InflaRx Announces Positive Topline Results from the Multiple Ascending Dose (MAD) Phase I Study with C5aR Inhibitor INF904
- INF904 demonstrated favorable pharmacokinetic and pharmacodynamic data
- INF904 achieved ≥90% blockade of C5a-induced neutrophil activation over the 14-day dosing period
- INF904 was well tolerated with no safety concerns
- InflaRx plans to advance INF904 into Phase II clinical development
- None.
Insights
The recent pharmacokinetic (PK) and pharmacodynamic (PD) data from InflaRx's Phase I trial of INF904 demonstrate a robust blockade of C5a-induced neutrophil activation, a critical factor in immune-inflammatory responses. This suggests that INF904 has a strong potential to become a leading treatment in the domain of anti-inflammatory therapeutics. The favorable safety profile, with no significant adverse events reported, positions INF904 as a viable candidate for further clinical development.
From a research perspective, the ability of INF904 to achieve and maintain therapeutic drug levels without the necessity of food intake is particularly noteworthy. This could enhance patient compliance and differentiate INF904 from other treatments that have dietary restrictions. The proportional increase in drug exposure with dosing indicates a predictable pharmacological response, which is advantageous for clinicians when tailoring treatment regimens.
As the company progresses towards Phase II clinical development, the focus will likely shift to the efficacy of INF904 in treating chronic immune-inflammatory conditions. The planned introduction of a commercially viable formulation enhances the drug's market potential. However, the upcoming pre-clinical and chronic toxicology studies will be critical to ensure long-term safety, a key concern for chronic therapies.
InflaRx's announcement regarding INF904's transition into Phase II clinical development could have a positive impact on the company's stock valuation, given the high interest in novel anti-inflammatory agents. The market for such therapeutics is substantial, with a growing prevalence of chronic inflammatory diseases driving demand for effective treatments.
The reported 90% blockade of C5a-induced neutrophil activation over a 14-day period indicates a sustained therapeutic effect, which is a strong selling point for potential investors and partnering pharmaceutical companies. Furthermore, the lack of serious adverse events suggests a favorable risk-benefit profile, potentially expediting the regulatory approval process.
Investors should monitor the outcomes of the additional pre-clinical studies and the subsequent Phase II trials. Positive results could lead to significant stock appreciation, while any setbacks might adversely affect investor sentiment. The timing of these milestones, with Phase II initiation planned for late 2024, provides a clear timeline for potential investment decisions.
The strategic planning behind INF904's clinical development appears to be methodical, with InflaRx taking a stepwise approach to ensure a solid foundation of safety data before advancing into efficacy trials. The company's decision to develop a commercially viable formulation alongside ongoing trials is a forward-thinking move that may streamline the transition from clinical development to market launch.
Selection of indications for the Phase II trials will be a pivotal decision for InflaRx. Targeting diseases with a high unmet medical need could position INF904 as a potential blockbuster drug, subject to successful trial outcomes. The company's plan to conduct both short-term and long-term dosing studies reflects a thorough understanding of the necessity to demonstrate INF904's effectiveness in both acute and chronic settings.
While the end of 2024 for Phase II initiation may seem distant, it allows time for meticulous planning and potentially increases the likelihood of successful trial outcomes. However, investors should be aware of the risks associated with clinical development, including the possibility of unforeseen safety issues or lack of efficacy in a broader patient population.
- MAD pharmacokinetic and pharmacodynamic data support best-in-class potential of INF904 over tested dose range of 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days:
- Achieved ≥
90% blockade of C5a-induced neutrophil activation over 14-day dosing period - Achieved favorable concentration-time profiles with target exposures of therapeutic potential
- Well tolerated with no safety signals of concern over entire dose range
- Achieved ≥
- Company to advance INF904 into Phase II clinical development
- Company to host a conference call today, January 4, 2024 at 8:30 a.m. EST/14:30 CET
JENA, Germany, Jan. 04, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced today topline results from the multiple ascending dose (MAD) part of its randomized, double-blind, placebo-controlled Phase I trial for INF904, an orally administered low molecular weight C5aR inhibitor. The pharmacokinetic (PK) and pharmacodynamic (PD) parameters confirm the favorable data InflaRx reported recently from the single ascending dose (SAD) part of the study, which provides support for the best-in-class potential of this drug candidate. INF904 was well tolerated and there were no adverse safety events of concern after repeated dosing in participants over the entire tested dose range.
