Midazolam Hydrochloride

JENA, Germany, April 09, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced new in vitro findings demonstrating that izicopan does not exhibit time-dependent inhibition of CYP3A4, an important indicator for the risk for drug-drug interactions (DDIs) and liver toxicity. These results further support izicopan’s potential as a differentiated, best-in-class oral C5a receptor (C5aR) inhibitor. To build upon previous CYP interaction data for izicopan, which showed only marginal inhibition of CYP3A4 (IC₅₀ = 62 µM) in a time-dependent inhibition (TDI) IC₅₀ shift assay, InflaRx conducted a mechanistically informative Ki-based TDI (Ki/Kinact) study. While TDI shift assays serve as rapid screening tools to identify potential time-dependent inhibition, Ki/Kinact studies provide a more definitive and quantitative assessment, enabling a reliable determination of the presence or absence of time-dependent inhibition. The Ki-based TDI study confirms that izicopan does not inhibit CYP3A4 (IC₅₀ > 100 µM) and exhibits no time-dependent inhibition up to the highest tested concentration (100 µM), supporting a low risk of clinically relevant DDIs. Using two probe substrates, midazolam (MDZ) and testosterone (TES), no evidence of CYP3A4 time-dependent inhibition was observed, providing mechanistic confirmation of izicopan’s favorable pharmacological profile. This feature is particularly important, as time-dependent CYP3A4 inhibition can result in DDIs, hepatotoxicity, or reduced metabolism of concomitant medications such as corticosteroids. Prof. Renfeng Guo, Chief Scientific Officer and Founder of InflaRx , commented: “These new mechanistic data highlight izicopan’s differentiated pharmacological profile, demonstrating no CYP3A4 time-dependent inhibition even at high concentrations. Combined with its favorable metabolic stability and human PK/PD profile, izicopan has the potential to minimize drug–drug interaction and liver toxicity risks, offering significant benefits for patients across multiple inflammatory diseases.” About izicopan Izicopan is an orally administered, small molecule inhibitor of the C5a receptor C5aR1 that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan does not inhibit the cytochrome P450 3A4 (CYP3A4) enzyme, which plays an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that izicopan was well tolerated in treated subjects and exhibited no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of izicopan, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety pro izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7). About InflaRx N.V. InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx‘s lead program is izicopan, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The Company is developing izicopan for the treatment of several inflammatory diseases, including hidradenitis suppurativa. InflaRx also has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). Contacts: InflaRx N.V. MC Services AG Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the success of our future clinical trials for vilobelimab's treatment of other debilitating or life-threatening inflammatory indications, including acute respiratory distress syndrome, or ARDS; potential strategic transactions or collaborations, including a potential partnership of izicopan, or vilobelimab for PG; the success of our future clinical trials for izicopan, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of vilobelimab, izicopan and any other of our product candidates and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our biologics license application submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the FDA, or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated immunological and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval or commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

Tomaso Dameno, CEO of Primex, brings over 20 years of pharmaceutical experience across manufacturing, consulting, commercial operations and strategic leadership. After roles in the industry and leading international consulting initiatives, he joined Primex in 2018 as COO. Now at the helm following former CEO Alan’s Knox’s retirement, he is guiding the Swiss specialty pharma group through its next phase, focused on innovation and global expansion. Our strategic approach emphasises local commercial partnerships to maximise regional value creation Our strategic approach emphasises local commercial partnerships to maximise regional value creation My pharmaceutical career commenced in clinical manufacturing operations over twenty years ago, initially with Pfizer before transitioning to Helsinn in Switzerland, where I gained comprehensive international exposure to active pharmaceutical ingredients. I then moved to Zambon where I gained experience in dosage forms and distribution networks. This operational foundation proved invaluable when I subsequently co-established an international consulting practice with an Italian partner, expanding our capabilities and international presence globally. The consulting experience was particularly transformative in developing my understanding of value creation. In consulting, success depends entirely on delivering measurable value rather than merely providing time and resources. This discipline taught me that clients often articulate what they want, but the true value proposition lies in understanding and delivering what they actually need. The ability to integrate rapidly into client organizations and exceed expectations became a cornerstone of my approach to business leadership. I joined Primex in 2018 as Chief Operating Officer, to support a new strategy focused on the registration and launch of Ozalin throughout Europe as part of a broader international expansion plan supported by a shareholder base interested in fuelling growth through strategic acquisitions. The transition to Chief Executive Officer occurred naturally at the end of 2023. Having served as COO for several years, managing commercial partner relationships, the succession represented a logical progression. Our business model has remained consistent over recent years, though we have significantly refined