A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVENOUS ICLAPRIM VERSUS VANCOMYCIN IN THE TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS SUSPECTED OR CONFIRMED TO BE DUE TO GRAM-POSITIVE PATHOGENS. REVIVE-1

Start Date16 Jun 2016

Sponsor / Collaborator

Motif BioSciences, Inc.

NCT02600611

/ CompletedPhase 3

A Phase 3, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of ABSSSI: REVIVE-1

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

Start Date01 Nov 2015

Sponsor / Collaborator

Motif Bio Plc

NCT02607618

/ CompletedPhase 3

A Phase 3, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of ABSSSI: REVIVE-2

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

Start Date01 Nov 2015

Sponsor / Collaborator

Motif Bio Plc

100 Clinical Results associated with Iclaprim

100 Translational Medicine associated with Iclaprim

100 Patents (Medical) associated with Iclaprim

122

Literatures (Medical) associated with Iclaprim

01 Dec 2024·Bioactive Materials

Unravelling the physicochemical and antimicrobial mechanisms of human serum albumin/tannic acid coatings for medical-grade polycaprolactone scaffolds

Article

Author: Cometta, Silvia ; Donose, Bogdan C. ; Dargaville, Tim R ; Juárez-Saldivar, Alfredo ; Rakić, Aleksandar D ; Dargaville, Tim R. ; Hutmacher, Dietmar W ; Donose, Bogdan C ; Ravichandran, Akhilandeshwari ; Hutmacher, Dietmar W. ; Xu, Yanan ; Bock, Nathalie ; Rakić, Aleksandar D.

Biofilm-related biomaterial infections are notoriously challenging to treat and can lead to chronic infection and persisting inflammation. To date, a large body of research can be reviewed for coatings which potentially prevent bacterial infection while promoting implant integration. Yet only a very small number has been translated from bench to bedside. This study provides an in-depth analysis of the stability, antibacterial mechanism, and biocompatibility of medical grade polycaprolactone (mPCL), coated with human serum albumin (HSA), the most abundant protein in blood plasma, and tannic acid (TA), a natural polyphenol with antibacterial properties. Molecular docking studies demonstrated that HSA and TA interact mainly through hydrogen-bonding, ionic and hydrophobic interactions, leading to smooth and regular assemblies. In vitro bacteria adhesion testing showed that coated scaffolds maintained their antimicrobial properties over 3 days by significantly reducing S. aureus colonization and biofilm formation. Notably, amplitude modulation-frequency modulation (AMFM) based viscoelasticity mapping and transmission electron microscopy (TEM) data suggested that HSA/TA-coatings cause morphological and mechanical changes on the outer cell membrane of S. aureus leading to membrane disruption and cell death while proving non-toxic to human primary cells. These results support this antibiotic-free approach as an effective and biocompatible strategy to prevent biofilm-related biomaterial infections.

01 Dec 2024·APPLIED MICROBIOLOGY AND BIOTECHNOLOGY

Anti-virulence potential of iclaprim, a novel folic acid synthesis inhibitor, against Staphylococcus aureus

Article

Author: Yang, Han ; Liu, Qingzhong ; Zhou, Jingwen ; Shu, Wen ; Song, Haoyue ; Hao, Lingyun ; He, Chunyan

Abstract:

