Lactocore Group has started an investigational new drug (IND) application-enabling studies and plans to advance its lead peptide therapy LCGA-17 to clinical development in the first half of 2024, CEO and co-founder Anton Malyshev told Clinical Trials Arena.

Lactocore plans to monitor translational biomarkers such as electroencephalogram (EEG), in addition to standard safety parameters as part of the planned Phase I trial. The company has partnered with the Centre for Human Drug Research (CHRD) in the Netherlands to measure several additional parameters including eye movements.

LCGA-17 was developed using Lactocore’s structure-based drug discovery platform. “We identify specific protein receptors like G protein-coupled receptors (GCPR) and kinases, which have been validated for drug discovery and development. On these, we apply Lactocore’s proprietary bioinformatics approach Reptide,” said Malysev.

Reptide has two technologies. One is docking-based with the proprietary rescoring function technology to pick up the best peptides from the short peptide databases. The second is the fragment-based drug discovery approach, which allows for the aminoacid-by-aminoacid construction of a peptide that is suited to the protein binding site.

LCGA-17 is being investigated as a treatment for anxiety disorders, including generalised anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder. Lactocore has completed animal testing for both chronic and acute stress in six different animal models.

More than 1,500 clinical trials for treating anxiety have been initiated in the last decade, as per GlobalData analysis.

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Preclinical pipeline

Other drugs in Lactocore’s pipeline include a short-chain peptide CHM-273 that regulates free fatty acid receptor 2. Malysev added: “We have already performed tests using animal models with unhealthy diets such as high-fat and high-sucrose diets. We saw that the peptide can regulate insulin resistance and blood glucose levels, thereby, helping with weight management and lipid accumulation. It also shows reductions in systemic inflammation.”

Lactocore’s earliest pipeline candidate is LCGM-10, which is a mild stimulant “similar to caffeine but without the rebound effect”. Its therapeutic use in different neurological disorders, particularly in dyskinesias, is currently under review.