Aptahem has started the production of GMP certified Apta-1 for clinical trials
Aptahem can today announce that the production of Good Manufacturing Practice (GMP) manufacturing of the drug candidate Apta-1 has started at the collaboration partner LGC Biotechnologies’ facilities in the USA, with planned delivery date in early 2022. The GMP manufactured Apta-1 will be used in a product which can be administered to humans in a clinical trial.
Further process development for the GMP manufacturing has been successful with both improved quality and exchange. Aptahem’s partner LGC has yet again improved the CoGs (Cost of Goods) which is an important part in creating an attractive package for partnering discussions. All the documentation has been finalized and the production has now started according to the regulatory guidelines that apply for GMP, which means that Aptahem keeps the communicated time plan.
The clinical study, FIM (First In Man), is planned to be initiated during next year, according to plan.
“We are very pleased that our first GMP manufacturing of Apta-1 has been initiated and with that taking further steps towards clinical trials. The development process has continued to be positive and with the results we have achieved we have also paved the way for how to manufacture an aptamer like Apta-1 in large scale with high quality, which makes us a leader in this field. With this milestone we have made an important impact on drug manufacturing for advanced aptamers”, comments Mikael Lindstam, CEO.
For further information:
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
This press release contains forward-looking statements that constitute subjective estimates and forecasts about the future. Assessments about the future are only valid on the date they are made and are, by their nature, similar to research and development work in the biotech field, associated with risk and uncertainty. In light of this, actual outcomes may differ substantially from what is described in this press release.
Aptahem AB (APTA) is a biotechnology company that develops aptamer-based pharmaceuticals for the treatment of life-threatening conditions in which a combination of coagulation and inflammation are involved. The company’s primary pharmaceutical candidate, Apta-1, is being developed with the aim of preventing the high mortality rate caused by organ and tissue damage in sepsis patients, among others. The company possesses patent protection in strategic target markets and actively seeks business development opportunities with potential collaborators.