Infections caused by Staphylococcus aureus pose a significant global public problem. Therefore, new antibiotics and therapeutic strategies are needed to combat this pathogen. This investigation delves into the effects of iclaprim, a newly discovered inhibitor of folic acid synthesis, on S. aureus virulence. The phenotypic and genotypic effects of iclaprim were thoroughly examined in relation to virulence factors, biofilm formation, and dispersal, as well as partial virulence-encoding genes associated with exoproteins, adherence, and regulation in S. aureus MW2, N315, and ATCC 25923. Then, the in vivo effectiveness of iclaprim on S. aureus pathogenicity was explored by a Galleria mellonella larvae infection model. The use of iclaprim at sub-inhibitory concentrations (sub-MICs) resulted in a reduction of α-hemolysin (Hla) production and a differential effect on the activity of coagulase in S. aureus strains. The results of biofilm formation and eradication assay showed that iclaprim was highly effective in depolymerizing the mature biofilm of S. aureus strains at concentrations of 1 MIC or greater, however, inhibited the biofilm-forming ability of only strains N315 and ATCC 25923 at sub-MICs. Interestingly, treatment of strains with sub-MICs of iclaprim resulted in significant stimulation or suppression of most virulence-encoding genes expression. Iclaprim did not affect the production of δ-hemolysin or staphylococcal protein A (SpA), nor did it impact the total activity of proteases, nucleases, and lipases. In vivo testing showed that sub-MICs of iclaprim significantly improves infected larvae survival. The present study offered valuable insights towards a better understating of the influence of iclaprim on different strains of S. aureus. The findings suggest that iclaprim may have potential as an anti-virulence and antibiofilm agent, thus potentially mitigating the pathogenicity of S. aureus and improving clinical outcomes associated with infections caused by this pathogen.

Key points:

• Iclaprim effectively inhibits α-hemolysin production and biofilm formation in a strain-dependent manner and was an excellent depolymerizing agent of mature biofilm• Iclaprim affected the mRNA expression of virulence-encoding genes associated with exoproteins, adherence, and regulation• In vivo study in G. mellonella larvae challenged with S. aureus exhibited that iclaprim improves larvae survival

10 Jan 2024·Antimicrobial agents and chemotherapy

Pharmacological validation of dihydrofolate reductase as a drug target in Mycobacterium abscessus

Article

Author: Dartois, Véronique A. ; Negatu, Dereje A. ; Aragaw, Wassihun Wedajo ; Nickbarg, Elliott B. ; Olsen, David B. ; Marrouni, Abdellatif El ; Warrass, Ralf ; Bungard, Christopher J. ; Dick, Thomas

ABSTRACT:

The Mycobacterium abscessus drug development pipeline is poorly populated, with particularly few validated target-lead couples to initiate de novo drug discovery. Trimethoprim, an inhibitor of dihydrofolate reductase (DHFR) used for the treatment of a range of bacterial infections, is not active against M. abscessus . Thus, evidence that M. abscessus DHFR is vulnerable to pharmacological intervention with a small molecule inhibitor is lacking. Here, we show that the pyrrolo-quinazoline PQD-1, previously identified as a DHFR inhibitor active against Mycobacterium tuberculosis , exerts whole cell activity against M. abscessus . Enzyme inhibition studies showed that PQD-1, in contrast to trimethoprim, is a potent inhibitor of M. abscessus DHFR and over-expression of DHFR causes resistance to PQD-1, providing biochemical and genetic evidence that DHFR is a vulnerable target and mediates PQD-1’s growth inhibitory activity in M. abscessus . As observed in M. tuberculosis , PQD-1 resistant mutations mapped to the folate pathway enzyme thymidylate synthase (TYMS) ThyA. Like trimethoprim in other bacteria, PQD-1 synergizes with the dihydropteroate synthase (DHPS) inhibitor sulfamethoxazole (SMX), offering an opportunity to exploit the successful dual inhibition of the folate pathway and develop similarly potent combinations against M. abscessus . PQD-1 is active against subspecies of M. abscessus and a panel of clinical isolates, providing epidemiological validation of the target-lead couple. Leveraging a series of PQD-1 analogs, we have demonstrated a dynamic structure-activity relationship (SAR). Collectively, the results identify M. abscessus DHFR as an attractive target and PQD-1 as a chemical starting point for the discovery of novel drugs and drug combinations that target the folate pathway in M. abscessus .

