Lyfaquin®, a first-in-class resuscitative agent for patients with excessive blood loss, to be launched in India
WILLOWBROOK, Ill., July 20, 2020 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, announced that it has successfully received marketing authorization and is preparing to launch Lyfaquin® (centhaquine), a novel resuscitative agent indicated for the treatment of patients with hypovolemic shock as a frontline adjuvant to standard of care. The company plans to make Lyfaquin® available to patients by the middle of September 2020.
Over five decades numerous unsuccessful attempts have been made to develop an effective resuscitative agent. Several agents that could decrease metabolic activity to reduce oxygen demand were studied, however this hibernation-based approach has not shown any promise clinically. Hemoglobin-based blood substitutes were prepared as resuscitative agents, but none has been successful to get market authorization. Crystalloids, colloids and blood products are still the main products used for resuscitation.
Lyfaquin® increases blood pressure and cardiac output by augmenting venous blood return to the heart (alpha-2B adrenergic stimulation) and enhancing tissue blood perfusion by arterial dilatation (sympatholytic function due to central alpha-2A adrenergic stimulation). Enhancing tissue blood perfusion is a significant advantage in reducing the needed volume of resuscitation fluid and preventing fluid extravasation and lung edema. Lyfaquin® does not act on beta-adrenergic receptors, therefore mitigating the risk of arrhythmia.
Lyfaquin® is likely to be a transformational therapy for hypovolemic shock because it addresses key drivers of mortality. A pivotal phase III study of Lyfaquin® in hypovolemic shock demonstrated transformational improvement over standard of care in increasing blood pressure and reducing blood lactate levels, both of which are key measures of improving blood flow and increasing organ blood perfusion. Proportion of MODS patients with ≥60% of their hospital stay in the ICU were 35.48% in the Lyfaquin® group compared to 53.33% in control. Acute Respiratory Distress Syndrome (ARDS) measures were compared between day 1 (before resuscitation) and day 3 (post-resuscitation). In control patients receiving standard of care the difference between means was 0.04839 ± 0.05696 (P=0.4023). In the Lyfaquin® treated group the ARDS difference between means was 0.1065 ± 0.04464 (P=0.0202). Multiple Organ Dysfunction Score (MODS) measures were compared between day 3 and day 7 of resuscitation. There was no improvement in MODS in the control group (difference between means was 0.00 ± 0.2697 (P>0.999)), whereas the Lyfaquin® group showed significant improvement (difference between means was 0.9091 ± 0.1964 (P=0.0001)). Lyfaquin® treatment thus significantly decreased both ARDS and MODS compared to standard of care alone. In a 105 patient phase III study (NCT04045327), a significant (P=0.0371) reduction in 28-day mortality was observed in the Lyfaquin® group compared to standard of care.
Lyfaquin® is a front-line therapy to be used in conjunction with standard of care and is well positioned to address key unmet needs in hypovolemic shock. Lyfaquin® is well tolerated, with no serious adverse events attributed to Lyfaquin®. Pharmazz is working with regulatory agencies in India to make Lyfaquin® available to patients.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company's website, www.pharmazz.com.
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties including the risk that Pharmazz, Inc. cannot execute its business plan for lack of capital or other resources, distribution, partnering or licensing/acquisition opportunities. Actual events or results may differ materially from those projected in any of such statements due to various factors. Any of these risks could cause Pharmazz, Inc. or its industry's, actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this presentation. Except as required by applicable law Pharmazz, Inc. does not intend to update any of the forward-looking statements to conform these statements to actual results.
SOURCE Pharmazz, Inc.