July.
IMPD (application to commence studies in humans) for the drug candidate ACD855 is submitted in October.
The company is listed on Nasdaq First North Premier Growth Market in November.
The necessary regulatory approvals to begin phase I studies for ACD855 are granted and the company begins dosing the first subjects in December.
In March the company initiates a new drug project in the field of pain, TrkA-NAM.
The company is represented at the International Conference on Alzheimer’s & Parkinson’s Diseases where it gives two presentations.
In May the company chooses to refocus ACD855 from cognitive dysfunction to ocular indications and ACD856 becomes the primary drug candidate for cognitive dysfunction instead.
At the annual general meeting on May 22, the company resolves to issue a warrant program aimed at its Board of Directors.
In December the company obtains the necessary regulatory approvals to initiate the first clinical studies for the drug candidate ACD856 within the NeuroRestore platform. The company initiates the study shortly thereafter.
On January 7, the company in-licenses a new project, ACD440, which focuses on neuropathic pain and is in the clinical development phase.
Martin Jönsson takes over as Chief Executive Officer on January 8, 2020. Martin has worked in the global pharmaceutical industry for more than 20 years, with extensive experience from various executive posi- tions at both Ferring Pharmaceutical and Roche.
Johan Sandin takes over the position of Chief Scien- tific Officer in January, which enables him to dedicate all of his time to research and development.
Annigje van Es Johansson joins the management group in March as Head of Development & Chief Medical Officer and thereby steps down from the Board of Directors. This arrangement further strengthens the company in a period when it is developing and preparing to increase the number of clinical trials, in line with previously announced plans.
At the annual general meeting on May 20, the com- pany resolves to issue a warrant program aimed at its Board of Directors.
In June the company presents favorable data from the first clinical trial with ACD856, which showed that it has a good pharmacokinetic profile with a significantly shorter half-life in humans than its pre- decessor, ACD855, and that the candidate is suitable for further clinical development as oral treatment of conditions such as Alzheimer’s disease.
In November the company receives approval from the regulatory authorities in Sweden to initiate a Phase I clinical trial with the drug candidate ACD856.
In December the company receives approval to initiate a phase Ib clinical trial with ACD440 in neuro- pathic pain.
Favorable preclinical efficacy data for the pain project TrkA-NAM are obtained in December in an in vivo efficacy study.
The company initiates the preclinical development phase with the drug candidate ACD857 in December.
In April, Associate Professor Märta Segerdahl Storck, MD/PhD, assumed the position of Chief Medical Officer (CMO). Dr. Segerdahl is responsible for the company’s clinical development activities. She is also part of AlzeCure’s management group.
In April, positive and significant efficacy data were obtained slightly ahead of plan from the company’s Phase Ib clinical trial with the drug candidate ACD440 for neuropathic pain. The drug candidate was also well tolerated as a topical treatment.
Eva Lilienberg was elected to serve on AlzeCure’s Board of Directors at the Annual General Meeting in May. Eva further strengthens the company with her broad international regulatory and commercial experience.
In August, the company received approval from the Medical Products Agency to be able to further esca- late the dose of ACD856 in the Phase I clinical trial (single ascending dose, SAD). The approval is based on the good tolerability of the drug candidate, which enables higher doses to be tested.
In August, the company received approval from the regulatory authorities in Sweden to initiate a Phase I clinical trial (multiple ascending dose, MAD) for the drug candidate ACD856, with a focus on Alzheimer’s disease.
In October, the first study participant in the compa- ny’s Phase I clinical trial (MAD) received a dose of the drug candidate ACD856.
The company received a guiding response from the FDA supporting the continued clinical development program for ACD440, and preparations for the upcoming Phase II clinical trial.
The new share issue was completed on March 22 and raised SEK 48.5 million before issue expenses for the company. Issue expenses totaled SEK 7.2 million.
In March, the company received new indicative data from the ongoing clinical phase I MAD study with ACD856 (NeuroRestore) showing that the substance reaches the brain, the target organ for the substance which is developed as a treatment for Alzheimer’s disease.
A directed set-off issue was carried out in April in connection with ACD440 entering phase II and Acturum Life investing in the company. The set-off issue is the result of a previously agreed milestone payment, which will be made in the form of 845,070 shares instead of a cash payment.
In April, the company presented results from the Phase I Single-Ascending-Dose-clinical study, which show that ACD856 has a good safety and tolerability profile in humans, as well as suitable pharmacokinetic properties, both of which support further clinical development of the substance. In addition, new preclinical data were also presented, demonstrating a dose-dependent positive effect of the NeuroRestore compound on mitochondrial function, which is particularly interesting since impaired mitochondrial function is common in conditions such as Alzheimer’s disease.
In April, the company also presented new data concerning a new potent small-molecule gamma-secretase modulator (GSM), part of the Alzstatin research platform. The presentation contains preclinical data from studies that show that the substance, AC-0027875, effectively crosses the blood-brain barrier and reaches the target organ, i.e. the brain, in high concentrations – which is essential for a good pharmacological effect. Furthermore, data show that the potent effect of the substance on gamma led to a reduction in the amount of harmful amyloid beta 42 (Aβ42) by more than 50 percent.
In May, the company received approval to start a Phase II clinical trial with the non-opioid substance ACD440 for the treatment of neuropathic pain.
The Phase I clinical trial Multiple-Ascending-Dose for AlzeCure’s Alzheimer’s project NeuroRestore ACD856 ended in June. The data show that ACD856, the primary drug candidate in the company’s NeuroRestore platform, has good tolerability and safety. Furthermore, the results demonstrate that the substance has suitable pharmacokinetic properties with rapid uptake into the body, as well as relevant and dose-dependent exposure in the CNS.
In September, the company communicated that a patent was approved for ACD856 in the US.
On September 16, the company presented new data from the Phase I clinical trial (multiple ascending dose, MAD) in the NeuroRestore project, which show that ACD856 has a pharmacodynamic effect on EEG activity in healthy volunteers. The new EEG results show that ACD856 not only crosses the blood-brain barrier, but also has a demonstrated effect on EEG activity in the brain.
In September, AlzeCure presented new data on the anti-inflammatory effects of the TrkA-NAM pain project at IASP 2022.
The company publishes new data at the ISMND Conference demonstrating that NeuroRestore ACD856 improves mitochondrial function and increases BDNF levels in neurons.
The new share issue was completed on December 20 and raised SEK 42.6 million before issue expenses for the company. In all, 134.3 percent was subscribed with and without exercising subscription rights. Issue expenses totaled SEK 3.0 million.