Lindus Health and Acinonyx Bio to Partner in Clinical Trial Evaluating a Benzoyl Peroxide Alternative

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Lindus Health and Acinonyx Bio recently announced their collaboration to develop a cosmetic clinical trial investigating Acinonyx Bio's topical cream, ACX, for the treatment of inflammatory acne. The study will focus on Propionibacterium acnes (P. acnes) in the development of inflammatory acne.¹

According to the news announcement, previous in vitro studies showed that ACX killed P. acnes as rapidly as benzoyl peroxide. The clinical trial will include patients with moderate to severe inflammatory acne and will be conducted as a decentralized clinical trial model, allowing patients the flexibility to participate in the clinical trial within the comfort of their real-world environments. Patients will use the topical treatment for 6 weeks and provide photos for medical assessment, as well as their opinions on the efficacy of ACX and their overall satisfaction.

Lindus Health is responsible for providing end-to-end study management, including protocol development, regulatory submissions, recruitment, monitoring, data management, and more. Lindus Health will use its in-house virtual site and digital marketing capabilities to complete patient recruitment through digital advertising. The company will also design a dedicated study website with permanent trial information including leveraging their proprietary eClinical platform, Citrus, for patients to easily complete pre-screening and eConsent.

"Lindus Health's involvement in this study underpins our commitment to helping our partners bring safe and effective dermatological therapies to market. Inflammatory acne can significantly diminish quality of life. We are enthusiastic about the opportunity to leverage our unique technical and service-based capabilities in another dermatology study, building on our vast experience in this space,” said Michael Young, co-founder of Lindus Health, in the news release.

According to Lindus Health, positive results from this clinical trial would further emphasize the potential of ACX as a novel topical cream for the treatment of patients with inflammatory acne.

"We are optimistic about the development of our topical cream and the effect it will have on patients. We are incredibly excited to be working with Lindus Health to bring our study to life and aid in the overall journey of potentially bringing a safer alternative to the hands of individuals suffering from inflammatory acne,” concluded Alex Michalow, chief executive officer of Acinonyx Bio, in the news release.

Companies may be looking into benzoyl peroxide alternatives due to findings earlier this year of benzene, a human carcinogen, found in benzoyl-peroxide containing acne products at room temperature and beyond. On March 5, 2024, Valisure LLC, an independent testing laboratory, filed a petition with the US Food and Drug Administration requesting a recall of treatments affected by elevated levels of benzene in order to allow regulators to investigate.²

Valisure tested 66 BPO products and found high levels of benzene when BPO products were incubated at 37 °C (98.6 °F: body temperature), 50 °C (122 °F: accepted pharmaceutical stability testing temperature), and 70 °C (158 °F: hot car temperature).³

“There have been concerns that, superficially, when you look at the petition, that it’s all about elevated temperatures. That is not true. Benzene was also found extensively at room temperature on the shelf and off the shelf. This important fact cannot be overlooked. The focus of the petition is stability studies,” said Christopher Bunick, MD, PhD, FAAD, an associate professor of dermatology and a physician-scientist at the Yale School of Medicine in New Haven, Connecticut, in a presentation at the 2024 American Academy of Dermatology Annual Meeting in March.³

Of the 66 products tested at day 0 at room temperature, 10 of the products had more than 10 ppm of benzene and 19 products had more than 2 ppm of benzene. According to Bunick, the biggest problem with BPO is degradation, not contamination. He also reminded attendees that although the FDA permits up to 2 ppm of benzene, that is only if it is absolutely necessary to manufacture said product and that product represents a major medical advance. Bunick added that with so many other acne treatments available, it is not absolutely necessary to manufacture BPO with unsafe levels of benzene, even at 2 ppm.³

“With Valisure’s agreement, for those providers and patients who wish to continue using benzoyl peroxide–containing products, a proportional response at this time would be to keep the product refrigerated at all times, renew the medicine every 3 to 6 months, and avoid heated storage. This will not necessarily eliminate all benzene but should slow its decomposition. This measure gives the medical community a chance to await further investigation and recommendations,” Bunick told Dermatology Times.

References

1. Lindus Health announces cosmetics clinical trial with Acinonyx Bio to evaluate an alternative to benzoyl peroxide for inflammatory acne. News release. PR Newswire. May 16, 2024. Accessed May 16, 2024. https://www.prnewswire.com/news-releases/lindus-health-announces-cosmetics-clinical-trial-with-acinonyx-bio-to-evaluate-an-alternative-to-benzoyl-peroxide-for-inflammatory-acne-302146936.html
2. Andrus E, Bader K. Benzene found in various acne products; Valisure files petition with FDA to recall treatments. Dermatology Times. March 6, 2024. Accessed May 16, 2024. https://www.dermatologytimes.com/view/breaking-news-benzene-found-in-various-acne-products-valisure-files-petition-with-fda-to-recall-treatments
3. Bader K. Benzene found in benzoyl peroxide-containing acne products: what comes next? Dermatology Times. April 10, 2024. Accessed May 16, 2024. https://www.dermatologytimes.com/view/benzene-found-in-benzoyl-peroxide-containing-acne-products-what-comes-next-