Core Insights - Scinai Immunotherapeutics Ltd. has published new peer-reviewed research confirming the efficacy and safety of PC111, a human anti-Fas Ligand monoclonal antibody, in treating pemphigus and other skin conditions [1][2][3] Scientific and Clinical Findings - The new study validates PC111's ability to prevent blister formation in humanized models of pemphigus by targeting soluble Fas Ligand, which is crucial for keratinocyte apoptosis [2][3] - PC111 has shown significant reduction in disease activity in a proprietary humanized FasL mouse model, confirming its non-immunosuppressive action at the keratinocyte level [3] - The research also indicates PC111's potential in treating Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), a severe dermatological condition [4] Market Opportunity - Current treatments for pemphigus and SJS/TEN involve chronic immunosuppression, which can have serious side effects; PC111 offers a differentiated, fast-acting, and safer therapeutic profile [5][6] - The combined market opportunity for pemphigus and SJS/TEN is estimated to exceed one billion dollars annually [6] Development Strategy - Scinai plans to advance PC111 through IND-enabling studies and clinical development, with orphan drug designation already granted in the EU and similar status sought in the U.S. [7] - The companies are exploring accelerated approval pathways that could facilitate market entry within three to four years [7] Program Structure and Leadership - The PC111 program is led by a team of experts including Prof. Carlo Pincelli and Dr. Antonino Amato, supported by Scinai's Scientific Advisory Board [8] - The efficacy of PC111 is backed by multiple peer-reviewed publications, enhancing its credibility [8] - Scinai may receive up to 80% cost coverage through a €15 million FENG grant to support development [8] Regulatory and Strategic Outlook - The combination of orphan designation, high unmet medical need, and a well-defined mechanism of action supports a realistic path toward Breakthrough Therapy designation and/or Accelerated Approval [9]
Scinai Announces New Peer-Reviewed Publication Supporting PC111 as a Disease-Modifying Therapy for Pemphigus and SJS/TEN