The biopharmaceutical startup Mallia Therapeutics GmbH has unveiled a promising new approach to treating hair loss using soluble CD83 (sCD83), an immune-modulatory protein that demonstrates potential to both stimulate hair growth and induce new hair follicle formation.
At the European Hair Research Society's (EHRS) annual meeting in Warsaw, CEO and co-founder Prof. Dr. Alexander Steinkasserer presented the company's proprietary technology, highlighting sCD83's unique dual mechanism of action in treating alopecia.
Novel Dual Mechanism of Action
The treatment works through two distinct pathways. First, sCD83 creates an anti-inflammatory environment around hair follicles by activating regulatory T cells (Tregs), which then interact with follicular stem cells to stimulate hair growth. Second, the protein directly binds to follicular stem cells, promoting the formation of entirely new hair follicles.
"Since our first identification of sCD83, we have been investigating its regulatory function within the immune system," said Prof. Steinkasserer, who is also Head of the Department of Immune Modulation at Universitätsklinikum Erlangen. "Our findings on its positive impact on hair growth and its striking ability to even activate the formation of new hair follicles have encouraged us to develop sCD83 as a treatment for people suffering from hair loss."
This approach differentiates sCD83 from existing treatments that typically only extend the life cycle of existing hair or work by systemically suppressing the immune system, often with significant side effects.
Promising Preclinical Results
Dr. Dmytro Royzman, co-founder and CSO of Mallia Therapeutics, presented data at the EHRS Conference from a preclinical androgenetic hair loss model showing that sCD83 accelerated the hair growing (anagen) phase and induced new hair growth.
Additional studies using human ex vivo systems demonstrated that sCD83 treatment prolonged the growing phase of human hair and activated hair growth-associated pathways. The research also showed that sCD83 application led to the expansion of stem cell populations within human hair follicles.
Addressing a Significant Market Need
The company is targeting both hormone-induced androgenetic alopecia (pattern baldness), which affects over 50% of men and 50% of postmenopausal women worldwide, and autoimmune-mediated alopecia areata, which affects approximately 147 million people globally.
A key advantage of the treatment is its topical application method. The sCD83 protein penetrates to the hair root and follicular stem cells but does not enter the bloodstream, potentially avoiding the systemic side effects associated with other treatments.
"While mostly regarded a cosmetical problem, hair loss can significantly affect a person's mental well-being and even lead to anxiety or severe depression," Prof. Steinkasserer noted. "We are therefore very motivated to bring a safe and effective treatment to people suffering from hair loss."
Business Development and Future Plans
Founded in June 2023, Mallia Therapeutics recently secured seed funding to continue its preclinical research. The company was co-founded by Prof. Dr. Alexander Steinkasserer, who discovered sCD83 as an immune modulator in 2001, alongside biotech expert Dr. Manfred Groeppel.
"Based on our promising early data and the financial requirements to conduct a clinical trial, we plan to raise Series A funding promptly after the completion of the seed round," said Dr. Groeppel, co-founder and Managing Director. "Given the promising results of our ongoing preclinical studies including results using tissue samples from patients, we hope to move into the clinic and start treating patients within the next two years."
The company has been selected to present at the Munich Life Science Pitch Day, a cooperation between the IZB Innovations- und Gründerzentrum Biotechnologie and the High-Tech Gründerfonds, as it seeks to advance its technology toward clinical trials.
Potential Impact on Treatment Landscape
If successful in clinical development, Mallia's sCD83 treatment could represent a significant advancement in addressing hair loss conditions. The company aims to enter the multi-billion-dollar alopecia market with what it believes will be a safer and more effective alternative to current therapies.
The topical treatment's ability to not only preserve existing hair but also generate new hair follicles could potentially address a significant unmet need in the treatment of both androgenetic alopecia and alopecia areata.