In the MAD part of the randomized, double-blind, placebo-controlled Phase I trial, 24 participants received multiple doses of INF904 for 14 days of either 30 mg once per day (QD), 30 mg twice per day (BID) or 90 mg BID. The study’s primary objective was to evaluate the safety and tolerability of repeated dosing. Several PK parameters were analyzed as secondary endpoints, and the effect of the dosing scheme on C5a-induced neutrophil activation in blood samples from the participants was also explored in an ex vivo assay.
“We are very pleased that the MAD part of the Phase I study exceeded the already compelling results from the SAD part of the study. The PK and PD profiles suggest that INF904 allows for highly effective inhibition of the C5a/C5aR pathway and that INF904 should enable consistent control of C5aR signaling in patients. In addition, we have the potential to apply a broad dose range up to high doses for the planned development of INF904 in chronic immune-inflammatory conditions,” said Camilla Chong, MD, Chief Medical Officer of InflaRx. “We are excited to advance this highly promising oral C5aR inhibitor into Phase II clinical development.”
The safety analysis of INF904 in the MAD part of the Phase I study demonstrated that it was well tolerated in participants over the entire dose range and resulted in no safety signals of concern. The overall percentage of adverse events (AEs) in INF904 treated participants was
Analysis of the PK profile showed that potential target AUC0-12h, Cmax, and trough values were achieved rapidly within 14 days of 30 mg BID dosing. INF904 exposure further increased proportionally with dosing up to 90 mg BID. These results were demonstrated even when participants ingested the drug in a fasted state, suggesting that food is not required to achieve potentially therapeutic drug levels.
Analysis of the PD profile showed that the blocking activity of C5a-induced neutrophil activation by INF904 reached equal to or above
InflaRx previously reported the data from the SAD part of the trial with 62 healthy volunteers in a press release and conference call. The SAD part showed a favorable dose-proportional systemic exposure with desired blocking activity (>
In parallel, InflaRx has progressed with the development of a commercially viable formulation of INF904 which the Company plans to introduce into Phase II development towards the end of 2024.
InflaRx is currently conducting additional required pre-clinical studies, including long-term chronic toxicology studies, to enable longer-term dosing of INF904 for chronic inflammatory diseases. InflaRx currently plans to initiate a short-term dosing Phase II study towards the end of 2024, followed by a longer-term dosing Phase II study in 2025. Further details of this clinical development plan with selection of indications will be announced in due course.
Conference call scheduled for today, January 4, 2024
InflaRx will host a conference call today, January 4, 2024 at 8:30 a.m. EST (14:30 CET) to provide more details about the announced topline results of the MAD part of its Phase I study of INF904 in healthy human subjects. To participate in the conference call, participants may pre-register here and will receive a dedicated link and dial-in details to easily and quickly access the call. A replay will be available on the InflaRx website in the Investors – Events & Presentations section after the live conference call has concluded.
InflaRx’s management team will host investor and business meetings during JPM Week from January 8 to 11, 2024 in San Francisco, California.
About INF904
INF904 is an orally administered small molecule inhibitor of C5a-induced signaling via the receptor C5aR. INF904 showed anti-inflammatory therapeutic effects in several pre-clinical disease models. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play 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 INF904 is well tolerated in treated subjects and exhibits 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 (QD) to 90 mg twice per day (BID) for 14 days. Pharmacokinetic / pharmacodynamic data support best-in-class potential of INF904 with a ≥
About InflaRx
InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
InflaRx (Nasdaq: IFRX) is a biotechnology 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 product candidate, vilobelimab, is 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 in different indications. 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 www.inflarx.com.
Contacts
| InflaRx N.V. | MC Services AG |
| 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 receptiveness of Gohibic (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendations by medical/healthcare institutes and other third-party organizations, our ability to successfully commercialize and the receptiveness of Gohibic (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of Gohibic (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under an Emergency Use Authorization and in the future if approved for commercial use in the United States or elsewhere; the success of our future clinical trials for vilobelimab’s treatment of COVID-19 and other debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum, and any other product candidates, including INF904, 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 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 Marketing Authorization Application submission for vilobelimab and 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 U.S. Food and Drug Administration, the European Medicines Agency 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 expectations regarding the scope of any approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab 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 and 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 U.S. Securities and Exchange Commission. 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.
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