Aptahem adjusts the schedule and capital requirements as a result of the decision to update the clinical development strategy
Aptahem’s preclinical programme is proceeding with the gradual collection of data on the Apta-1 effect profile, while the work on the company’s clinical development is proceeding in consultation with external experts. Dialogue with opinion leaders and potential partners has shown that the unique mechanism of Apta-1 can create a larger market than the company originally hypothesised. These new opportunities are deemed to be of such value that the company has chosen to update the clinical development strategy. The adjustment means that the schedule and estimated costs of the development programme must be changed, which is why the Board decided that a plan for additional funding must be developed. This will be presented to shareholders in 2017.
Aptahem develops drug candidates for the treatment and prevention of diseases that cause blockages in blood vessels, such as deep vein thrombosis, stroke or heart failure. Aptahem’s main candidate, Apta-1, has been developed as a new type of treatment, with anticoagulant and anti-inflammatory effects. Today, the treatment of blood clots is a vast market, in which leading drugs are associated with an increased risk of bleeding. Apta-1 belongs to a different class of compounds than the currently available therapies, and in preclinical models has not increased the risk of bleeding, and very high doses have not shown any relevant adverse effects.
Aptahem today announced that the Board of Directors decided on an updated development plan that aims to optimise the Apta-1’s therapeutic potential based on the combined anti-inflammatory and anticoagulant effects. The new strategy has been implemented in order to more quickly achieve a proven clinical effect (proof-of-concept) and to shorten the time to a first market approval for Apta-1. Operational project planning is proceeding with possible trial managers, development organisations (clinical research organisations) and contract manufacturers before the start of the company’s first clinical study. These dialogues with suppliers have shown that, according to GMP (Good Manufacturing Practice), the production of clinical material will not be able to follow the previously communicated timeline. The revision means that an application for clinical trials may first be submitted to the Authority at the end of 2018, which postpones Aptahem’s scheduled study start.
“During the year, Aptahem took important steps towards building up the company’s development expertise and organisation. Our clinical strategy will meet key market needs and best utilise the benefits of Apta-1. I believe, therefore, that it is important that we are willing to adapt our plan on the basis of these new insights, even though our previous plan must be revised. My overarching job is to maximise value for our shareholders, and I believe that our new development makes Aptahem stronger than ever”, says Mikael Lindstam, CEO of Aptahem.
The updating of the development plan has changed capital requirements. A more detailed picture of Aptahem’s development plan and timeline will be presented to shareholders later this year, when the Board will present a financing proppsal.
For further information:
Mikael Lindstam, CEO Aptahem AB
Tel: + 46 (0)766-33 36 99
This communication contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their nature, as well as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
This information is information which Aptahem AB (publ) is obliged to publish under the EU Market Abuse Regulation. The information was provided by the auspices of the above contact person, for publication on March 29, 2017.