BioStock Article: Aptahem reports growing buzz around Apta-1

BioStock published an article on 1 April 2025 about Aptahem, which can be read in full below.

Malmö-based Aptahem recently released detailed plans of their upcoming phase II study with candidate Apta-1, set to prove its multifaceted potential and optimise future market opportunities. Meanwhile, the company has intensified partnership discussions, noting increased interest from major players following BIO-Europe in Milan.

Aptahem develop RNA-based treatments for life-threatening acute conditions driven by coagulation, inflammation, and tissue damage. Preclinical studies of lead candidate Apta-1 have shown promise in treating sepsis and related critical conditions, demonstrating anti-thrombotic, immunomodulatory, and tissue-repairing properties.

Phase II study will target multiple indications
The upcoming phase II study has a basket trial design, allowing the company to evaluate Apta-1’s efficacy and safety across multiple indications involving inflammation and coagulation – e.g. such as acute urogenital diseases, kidney injuries, and pulmonary conditions – within a single trial. The preliminary study design is set to be refined with the input from clinical experts and regulatory authorities.

The idea is, however, to align with Apta-1’s expected therapeutic effects and focus on the following key areas:

• Acute Urogenital Diseases (projected market exceeds $10 billion)
• Inflammatory Kidney Diseases and Acute Kidney Injury (market surpassing $75 billion)
• Pulmonary Diseases and Acute Lung Injuries (presenting a growing market need)
• Coagulation Disorders in Acute Conditions

According to the company, Apta-1’s ability to address multiple therapy areas with unmet needs positions it as a potential ‘first-in-class’ treatment.

Partnerships and manufacturing progress
Recently, Aptahem finalized a clinical synopsis tailored to Apta-1’s properties and secured bio- and organ markers, which have been key in discussions with potential partners, investors, Key Opinion Leaders, clinical stakeholders, and contract research organizations.

Following BIO-Europe in Milan, Aptahem reported an increase in interest from desired partners. The company notes that the publication of Apta-1’s mechanism of action and clinical synopsis has been met with enthusiasm, leading to concrete discussions with major biotech and pharmaceutical companies about advancing Apta-1 into clinical trials. Some partnership discussions are now in advanced stages, focusing on details and formats for potential licensing agreements.

In a recent stakeholder newsletter, CEO Mikael Lindstam notes that the growing interest in oligonucleotide-based treatments, like Apta-1, reflects a market shift toward smarter alternatives to traditional antibodies. In parallel, Aptahem has prioritized optimizing Apta-1’s manufacturing process, an important factor in partnership negotiations.

The CEO notes that its collaboration with Ajinomoto has been valuable, and the company is now exploring alternative production methods with other manufacturers that could reduce costs by 2–5 times, depending on volume.

Scientific and future developments
What’s more, Aptahem’s scientific collaborations are also progressing. The company anticipates new publications that will further establish Apta-1 as a novel solution in its therapeutic areas. Additionally, Aptahem is exploring technical partnerships to develop bioanalytical methods for rapid assessment of acute conditions and alternative administration methods for emergency settings, potentially benefiting areas like defense and field medicine for soldiers, and opening new investment and development opportunities.

CEO Lindstam emphasizes that, with a robust drug candidate, a strong patent portfolio, and a clinical strategy aligned with market needs, Aptahem is well-positioned for growth. Lindstam also highlights that ongoing discussions with investment funds, private capital entities, and biotech/pharma investment arms – supported by the clinical synopsis – reflects a strong interest in Apta-1.

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