News (Medical) associated with Iclaprim

25 Jan 2023

·www.biospace.com

Methicillin-Resistant Staphylococcus aureus Infection Pipeline Clinical Trials Featuring 25+ companies

New York, USA, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Methicillin-Resistant Staphylococcus aureus Infection Pipeline Clinical Trials Featuring 25+ companies| DelveInsight Methicillin-resistant Staphylococcus aureus (MRSA) is an infection caused by antibiotic-resistant strains of the pathogen Staphylococcus aureus. Rising incidence of Methicillin-resistant Staphylococcus aureus (MRSA) infections is creating health concerns among the population. Manufacturers are focusing on product development and launches for the treatment of Methicillin-resistant Staphylococcus aureus (MRSA). DelveInsight’s 'Methicillin-Resistant Staphylococcus aureus Infection Pipeline Insight 2023' report provides comprehensive global coverage of available, marketed, and pipeline methicillin-resistant Staphylococcusaureus infection therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the methicillin-resistant Staphylococcusaureus infection pipeline domain. Key Takeaways from the Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report DelveInsight’s methicillin-resistant Staphylococcusaureus infection pipeline report depicts a robust space with 25+ companies and 28+ pipeline drugs for methicillin-resistant Staphylococcusaureus infection treatment. Key methicillin-resistant Staphylococcusaureus infection companies include Trellis Bioscience, LegoChem Biosciences, Aptorum Group, ContraFect, Crystalgenomics, Cellics Therapeutics, MicuRx, Oxford Antibiotic Group, Destiny Pharma, TSRL, Inc., TAXIS Pharmaceuticals, Basilea Pharmaceutica, Helperby Therapeutics, Akagera Medicines, Histogen, Alphamab Co. Ltd, Biocidium Pharmaceuticals, and others are evaluating novel methicillin-resistant Staphylococcusaureus infection drugs candidate to improve the treatment landscape. Promising methicillin-resistant Staphylococcusaureus infection pipeline therapies in various stages of development include TRL1068, Delpazolid, ALS 4, Teicoplanin inhalation, CG 400549, SAAP 148, Exebacase, Marinus, CTI 005, Iclaprim, MRX 4, MRX 7, XF-73, TXA709, ARV-1801, ACX-375C, ABX-605, IBT-V02, BCM-0184, Contezolid, TetramOX, Ceftobiprole, HY-004B8b, HY-005B8a, CG-549, Emricasan, KN043, and several others. Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole, is a cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. This includes methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp. In October 2022, Basilea Pharmaceutica announced the results from Phase III ERADICATE study, evaluating ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus. Results for the primary efficacy outcomes were consistent in key subgroups including in patients with MSSA or MRSA bloodstream infections at baseline, and in various categories of underlying conditions such as skin and skin structure infections, abdominal abscesses, chronic dialysis, septic arthritis, osteomyelitis, definite right-sided infective endocarditis and in patients with persistent SAB. Basilea also planned to submit a New Drug Application (NDA) for ceftobiprole to the US Food and Drug Administration (FDA) around year-end 2022. Exebacase (CF-301) being developed by ContraFect Corporation is a lysin with potent activity against Staphylococcus aureus ("Staph aureus"). Exebacase has the potential to be the first-in-class of a new treatment for patients with Staph aureus bacteremia. The FDA has granted Breakthrough Therapy designation to exebacase for the treatment of MRSA bloodstream infections (bacteremia), including right-sided endocarditis, when used in addition to SOC antistaphylococcal antibiotics in adult patients, based on the final data from the Phase II superiority trial of exebacase. In July 2022, Destiny Pharma plc announced that it had received an award from the Cystic Fibrosis Foundation. The research project will establish the potential of the Company’s proprietary XF-73 drug as a novel treatment for cystic fibrosis patients infected with methicillin-resistant Staphylococcus aureus (MRSA). CTI-005 is for the treatment of Methicillin Resistance Staphylococcus Aureus (MRSA) Pneumonia and has been granted IND allowance from the US FDA. The potent RBC-NS has the membrane lipids and receptors that a normal red blood cell has, however, the high surface-volume ratio of the RBC-NS allows it to act as a decoy. This characteristic allows the RBC-NS to bind and neutralize toxins, auto-antibodies, and bacterial infections. The pore-forming toxins emitted by MRSA can be effectively absorbed and neutralized by RBC-NS. Request a sample and discover the recent advances in methicillin-resistant Staphylococcusaureus infection treatment drugs @ Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report The methicillin-resistant Staphylococcusaureus infection pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage methicillin-resistant Staphylococcusaureus infection products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the methicillin-resistant Staphylococcusaureus infection pipeline landscape. Methicillin-Resistant Staphylococcus aureus Infection Overview Methicillin-resistant Staphylococcus aureus (MRSA) infections are caused by bacteria that have attained resistance from several antibiotics that treat diseases caused by Staphylococcus bacteria. The common patients of Methicillin-resistant Staphylococcus aureus (MRSA) infections are patients that have been in hospitals or healthcare settings for a long duration where the bacteria is found commonly. MRSA infections are known as healthcare-associated MRSA (HA-MRSA) if infected in hospitals. Such infections can spread to healthcare workers through invasive procedures, which are further transmitted to several patients by touching and operating with bare hands. Other MRSA infections occur in a considerable population of healthy people. People associated with community-associated MRSA (CA-MRSA) show symptoms appearing as painful skin boils. It further spreads through physical contact between individuals. The population at higher risk includes people surrounded by a significant number of people and childcare workers. MRSA infections might look like red bumps, pimples, or spider bites, accompanied by pus and fever. Find out more about methicillin-resistant Staphylococcusaureus infection treatment drugs @ Drugs for Methicillin-Resistant Staphylococcus aureus Infection Treatment A snapshot of the Methicillin-Resistant Staphylococcus aureus Infection pipeline drugs mentioned in the report: Drug Company Phase MoA RoA Ceftobiprole Basilea Pharmaceutica Phase III Cell wall inhibitors; Peptidyltransferase inhibitors Intravenous CG 549 CrystalGenomics Phase II Enoyl-ACP reductase inhibitors; Fatty acid synthase expression inhibitors; Fatty acid synthetase complex inhibitors Oral BCM-0184 Biocidium Pharmaceuticals Phase I NA Oral/Topical TRL1068 Trellis Bioscience Phase I Bacterial biofilm inhibitors Intravenous ALS 4 Aptorum Group Phase I Bacterial virulence inhibitors Oral EVX-B1 Evaxion Biotech Preclinical Immunostimulants NA Emricasan Histogen Preclinical Apoptosis inhibitors; Caspase inhibitors NA TarO inhibitor Prokaryotics Discovery Cell membrane inhibitors; Cell wall inhibitors NA Learn more about the emerging methicillin-resistant Staphylococcusaureus infection pipeline therapies @ Methicillin-Resistant Staphylococcus aureus Infection Clinical Trials Methicillin-Resistant Staphylococcus aureus Infection Therapeutics Assessment The methicillin-resistant Staphylococcus aureus infection pipeline report proffers an integral view of methicillin-resistant Staphylococcusaureus infection emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Pre-clinical, Discovery, Discontinued, Inactive, Phase I, Phase II, Phase III Therapeutics AssessmentBy Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical. Therapeutics AssessmentBy Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics AssessmentBy Mechanism of Action: Cell wall inhibitors; Peptidyltransferase inhibitors, Enoyl-ACP reductase inhibitors; Fatty acid synthase expression inhibitors; Fatty acid synthetase complex inhibitors, Bacterial biofilm inhibitors, Bacterial virulence inhibitors, Immunostimulants, Apoptosis inhibitors; Caspase inhibitors, Cell membrane inhibitors; Cell wall inhibitors Key Methicillin-Resistant Staphylococcus aureus Infection Companies: Trellis Bioscience, LegoChem Biosciences, Aptorum Group, ContraFect, Crystalgenomics, Cellics Therapeutics, MicuRx, Oxford Antibiotic Group, Destiny Pharma, TSRL, Inc., TAXIS Pharmaceuticals, Basilea Pharmaceutica, Helperby Therapeutics, Akagera Medicines, Histogen, Alphamab Co. Ltd, Biocidium Pharmaceuticals, and others. Key Methicillin-Resistant Staphylococcus aureus Infection Pipeline Therapies: TRL1068, Delpazolid, ALS 4, Teicoplanin inhalation, CG 400549, SAAP 148, Exebacase, Marinus, CTI 005, Iclaprim, MRX 4, MRX 7, XF-73, TXA709, ARV-1801, ACX-375C, ABX-605, IBT-V02, BCM-0184, Contezolid, TetramOX, Ceftobiprole, HY-004B8b, HY-005B8a, CG-549, Emricasan, KN043, and others. Dive deep into rich insights for new drugs for methicillin-resistant Staphylococcusaureus infection treatment; visit @ Methicillin-Resistant Staphylococcus aureus Infection Drugs Table of Contents 1. Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report Introduction 2. Methicillin-Resistant Staphylococcus aureus Infection Pipeline Report Executive Summary 3. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. Methicillin-Resistant Staphylococcus aureus Infection Pipeline Therapeutics 6. