Albert Labs International Corp (CSE:ABRT) said it has signed a Letter of Intent with full-service contract research organisation iNGENū, to carry out the company's first in-human study of its primary drug target, KRN-101.
iNGENū will conduct a randomised, double-blind study to evaluate the safety and tolerability of KRN-101 in study participants and determine its full pharmacokinetic characterization, according to Albert Labs.
Albert Labs CEO Dr. Michael Raymont said his company carefully considered a range of partners for its first in-human study and is delighted to come to this agreement with iNGENū.
READ: Albert Labs highlights "significant progress" with KRN-101, discusses plans to market in the US in corporate update
“We have been impressed by their capabilities and see a strong alignment with our core values as a company. We also greatly appreciate the assistance of the Australian government for carrying out this research,” Raymont said in a statement.
“Through this partnership, we will provide the highest standard of clinical due diligence, and risk mitigation for planned late-stage trials in the UK through expansion into the United States. We feel that this is a significant step forward in value creation for our shareholders," Raymont said.
As a unique, natural medicine containing a range of bioactives, KRN-101 is required to have its own pharmacokinetic profile despite an extensive background of safety data to support psilocybin-based medicines, said Vancouver-based Albert Labs.
The biopharmaceutical company said the study will take place in Melbourne, Australia. Including collecting all clinical outputs, the study will be carried out over eight weeks with an expected completion in 3Q 2023.
iNGENū CEO Dr Sud Agarwal said it is a privilege to have been selected as the CRO by Albert Labs' team of highly credentialed research experts to take the KRN-101 investigational product into first-in-human studies in Australia.
"This study will be conducted by iNGENū CRO at a globally-renowned research unit in Melbourne, and will yield critical data to help characterise the pharmacokinetics of KRN-101 and establish a recommended late-stage dose for future clinical trials," Agarwal said.
Upon completion, KRN-101 will be available for use in late-stage clinical trials, allowing the company to proceed with its Real World Evidence trial in the UK, which will establish the efficacy of the treatment for cancer-related distress. Albert Labs said this first in-human study also allows it to collect valuable data to enable a future Investigational New Drug (IND) application to be filed with the US Federal Drug Administration (FDA), taking KRN-101 to the largest pharmaceutical market in the world.
The company also said the Australian federal government's research and development incentive program will provide cash rebates for 43.5% of all eligible costs relating to the study.
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