ATHANA reaching first phase completion of nanoparticle antifungal project

Gera, Germany –The ATHANA alliance is approaching completion of the first phase of its work, which aims to develop novel antifungal therapies through targeted transport of active pharmaceutical ingredients (APIs) by an innovative nanoparticle technology. High‑potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) is responsible for stability testing and regulatory issues relating to a future transition to the GMP (Good Manufacturing Practice) environment.

With the main project milestone (proof of concept) close to being achieved, the founding phase of the project remains on schedule for completion by May 2026.

ATHANA Alliance

The ATHANA – Antifungale Therapie‑Ansätze durch nanopartikuläre Zielsteuerung von Wirkstoffen (“Antifungal therapy approaches through nanoparticulate targeting of active ingredients”) alliance brings together HAPILA and five industry partners as well as two academic partners based in and around Jena, an international science hot-spot with a tradition of interdisciplinary projects between universities, research institutions and industry. Collectively, the partners cover the full value chain required for the pharmaceutical development of nanoparticle‑based dosage forms.

The project is coordinated by SmartDyeLivery GmbH, which provides its platform technology and is responsible for nanoparticle design, formulation, and process upscaling. HAPILA GmbH contributes its expertise in the areas chemical synthesis, stability testing, and the preparation of associated regulatory documentation.

Further partners and their roles include:

• Leibniz Institute for Natural Product Research and Infection Biology – Hans Knöll Institute (Leibniz‑HKI), Jena: in vitro and in vivo testing of nanoparticles
• Dyomics GmbH, Jena: identification and development of functional targeting dyes
• Jena Bioscience GmbH: development of room temperature-stable dosage forms
• University Hospital Jena: clinical partner
• BioControl Jena GmbH: mathematical modelling of pharmacology
• Dynamic42 GmbH: three‑dimensional cell models and toxicity screening

Together, the alliance is developing innovative formulations and applications based on highly targeted, region‑specific nanoparticle delivery of an established API for the treatment of fungal pulmonary infections. Compared with conventional oral solid‑dose therapies, this approach is expected to deliver improved bioavailability with reduced systemic side effects.

Frontrunner testing

Initial Frontrunner test samples of the nanoparticle‑encapsulated API have been successfully developed and meet predefined target specifications. These samples are now being tested for therapeutic efficacy in an infectious animal model at Leibniz‑HKI.

Completion of the proof‑of‑concept animal studies for inhalation administration is scheduled for mid‑2026. This milestone will mark achievement of the project’s initial objective: development of a drug prototype suitable for preclinical efficacy and tolerability studies targeting invasive pulmonary aspergillosis.

The work to date has included development of API‑loaded nanoparticles capable of recognizing pathogen‑specific structures, enabling selective targeting of fungal pathogens. The platform is designed as a modular system that can be expanded and adapted to additional indications.

Meanwhile, HAPILA continues to perform stability and stress‑testing studies on Frontrunner samples.

Federal funding

The ATHANA project is funded by Germany’s Federal Ministry of Education and Research (BMFTR, previously: BMBF) as part of the RUBIN program– Regional Entrepreneurial Alliances for Innovation.

HAPILA CEO, Dr. Uwe Müller commented: “The ATHANA project is showing very promising progress and potential. “

“Classical antifungal therapy approaches in the form of tablets are systemic rather than targeted. The increased specificity for the area/site of action of the API made possible by the administration of nanoparticles leads to much higher bioavailability with fewer side effects,” Dr. Müller noted.

CDMO capabilities

“As this project has progressed, HAPILA has confirmed itself a highly capable CDMO partner with our ability to contribute cost-effective solutions that are also highly scalable to industrial manufacturing. This includes synthesis development as well as purification methods.”

“Our expertise in GMP-regulated synthesis development and scale up, regulatory support, and our technical capabilities have all been needed for this complex project to develop new and innovative drugs with unique and very specific synthetic challenges,” he concluded.

HAPILA has previously demonstrated its capabilities in comparable partnerships, including the development of the innovative anti‑tuberculosis antibiotic candidate BTZ‑043, where work progressed from small‑scale synthesis through to GMP‑certified API manufacture for Phase II clinical trials.

The progress made within the ATHANA project will be presented at a user conference (Anwendertagung) on April 21, 2026.

About HAPILA GmbH

HAPILA GmbH is a contract development and manufacturing organization (CDMO) that provides high-value services to pharma, biotech and fine chemicals client companies in the development and cGMP manufacture of active pharmaceutical ingredients (APIs), including highly potent active pharma ingredients (HPAPIs).

HAPILA is an independent company with deep experience in GMP-related development and GMP manufacturing, offering a fully regulated service for APIs (IMPD, ASMF) to very high scientific and quality assurance (QA) levels.

It supports the development and manufacture of drug products using patented processes and in-depth experience in the API value-creation chain from synthesis and purification to particle design through microcrystallisation of API.

The company’s mission is to supply exclusive products of the highest quality, potency and safety in compliance with GMP and environmental protection guidelines. All HAPILA work focuses on product quality and customer satisfaction.

All chemical synthesis is carried out in-house at HAPILA’s GMP certified laboratories in Gera, Thuringia, in east-central Germany.

When combined with purification and particle design, HAPILA’s chemical synthesis services cover the complete API value-creation chain, enabling it to be a highly efficient bridge-builder between API production and pharmaceutical end-use.

For more information, visit: www.hapila.de/ecom

Resources

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