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.