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Late Stage Products (Pre-registration) 7. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Late Stage Products (Phase III) 7.1 Ceftobiprole: Basilea Pharmaceutica 8. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Mid Stage Products (Phase II) 8.1 CG549: CrystalGenomics 9. Methicillin-Resistant Staphylococcus aureus Infection Pipeline: Early Stage Products (Phase I) 9.1 TRL1068: Trellis Bioscience 10. Methicillin-Resistant Staphylococcus aureus Infection Pipeline Therapeutics Assessment 11. Inactive Products in the Methicillin-Resistant Staphylococcus aureus Infection Pipeline 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Key Companies 14. Key Products in the Methicillin-Resistant Staphylococcus aureus Infection Pipeline 15. Unmet Needs 16. Market Drivers and Barriers 17. Future Perspectives and Conclusion 18. Analyst Views 19. Appendix For further information on the methicillin-resistant Staphylococcusaureus infection pipeline therapeutics, reach out @ Methicillin-Resistant Staphylococcus aureus Infection Treatment Drugs Related Reports Methicillin-Resistant Staphylococcus aureus Epidemiology Forecast Methicillin-Resistant Staphylococcus aureus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the methicillin-resistant Staphylococcusaureus epidemiology trends. Methicillin-Resistant Staphylococcus aureus Infection Market Methicillin-Resistant Staphylococcus aureus Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key methicillin-resistant Staphylococcusaureus infection companies, including Trellis Bioscience, LegoChem Biosciences, Aptorum Group, Allergan, iNtRON Biotechnology, Neupharma, ImmuPharma, Lytix Biopharma, CrystalGenomics, AIMM Therapeutics, among others. Staphylococcus aureus Bacteremia Pipeline Staphylococcus aureus Bacteremia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug pro including clinical and non-clinical stage products, and the key Staphylococcus aureus Bacteremia companies, including ContraFect, Armata Pharmaceuticals, iNtRON Biotechnology, Durata Therapeutics, Cipher Pharmaceuticals, XBiotech, Basilea Pharmaceutica, Genentech, among others. Hospital Acquired Methicillin-Resistant Staphylococcus aureus Infections Pipeline Hospital Acquired Methicillin-Resistant Staphylococcus aureus Infections Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug pro including clinical and non-clinical stage products, and the key Hospital Acquired Methicillin-Resistant Staphylococcus aureus Infections companies, including Trellis Bioscience, LegoChem Biosciences, Aptorum Group, Allergan, iNtRON Biotechnology, Neupharma, ImmuPharma, Lytix Biopharma, CrystalGenomics, AIMM Therapeutics, among others. Other Trending Reports Treatment Resistant Depression Market | Advanced Renal Cell Carcinoma Market | Brain Cancer Market | Centronuclear Myopathy Market | Head And Neck Squamous Cell Carcinoma Market | Acquired Immunodeficiency Syndrome Market | Acute Intermittent Porphyria Market | Neurovascular Devices Market | Defibrillators Market | Ventricular Hypertrophy Market | Urolithiasis Market | Alopecia Areata Market | Autonomic Dysfunction Market | Acute Ischemic Stroke Ais Market | Adenoid Cystic Carcinoma Market | Aspergillosis Market | Biliary Atresia Market | Biliary Tumor Market | Chronic Inducible Urticaria Market | Chronic Insomnia Market | Critical Limb Ischemia Market | Endometriosis Pain Market | Generalized Anxiety Disorder Gad Market | Hallux Valgus Market | Hemophilia B Market | Immunologic Deficiency Syndrome Market | Neuroblastoma Market | Neuromodulation Devices Market | Neurovascular Thrombectomy Devices Market | Osteosarcoma Market | Pemphigus Vulgaris Market | Progressive Familial Intrahepatic Cholestasis Market | Pruritus Market | Radiation Toxicity Market | Pulmonary Hypertension Associated With Interstitial Lung Disease Market | Cluster Headaches Market | Foot And Ankle Devices Market | Intravenous Immunoglobulin Market | Bile Duct Neoplasm Market | Blood Glucose Monitoring Systems Market | Rett Syndrome Market | Tissue Heart Valves Market | Cardiac Biomarkers Testing Devices Market | Subscription Healthcare | Hepatorenal Syndrome Market | Central Venous Catheters Market | Continuous Renal Replacement Therapy Machines Market | Nonalcoholic Steatohepatitis Market | Necrotizing Enterocolitis Market | Cardiac Amyloidosis Market | Artificial Iris Market | Aortic Aneurysm Stent Grafts Market | Polypoidal Choroidal Vasculopathy Market | Adrenal Crisis Market | Hearing Implants Market | Image Guided Surgery Devices Market | Angioedema Market | Bladder Cancer Market Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us atLinkedIn Contact Us Shruti Thakur info@delveinsight.com +1(919)321-6187

