Kolon Life Science said the U.S. Food and Drug Administration has allowed the company to resume the phase-3 clinical trial of Invossa-K, gene therapy for osteoarthritis, in the United States.
The FDA lifted the clinical hold of the drug almost a year after it suspended the study in May last year. Although the Korean regulator revoked the license of Invossa in the local market due to an ingredient mislabeling, the FDA’s latest decision gave Kolon a fresh start of the Invossa business in the U.S.
On Saturday, the FDA sent the official notice to Kolon TissueGene, a subsidiary of Kolon Life Science, that it would remove the clinical hold on the phase-3 trial of Invossa.
According to Kolon TissueGene, the FDA said all the issues of the clinical hold were resolved, and the company could continue the clinical trial of Invossa.
Kolon started the phase-3 study on Invossa in the U.S. on Oct. 30, 2018, but the FDA suspended the trial in April 2019 due to the mislabeling issue. The company admitted that the cell ingredient of the second fluid of the drug was not a cartilage-derived cell but kidney-derived one, also known as GP2-293. The FDA sent the notice of the clinical hold to Kolon TissueGene in May 2019.
After submitting additional data to the FDA twice, the company was cleared of the clinical hold on Saturday.
Earlier, the FDA requested the company to submit supplementary materials, including properties of Invossa’s ingredients such as evaluation of the cell’s identity, how the composition of the drug changed, and upcoming measures. Besides, the regulator demanded more analysis of Invossa ingredients’ properties.
Despite the removal of the clinical hold, the FDA asked the company to submit data on the stability of clinical samples and improvement measures for Invossa production processes.
“The FDA’s request has nothing to do with the lift of the clinical hold. We can meet their request sufficiently,” an official at Kolon TissueGene said.
Kolon TissueGene said it would go ahead with testing the drug in the participants of the study after completing the supplementary procedures for the clinical trial protocol and getting informed consent form from patients, in consultation with the FDA.
The resumption of the Invossa trial in the U.S. gives Kolon Life Science and Kolon TissueGene some breathing room after the Korean regulator removed the drug from the domestic market.
Last year, the Ministry of Food and Drug Safety nullified the permit for Invossa due to the labeling error of the drug ingredient.
The prosecution suspected that the company had known about the mislabeling and allegedly submitted fake data to win the license. The prosecution indicted Kolon executives, including Kolon Life Science CEO Lee Woo-sok, and the trials are in progress. Kolon TissueGene is also accused of going public while concealing the mislabeling.
Kolon Life Science faced a significant challenge, particularly regarding a licensing agreement with Mundipharma. The company partially changed the licensing deal with Mundipharma to return 15 billion won ($12.8 million) upfront payment to Mundipharma, depending on circumstances involving Invossa and set up a period for the right of pledge.
The right of the pledge was valid until the U.S. decides on the resumption of the phase-3 clinical trial, and the Korean regulator approves the resumption of the Invossa sale. The latest FDA decision met one of the two conditions for the right of pledge.
Industry officials are observing how the resumption of the U.S. trial of Invossa will affect the criminal trials on Kolon executives in Korea.
Some said the resumption of the U.S. test would not have a significant impact on local trials because the trials were about false reporting and omitting public disclosure of important information.
However, in administrative trials regarding the cancellation of the Invossa license, the company might use the FDA’s decision as evidence to support the drug’s safety, observers said.
While the food and drug ministry claims it could nullify the permit based on the mislabeling of GP2-293 cells as cartilage-derived cells, the administrative court plans to hear experts’ appraisals to prove Invossa’s safety at the request of Kolon.