KoBioLabs, a company specializing in the microbiome, said Monday that it has obtained the approval of phase 1 clinical trial for its microbiome candidate drug, KBLP-002, in Australia.
A company’s second candidate drug KBLP-002 for allergic immune diseases, including asthma and eczema, has been developed by the company's original microbiome platform, SMARTiome, a KoBilLabs official said.
The company is now speeding up the clinical trials of its major pipelines as the KBLP-002 entered phase 1 trial, following a candidate drug for immune skin diseases, KBLP-001.
KoBioLabs is the only Korean company to conduct the global clinical trials of a microbiome drug, which will allow it to preempt the market if the ongoing development goes as planned.
The company has completed the administration of its first candidate, KBLP-001, for phase 1 trial, and is preparing to apply for investigational new drug (IND) status to the U.S. Food and Drug Administration for phase 2.
KoBioLabs said it is not expecting much difficulty in getting an approval for KBLP-001’s phase 2 trials because it has satisfied the requirements for global clinical trial via a pre-IND meeting with the FDA.
The KoBioLabs official said, "We will also send IND application for KBLP-002 to the U.S. regulator targeting patients with eczema or asthma in the first half of 2021 after confirming its safety, tolerance, and drug dynamics through phase I clinical trials.
KoBioLabs CEO Ko Gwang-pyo also said, "The clinical trials of the two candidates have provided us with another chance to confirm the excellence of SMARTiome technology as well as our research and development capabilities."
Ko added that the company would further solidify its position as a leader in the microbiome field by completing phase 1 clinical experiments and entering into phase 2 trials.