Aptahem reports prepared GMP certified Apta-1 for preparation of clinical studies
Aptahem announces today that the production of Good Manufacturing Practice (GMP) manufacturing of the drug candidate Apta-1 successfully has been prepared by the collaboration partner LGC Biotechnologies in the USA, according to timeplan. The GMP manufactured Apta-1 will be used in the future clinical studies.
Aptahem’s partner LGC has improved the process parameters for the GMP production and with that obtained a more efficient CoG (Cost of Goods) which is an important part of creating an attractive partnering deal. The final delivery has met the company’s quality goals and also exceeded the amount of produced Apta-1 with 20% compared to the set goals because of the improved process parameter.
The GMP batch will now be delivered to Aptahem’s partner Recipharm for formulation and package for application in man in accordance to the regulatory requirements. The clinical study, FIM (First in Man), is thus expected to start according to plan later this year.
CEO Mikael Lindstam comments
“We are very pleased with the produced GMP certified Apta-1 and LGC’s work with refining and cost-effecting the manufacturing process, which again has taken a good step in a positive direction. We are at this point, together with LGC, leading in producing this kind of aptamers and improving the cost profile is an important aspect for potential partnering discussions.”
For further information:
Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: ml@aptahem.com
Forward-looking statements
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.
About Aptahem
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.