our organizational structure and operational methodologies. Rather than focusing exclusively on success narratives, I believe in acknowledging the critical role that challenges and setbacks play in organizational development. The COVID-19 pandemic created unprecedented challenges for companies of our size, with an estimated 60 percent of similar organizations either failing or being acquired under distressed circumstances. Our survival and subsequent recovery positioned us well for future growth opportunities. The pharmaceutical landscape has transformed dramatically over the past four to five years, with COVID-19 serving as a catalyst for changes that were already underway. The key strategic insight emerging from this period has been the paramount importance of focusing exclusively on what matters most. This principle, while frequently discussed in business literature, proves extraordinarily difficult to implement in practice. It requires the discipline to decline approximately 80 percent of opportunities that may appear attractive but ultimately do not contribute to core objectives, concentrating resources on the critical 20 percent that drives genuine value creation. Our recovery after the pandemic exemplifies the impact of team dynamics in small to medium-sized organizations. Unlike larger corporations with inherent inertia, smaller organizations immediately reflect the consequences of both positive contributions and negative influences. When facing situations that appeared potentially existential, particularly in 2022 and 2023, the collective commitment of our team proved strong enough to overcome these significant obstacles. Primex originated in Finland following the strategic acquisition of two branded generics from Bayer, representing what proved to be an exceptionally prescient transaction by our founders. The establishment of our Swiss entity facilitated international expansion, leveraging Switzerland’s inherent advantages in terms of regulatory environment, talent acquisition, quality standards and reputation. Our acquisition of Ozalin was another important step along our journey. The only product indicated for paediatric sedation at the time we finalized development and gained regulatory approval, Ozalin exemplified how Primex best employed our partnering, development and regulatory skills to deliver a unique, differentiated solution to children, parents and healthcare providers. The subsequent acquisition of Ogna, an Italian company specializing in dental products, added a nearly century-old brand with exceptional market recognition in endodontics. Today, Primex operates as a focused pharmaceutical group encompassing three fully integrated pharmaceutical companies: Finland serving primarily European markets, Switzerland handling international operations outside Europe, and Ogna operating domestically in Italy while expanding internationally under its own brand. Our organizational structure employs a matrix approach, enabling personnel based in Finland to contribute to Ogna or Swiss operations, and vice versa. This lean business model deliberately excludes research and development activities, with our paediatric sedation formulation project previously representing our primary development initiative. We maintain no proprietary manufacturing facilities, aligning with the industry trend toward outsourcing, which has driven the remarkable growth of contract manufacturing organizations over the past fifteen years. Our strategic approach emphasizes local commercial partnerships to maximize regional value creation, achieving synergies where the combination of Primex capabilities and local partner expertise delivers results significantly exceeding the sum of individual contributions. While our size precludes establishing legal entities globally, our partnership model has proven highly effective, though it requires careful partner selection and ongoing relationship management. Partnership development represents one of our most challenging yet crucial competencies. While due diligence processes provide valuable insights, successful partnerships require multiple complementary elements. Geographic scope proves important, particularly when partners operate across multiple territories, as this creates stronger incentives for mutual success. Size compatibility represents a critical factor often overlooked in partnership evaluation. As a smaller organization, partnerships with entities one hundred times our size often fail because our contribution becomes insignificant to their operations. Optimal partnerships occur when size differentials allow for meaningful mutual contribution to respective businesses. Beyond structural considerations, successful partnerships require genuine chemistry between organizations and alignment of business values and ethical standards. In the past, we experienced challenging situations with some partners where technical criteria appeared favourable, but fundamental differences in business values and ethical approaches created an ultimately unsustainable relationship. Interestingly, one of our most successful partnership challenges conventional wisdom. Our Mexican partner, a 30,000-person organization, would typically be considered incompatible based on size differential. However, this fifteen-year relationship has proven exceptional, likely due to product uniqueness and strong personal relationships. While this represents an exception rather than a model, it demonstrates the importance of individual circumstances in partnership success. The durability of partnerships depends significantly on corporate stability and strategic alignment. Changes in ownership, leadership, or strategic direction can rapidly alter partnership dynamics regardless of personal relationships. We have experienced situations where excellent working relationships became ineffective following corporate restructuring or strategic pivots by partner organizations. Following successful stabilization of COVID-related disruptions, we have embarked on a strategic repositioning built upon our three core assets. A significant recent achievement involved completing the European divestiture of our paediatric sedation formulation