Phase 3Phase 2Clinical Result

10 Jan 2021

·www.biospace.com

BIOMARCK Appoints Graham Lumsden as President and Chief Executive Officer

“We are pleased to welcome Graham to Biomarck. He brings a wealth of experience in pharmaceuticals and biotechnology to this company as we initiate the next phase of clinical trials in 2021,” said Rajin Ahuja, Executive Chairman of Biomarck. “Graham is the right leader at the right time to advance our clinical programs in Acute Respiratory Distress Syndrome (ARDS), Chronic Obstructive Pulmonary Disease (COPD) and Non-Small Cell Lung Cancer (NSCLC), together with the other assets in our portfolio, in 2021 and beyond.” Before joining Biomarck, Dr. Lumsden served as CEO of Motif Bio where he raised $125 million, including two IPOs (AIM and NASDAQ), to advance iclaprim, a targeted antibacterial, through Phase 3 and NDA submission. Prior to Motif, he founded and was the CEO of Tiemed LLC, a biotech company developing solutions for patients with difficulties taking oral medicines. Dr. Lumsden also spent over 20 years at Merck & Co., Inc., where he gained global expertise in both veterinary and human health, including worldwide businesses at Merck with annual revenues of more than $1 billion. Dr. Lumsden brings extensive domestic and international senior leadership experience in pharmaceuticals and biotechnology, including capital markets, corporate governance, new product launches, including Fosamax ® Plus D, preclinical and clinical development, regulatory strategy, sales and marketing, business development, CMC and IP strategy. Dr. Lumsden received his Bachelor of Veterinary Medicine & Surgery from University of Edinburgh, U.K. and his Postgraduate Diploma in Marketing from the Chartered Institute of Marketing in the U.K. “Given the demonstrated benefits for patients of medicines targeting the MARCKS protein, this is a great opportunity to build on the work of the Biomarck team to date,” said Dr. Lumsden. “In addition to the respiratory lead programs, this mechanism lends itself to other indications where patients currently have limited or no therapeutic options. I am excited to join the team and look forward to executing on Biomarck’s mission of delivering proven therapies for patients with inflammatory, oncological and other difficult to treat diseases.” About Biomarck Pharmaceuticals, Ltd. Biomarck is a biopharmaceutical company focused on the development of drugs to treat ARDS, COPD, cancer and other hard to treat diseases. With over 100 patented peptides in our global portfolio, we utilize anti-MARCKS proteins to selectively inhibit cancer progression and the inflammatory cytokine release involved in respiratory diseases and other severe illnesses. Learn more about our platform technology and how we are developing safe and targeted treatments for patients in need at . View source version on businesswire.com:

