#Scinai Immunotherapeutics #Israel #Jerusalem #PC111 #Pemphigus

Introduction to PC111

Scinai Immunotherapeutics Ltd., listed on Nasdaq (SCNI), has made significant strides in the treatment of autoimmune skin diseases with the announcement of a new peer-reviewed publication. This research supports the use of PC111, a groundbreaking therapy offering potential disease-modifying effects for conditions like pemphigus and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN). Dr. Roberta Lotti and her collaborators from the University of Modena contributed to this vital publication featured in the Journal of Dermatological Treatment, enhancing understanding of PC111's abilities.

Background of the Research

The publication, titled "Treatment of pemphigus and other neglected skin conditions with PC111 a human anti-Fas Ligand monoclonal antibody a potential disease modifier," builds on previous award-winning research by Dr. Lotti, who, in June 2023, was honored with the 'Oscar of Italian Dermatology.' In this research, PC111 was shown to successfully prevent blistering in humanized models of pemphigus by targeting soluble Fas Ligand (sFasL), a significant factor implicated in keratinocyte apoptosis and acantholysis. Through this mechanism, PC111 aims to offer a more tailored treatment for patients suffering from these debilitating conditions.

Scientific Validation

The recent findings link new data from proprietary humanized FasL mouse models, revealing that treatment with PC111 led to a notable decrease in disease activity. Unlike traditional treatments that dampen the entire immune response, PC111 operates locally at the keratinocyte level, demonstrating a unique and non-immunosuppressive method of action crucial for safety and efficacy. As the study highlights, this approach is particularly important for life-threatening dermatological conditions such as SJS/TEN, where early intervention is vital.

Addressing Unmet Medical Needs

Current therapies for pemphigus and SJS/TEN have relied on systemic immunosuppression methods, such as corticosteroids and Rituximab. These treatments often exhibit slow response times and carry serious side effects, necessitating alternatives. Experimental therapies, including BTK inhibitors and FcRn inhibitors, have struggled during late-stage development, further emphasizing the demand for innovative treatments.

PC111's mechanism of action, which targets the terminal step in the disease pathway rather than suppressing the immune system, could potentially offer a faster and safer therapeutic alternative. The estimated market for these indications could surpass one billion dollars annually, spotlighting the economic significance of this innovation.

Development Path and Future Outlook

Scinai aims to advance PC111 through Phase 1 clinical trials following IND-enabling studies, contingent upon its option to acquire Pincell Srl, the company behind pivotal research. With orphan drug designation already granted in the EU, Scinai plans to seek similar status in the U.S., which would bolster its efforts to streamline a faster route to market, expected within three to four years.

Key Leadership and Evidential Support

The leadership behind the PC111 initiative includes renowned experts, notably Prof. Carlo Pincelli and Dr. Antonino Amato of Pincell Srl, alongside Dr. Roberta Lotti and Dr. Brydon Bennett. Their robust professional background, coupled with guidance from Scinai's Scientific Advisory Board, positions the program for success through both scientific rigor and strategic foresight.

The strength of PC111 is reinforced by various peer-reviewed publications, including distinctions for the previous 2023 research and the current 2025 findings, fostering confidence in its potential. Additionally, Scinai benefits from potential non-dilutive funding, which may cover a significant portion of its development costs through grants aimed at achieving IND readiness.

CEO Insights

Amir Reichman, CEO of Scinai, emphasized the essential nature of this research, stating, "This new publication further validates our conviction that PC111 has the potential to transform the treatment landscape for pemphigus and SJS/TEN." The combination of sound scientific evidence, a clear regulatory path, and substantial market opportunity positions PC111 as a promising asset for both patients and shareholders.

Conclusion

The publication of this new research on PC111 marks a key milestone for Scinai Immunotherapeutics and underscores the potential for innovative therapies to significantly impact the treatment landscape for autoimmune skin diseases. As clinical trials progress, the medical community remains hopeful for the introduction of safer, more effective treatment options for pemphigus and SJS/TEN, addressing long-standing unmet medical needs with the promise of improved patient outcomes.