rights to a pharmaceutical company, enhancing the possibility of paediatric patients being able to benefit from this novel, approved therapy. This transaction exemplifies our strategic approach to value creation. We successfully developed, registered, and launched an innovative repurposed drug across sixteen European countries with a team of ten professionals, completing the project on schedule and without delays. This product’s success in improving paediatric patient outcomes across Europe validates our development capabilities and creates a compelling foundation for expansion into other markets. Our strategic focus now centres on the US market, where we believe significant opportunities exist for this product, followed by potential expansion into China and other strategic markets. Concurrently, we are pursuing organic growth of our intravenous anaesthesia business in additional geographies while implementing ambitious expansion plans for Ogna within Italy and Europe. Ogna’s brand strength in dental and endodontic applications positions it as the premier partner for any organization seeking to establish presence in the Italian market through a recognized brand platform. Beyond our three product platforms, our team represents our fourth strategic asset. Our collective experience enables highly effective and efficient execution, developed through diverse backgrounds and refined through challenging circumstances. We maintain rigorous financial discipline, respecting shareholder capital through strategic investment when necessary and prudent cost management when appropriate. Execution capability represents our core competence, enabling rapid decision-making and implementation. Our upcoming transition requires identifying new investors while continuing under current management direction. This process demands demonstrated value creation capability and strategic positioning for future growth. Our preferred growth strategy involves combining our current management team and company assets with new, growth-orientated investors and strategic opportunities to increase scale and critical mass. Many investors focus on opportunities above certain threshold sizes, making strategic combinations essential for accessing optimal investment partners. Our current international presence encompasses Mexico and Latin America, Southeast Asia primarily through Indonesia, and developing opportunities in the MENA region. The US and China represent our primary expansion targets, with potential future consideration of Japan. Portfolio expansion remains under active consideration, though within defined parameters. We maintain focus on hospital-based products and recently declined an ophthalmology opportunity as inconsistent with our strategic direction. Our preference excludes generic pharmaceutical opportunities, instead emphasizing branded products where we can differentiate through quality and service rather than competing solely on price. Our global expansion strategy leverages our organizational agility and partner management capabilities. Success requires placing appropriate personnel in strategic positions, combining competence, experience, and suitable mind-set for dynamic business environments. Rather than maintaining centralized operations, we prioritize finding optimal talent regardless of geographic location, supported by exceptional work-life balance and significant professional autonomy. Our organizational philosophy emphasizes results over process, offering unprecedented work-life balance coupled with substantial responsibility. This approach requires self-organization and strong ethical foundations, making it suitable for specific professional profiles rather than universal application. We prioritize talent acquisition over geographic constraints, recognizing that optimal performance occurs when professionals can balance personal and professional responsibilities effectively. This philosophy has proven instrumental in attracting and retaining international talent capable of delivering exceptional results across multiple markets simultaneously. Our hiring strategy emphasizes identifying what we do not need rather than prescriptive requirements. Professionals successful in large pharmaceutical organizations may struggle in our environment if they attempt to replicate big pharma methodologies rather than adapting to our resource-conscious, efficiency-focused approach. Primex represents a healthy, stable organization with proven capabilities in innovation and international market development and execution. Our track record demonstrates consistent delivery without the typical surprises that emerge during due diligence processes. We maintain cost discipline and operational efficiency while delivering measurable results across multiple markets. Our international experience spans decades rather than years, providing deep understanding of diverse regulatory environments and cultural considerations. Partnership reliability represents a core competency, with agreements serving as frameworks rather than constraints for ongoing collaboration. We are actively seeking partnerships for our paediatric formulation product expansion, recognizing that patients in the US and other markets deserve access to products that have demonstrated significant impact on healthcare outcomes in Europe. Similarly, Ogna’s brand strength creates opportunities for strategic partnerships with organizations seeking to leverage established market presence in Italy and Europe. Our immediate future focuses on completing strategic transitions while maintaining operational excellence. We continue hiring selectively, seeking professionals who thrive in hyper-entrepreneurial environments rather than traditional corporate structures. Compliance and integrity remain fundamental to our operations, providing the ethical foundation necessary for sustainable growth. The combination of our proven assets, experienced team, and strategic positioning creates compelling opportunities for investors and partners seeking exposure to specialty pharmaceutical markets. Our openness to strategic partnerships reflects confidence in our ability to create value through collaborative relationships.