30 Jan 2020

·www.biospace.com

Motif Bio Corporate Update - Agreement with Hercules Capital, Inc

The Company and its wholly owned subsidiary, Motif BioSciences Inc., have entered into a loan Amendment and Release agreement with Hercules Capital Inc., the senior secured lender to Motif Inc, regarding certain actions which fully satisfy the conditions attached to the Company’s previously announced agreement in principle with Hercules 28 January 2020 Motif Bio plc (“Motif Bio” or the “Company”) Corporate Update Agreement with Hercules Capital, Inc Reclassification as a Rule 15 Cash Shell Motif Bio plc (AIM/Nasdaq: MTFB) today provided an update on recent corporate developments following the General Meeting held on 14 November 2019 (the “General Meeting”). Agreement with Hercules Capital, Inc The Company and its wholly owned subsidiary, Motif BioSciences Inc. (“Motif Inc”), have entered into a loan Amendment and Release agreement with Hercules Capital Inc. (“Hercules”), the senior secured lender to Motif Inc, regarding certain actions which fully satisfy the conditions attached to the Company’s previously announced agreement in principle with Hercules (the “Hercules Agreement”). Pursuant to the terms of the Hercules Agreement: Hercules is relinquishing the loan guarantee provided by the Company and relieving Motif Bio plc of any future obligations to Hercules related to the November 2017 Hercules Loan to Motif Inc (the “Loan Agreement”). Motif Inc. has granted Hercules a perfected security interest in all of its intellectual property. To facilitate the wind down of Motif Inc. and potential sale of iclaprim related assets, Hercules has agreed with Motif Inc. to certain forbearance provisions under the Loan Agreement through to June 2020. The terms of the Hercules Agreement are effective immediately, except for provisions of a release that relate to the pledge of Motif Bio’s interest in Motif Inc. which will become effective no later than 10 May 2020, being approximately 100 days after Hercules’s security interest in all of the intellectual property of Motif Inc. is perfected, provided that no voluntary or involuntary bankruptcy filing has occurred with respect to Motif Bio or Motif Inc. Consistent with the resolutions passed at the General Meeting, the Company is granting to Hercules warrants over 24,267,408 ordinary shares and warrants over 97,069,633 ordinary shares which aggregate to 121,337,041 ordinary shares of 0.01 pence (“Ordinary Shares”), representing a total of 25 per cent of the Company’s outstanding share capital (the “Hercules Warrants”). The Hercules Warrants will expire on 27 January 2025 and have an exercise price of 0.42 pence, which is consistent with the placing price of the Company’s Conditional Placing, which was announced on 2 October 2019. Motif Inc. has ceased all operations and has engaged Tamarack Associates to facilitate the sale of iclaprim and other assets of Motif Inc. In spite of a comprehensive outreach program, no transaction is currently pending for the sale of Motif Inc.’s assets and there is no assurance that there will be a transaction to monetise the assets. Consistent with the wind-down of operations of Motif Inc. and potential future sale of its assets, John Palmer of Tamarack Associates is being appointed as sole Executive Officer of Motif Inc. and Bernadette Barron of Barron Business Consultants is being appointed as the sole, independent non-executive officer of Motif Inc. Concurrent with these appointments, Graham Lumsden, Jonathan Gold, and David Huang have resigned as officers of Motif Inc. and Graham Lumsden has resigned as director of Motif Inc. Consistent with the information provided in the circular dated 25 October 2019, current directors have agreed to forfeit their outstanding vested and non-vested options. Graham Lumsden is voluntarily forfeiting 8,148,800 vested and non-vested options, Jonathan Gold is voluntarily forfeiting 1,330,941 vested and non-vested options, and Bruce Williams is voluntarily forfeiting 422,118 vested and non-vested options. Consistent with the information provided in the circular dated 25 October 2019, former directors Dr. Craig Albanese, Charlotta Ginman, Zaki Hosny, Dr. Mary Lake Polan, and Andrew Powell have forfeited their previously outstanding vested and non-vested options. In exchange for their forfeiture of their previously agreed Board fees, the Company is issuing to each of the above named former directors options over 1,200,000 ordinary shares at an exercise price of 0.24 pence (being the closing price on the date of execution of the Hercules agreement). Reclassification as a Rule 15 Cash Shell Following the execution of the Hercules Agreement, the Company will be reclassified as an AIM Rule 15 cash shell with immediate effect. As such, the Company will be required to make an acquisition which constitutes a reverse takeover under the AIM Rules within six months, failing which the Company’s ordinary shares would be suspended from trading on AIM pursuant to AIM Rule 40. The Company’s Directors are focused on sourcing an appropriate reverse takeover candidate for Motif Bio. There is no assurance that the effort will be successful to source and/or complete a reverse takeover transaction. The Company’s Directors will provide shareholders with further updates as appropriate. Current Financial Position Motif Bio’s cash balance was approximately £0.4 million as at 27 January 2020 and the Company currently has sufficient working capital to May 2020. As such, the Directors continue to impose disciplined cost controls and the Company is maintaining very limited operations. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. For further information please contact: Motif Bio plc ir@motifbio.com Graham Lumsden (Chief Executive Officer) SP Angel Corporate Finance LLP (NOMAD & BROKER) +44 (0)20 3470 0470 David Hignell/Caroline Rowe (Corporate Finance) Vadim Alexandre/Abigail Wayne (Sales & Broking) Walbrook PR Ltd. (UK FINANCIAL PR & IR) +44 (0)20 7933 8780 Paul McManus/Lianne Cawthorne motifbio@walbrookpr.com

