Key Takeaways
- Mallia Aesthetics plans to launch its hair growth product, MAL-838, under the EU Cosmetics Regulation by year-end.
- Independent testing confirms the safety and microbiome-friendly nature of MAL-838 and its 8T3 formulations.
- MAL-838 utilizes the protein sCD83, which promotes hair growth by activating key regulatory pathways.
Innovative Approach to Hair Growth Products
Mallia Innovations GmbH is advancing its hair growth compound, MAL-838, through its subsidiary, Mallia Aesthetics GmbH. Targeting a market release under the EU Cosmetics Regulation, the product aims to be available by the end of the year. In parallel, Mallia Therapeutics is working on a different formulation of the compound for treating androgenetic alopecia and alopecia areata.
Mallia Aesthetics reports significant progress in the development and regulatory approval of MAL-838, part of a hormone-free product line branded as 8T3. This product leverages the human soluble protein sCD83, which has demonstrated the potential to stimulate hair growth and activate growth-related signaling pathways in various laboratory studies. While these promising effects are noted, EU Cosmetics Regulation prohibits the company from making specific therapeutic claims, reserving such promotions for medicinal products.
Ahead of its planned fourth-quarter launch, Mallia Aesthetics has successfully completed the safety evaluation of all 8T3 products per EU Cosmetics Regulation 1223/2009. An independent laboratory has validated the safety of MAL-838 through thorough in vitro and in silico testing, paving the way for its introduction as a cosmetic product. Furthermore, MAL-838 is now registered in the European Cosmetic Ingredients Database as sh-Polypeptide-167, confirming the product’s regulatory compliance and market readiness.
In addition to safety assessments, independent testing has also attested to the microbiome-friendly attributes of the 8T3 formulations containing MAL-838. Unlike traditional solvent-based hair growth solutions, these products do not alter the healthy skin microbiome, making them a more holistic choice for consumers.
The protein sCD83, co-identified by Prof Dr Steinkasserer, is essential to the development of both topical treatments for hair loss (MAL-856) and stimulation of hair growth (MAL-838). It works by activating regulatory T cells that interact with hair follicles, preventing follicular cell death while stimulating follicular stem cells, leading to new hair growth. Importantly, sCD83, being a 45 kDa protein, does not penetrate skin barriers to act systemically, ensuring a targeted effect.
This innovative approach to hair growth therapies places Mallia Aesthetics at the forefront of hair care solutions, offering promising alternatives in an ever-evolving market.
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