Executive Change

100 Deals associated with Iclaprim

External Link

KEGG	Wiki	ATC	Drug Bank
D08337	Iclaprim	J01EA03	DB06358

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cellulitis	Phase 3	United States	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Argentina	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Belgium	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Bulgaria	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Chile	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Colombia	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Croatia	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Czechia	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Estonia	Motif Bio Plc	01 Nov 2015
Cellulitis	Phase 3	Germany	Motif Bio Plc	01 Nov 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02600611 \| NCT02607618 (REVIVE-1 and REVIVE-2, Pubmed \| Int J Antimicrob Agents)	Phase 3	Skin and skin structure infections	-	Iclaprim 80 mg	obzjhsvysm(elxjlxmytf) = pvvysmtrcb kqqhaeiruc (bwunqvxgzx )	Positive	01 Aug 2018
				Vancomycin 15 mg/kg	obzjhsvysm(elxjlxmytf) = txtcymiabe kqqhaeiruc (bwunqvxgzx )
NCT02607618 (REVIVE-2, CTgov)	Phase 3	Skin structures and soft tissue infections \| Skin Diseases, Bacterial \| Erysipelas ... View more	613	Iclaprim (Iclaprim)	quhkymjoex = aeorrxnsal uugebzmnvg (afllupzhif, wzkzzrcmnt - lyxdptptup) View more	-	11 Jul 2018
				Vancomycin (Vancomycin)	quhkymjoex = vfajuxnszn uugebzmnvg (afllupzhif, gjxwjnqdpu - jvcemgefso) View more
NCT02600611 (REVIVE-1, CTgov)	Phase 3	Skin structures and soft tissue infections \| Skin Diseases, Bacterial \| Erysipelas ... View more	600	iclaprim (Iclaprim)	bvhphtqtbm = cqsckipymf icyqurzdfl (kmdklyggur, btuxypbrpc - vvtcftbbti) View more	-	19 Jun 2018
				Vancomycin (Vancomycin)	bvhphtqtbm = zuqwcgbarw icyqurzdfl (kmdklyggur, erhsnqsbga - zjczzyjvvh) View more
NCT02607618 (REVIVE-2, Pubmed \| Antimicrob Agents Chemother) Manual	Phase 3	Skin and skin structure infections	613	Intravenous Iclaprim	mxpqrhrkny(oaltgmoluk) = yguynpdkhq ewixwfeauw (jewvnqtrys )	Non-superior	26 Apr 2018
				Vancomycin	mxpqrhrkny(oaltgmoluk) = akvliodydr ewixwfeauw (jewvnqtrys )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis