19 Feb Timely Diagnosis and Precise Action – The Need of the Hour in the Sepsis Shock Industry
Sepsis is when the body reacts extremely to an infection and can quickly escalate into a life-threatening situation causing multiple organ failures. It affects more than 1.5 million people in the U.S and over 250,000 individuals succumb to it each year according to the Centers for Disease Control and Prevention (CDC). It not only costs $27 billion in healthcare costs but also causes 1 in 2 hospital deaths in the U.S.
Diagnosis plays a key role in the accurate detection and treatment of Sepsis, and will see a CAGR of 9.1% to reach an estimated USD 613.9 million by 2023 from USD 396.6 million in 2018, according to a report titled “Sepsis Diagnostics Market by Technology (Microbiology, Molecular Diagnostic, Immunoassay, Biomarkers), Product (Blood Culture Media, Instruments), Method (Automated), Test Type (Lab, POC), Pathogen (Bacterial, Fungal), End-User – Global Forecast to 2023″ by marketsandmarkets.
The growth in the market will primarily be on account of increasing surgical procedures, the growth in antibiotic-resistant bacterial strains, higher incidences of hospital acquired infections (HAI), rising geriatric population and most importantly improved diagnostic tools.
Meanwhile, sepsis and sepsis shock market is expected to grow at a CAGR of 7.9% and will be worth $5.9 billion by 2026, up from $2.8 billion in 2016 according to a report by GlobalData . The market will see major challenges in terms of the complexity in treating multiple organs affected by Sepsis simultaneously, the probative costs of treatment and insufficient insurance coverage.
Biotechnology companies are developing novel therapies that involve identification of novel biomarkers that will aid in drug development with focus on early detection, faster processing and targeting co-morbidities.
We take a look at some companies that are developing first-in-class treatments for tackling Sepsis and related complications.
T2 Biosystems (NASDAQ: TTOO)
Market Cap: $162.50M; Current Share Price: 3.69 USD
The company’s T2 Magnetic Resonance (T2MR®) detection technology is the foundation of all of its diagnostic innovations. The method uses miniaturized magnetic resonance technology for direct detection and measurement of biomarkers, pathogens and other abnormalities in whole blood, plasma, serum, saliva, sputum, and urine.
This novel method eliminates the need for purification or extraction of target molecules and can precisely identify molecular targets from the patient sample leading to a shortened diagnosis times and labor savings. It is the only FDA-cleared technology that can find low levels of pathogens in whole blood with as little as 1 CFU/mL, by using T2MR-powered T2Dx® Instrument.
It’s T2Bacteria® Panel can identify the bacteria responsible for sepsis from whole blood without waiting for a blood culture, it is the only such technology approved by the FDA. The time taken by the panel for species identification is merely 3 to 5 hours as against 1 to 5 days taken by the traditional methods. This helps healthcare providers to treat the infection in its early stages thereby improving the chances of survival and recovery. The biggest advantage of using this panel is that it is not affected by detection interference even when the patient is on antibiotics.
The company’s T2Candida Panel, is a direct-from-blood fungal pathogen detection assay that can help patients suffering from febrile neutropenia, septic shock, having LVAD or at an increased risk of developing candidemia, a condition whose mortality rate of 40% can be bought down to 11% by targeted treatment within 12 hours from the onset of infection. This method overcomes the limitation of the traditional candida diagnostic methods such as eliminating the need for a positive blood culture which are time consuming and inaccurate. It also helps reduce hospitalization costs by approximately $30,000 per patient by reducing the need for longer stay.
T2 has a strong pipeline of candidates that include T2Carba Resistance+ Panel a first-in-class detection panel that can identify gram-negative resistance markers such as Enterobacter and Klebsiella spp, developed in collaboration with Allergan and CARB-X. This has the potential to prevent the development of antibiotic resistance and arrest the spread of multidrug-resistant organisms.
In addition, it also has a T2Lyme Panel under development in partnership with Canon U.S. Life Sciences that can accurately detect the bacteria that cause Lyme disease and T2Candida auris Panel RUO that can detect emerging superbug in patient skin, blood and hospital environmental samples.
T2 biosystems has shown some impressive results in cost savings for both hospitals as well as patients as part of its stewardship program with institutions such as UPMC, Henry Ford Health System, Lee Health, Huntsville Hospital, Robert Wood Johnson Medical School, Riverside Community Hospital, etc.
Q-Linea AB (publ) (NASDAQ OMXS: QLINEA.ST)
Market Cap: $1.278B; Current Share Price: 55.80 SEK
Q-Linea’s ASTar™ instrument for Antibiotic Susceptibility Testing (AST) can generate a susceptibility profile within three to six hours directly from a positive blood culture that helps target disease-causing pathogens in a timely and accurate manner. It primarily develops diagnostic tools for infection detection.
The company which started with developing prototypes for identification of biological warfare agents such as anthrax and smallpox for the Swedish and French Army, changed gears to focus on the development of IVD systems for infectious diseases before launching the ASTar systems from 2017 onwards for the speedy assessment and analyses of identified pathogens using advanced mass spectrometry and molecular methods.
The ASTar system can generate MIC results in 3 to 6 hours directly from positive blood cultures using a fully-automated analysis system that can work on upto 50 samples a day, generating a comprehensive AST panel.
The system is based on highly specific padlock probe and circle-to-circle isothermal nucleic acid amplification technology (C2CA). It is extremely flexible and can be extended to all types of clinical samples such as blood culture, urine, respiratory, sterile aspirates and isolates.
In the pipeline is the ASTrID system through which samples can be analyzed and the cause of sepsis determined within 4 hours, leading to preparation of an antibiotic susceptibility profile within 6 hours. The Id panel will cover 95 percent of relevant pathogens including 33 unique pathogens and 10 pathogen groups, as well as 11 resistance markers.
The company recently issued an IPO in December 2018, raising approximately SEK 550 million, it is currently conducting clinical trials for ASTar in the EU and the US and has entered into a partnership agreement to fund these trials. The company also secured a funding of SEK 151.5 million from its existing shareholders and a group of Swedish investors led by AB Öresund and the Fourth AP fund in 2018.
Cytosorbents (NASDAQ: CTSO)
Market Cap: $262.08M; Current Share Price: 8.28USD
A leader in critical care immunotherapy, its CytoSorb is the first-in-class treatment for Cytokine absorption in case of Cytokine Storm. Its technology is based on biocompatible polymer beads that eliminate toxic substances from blood by pore capture and surface absorption and can control life-threatening inflammation in critical scenarios in the ICU that could lead to organ failure and death. The product is currently marketed in over 53 countries across the world including the European Union.
It also manufactures a similar product for the animal health market namely VetResQ®,that is available in the U.S. In the pipeline is a filter for packed red cell transfusion HemoDefend that is in clinical trial stage and will be presented for FDA approval in 2019. It’s CytoSorb-XL, ContrastSorb, DrugSorb, BetaSorb and Potassium Binder are in various stages of clinical development as well.
The company’s proprietary blood purification technology is protected by over 17 patents. The company has a strategic marketing and distribution agreement with Fresenius Medical Care, the world leader in dialysis treatment, for France, Norway, Finland, Sweden, Denmark and Poland. It has an agreement with Terumo Cardiovascular, a leader in cardiac and vascular surgery to distribute CytoSorb® for cardiac surgery applications in France, Norway, Sweden, Finland, Denmark, and Iceland. For India, Sri Lanka, Malaysia and select emerging markets it has tied up with Biocon Ltd (NSE: BIOCON), India’s largest biopharmaceutical company. While Dr. Reddy’s Laboratories Ltd (NYSE: RDY), is the distributor for South Africa.
Over 46,000 human treatments to date have safely used CytoSorb®. It has an ISO 13485 certified manufacturing facility in New Jersey. The company is the recipient of Frost & Sullivan’s Global Product Leadership Award for its contribution to critical-care immunotherapy segment in blood purification.
The company enjoys a strong government patronage with over $25M received in forms of grants, contracts, other non-dilutive funding.
As per its latest financial results, the company reported $19.1 million in trailing 12-month product sales registering an increase of 63% from a year ago. It also reported an increase in revenue to $5.7 million, up from $3.8 million in Q3 2017. The company reported cash and cash equivalents of $25.3 million as on 30 September, 2018.
ENLIVEX Therapeutics, acquired by Bioblast Pharma Ltd. (NASDAQ: ORPN)
The company develops immunomodulating cell therapies that can regulate hyperimmune responses that lead to life-threatening organ failures. The company’s proprietary immunotherapy Allocetra™ is designed to use the body’s natural regulation mechanisms consisting of macrophages and dendritic cells to rebalance hyperactivity in immune cells. It seeks to leverage its innovative technology to capture a major share of the $12.50 billion severe sepsis market.
The company is being acquired by Bioblast Pharma Ltd. and the formalities of the merger are expected to be completed in Q1 of 2019. Upon merger, the combined company will be renamed as Enlivex Therapeutics Ltd.
ALLOCETRA™ is currently in Phase Ib-II clinical trials and the dosing is expected to start in Q1 of 2019. It plans to leverage on accelerated regulatory support in form of FDA and EU’s Orphan drug status for GVHD to make rapid advancements in addressing the unmet needs in the field of immunotherapy. It has a partnership agreement with Pfizer Inc. (NYSE: PFE) for ALLOCETRA™, having received a $295 million down payment and a further $275 expected upon FDA approval.
Enlivex also has a strong intellectual property rights portfolio with patents on immune disease medicament, disease therapy and therapeutic apoptotic cell preparations. It has two more patents filed and is awaiting grant of patent for combination immune therapy and cytokine control therapy for cancer treatment and therapeutic pooled blood apoptotic cell preparations.
The company has an impressive pipeline of products in the offing under various stages of clinical trials ranging from a treatment for the prevention of complications from bone marrow transplantations such as Graft Vs. Host Disease to sepsis related organ failure and mortality.
Market Cap: $51.87M; Current Share Price: 0.225 USD
Spectral’s lead product candidate PMX, a therapeutic hemoperfusion device, is being developed for treatment of patients with septic shock and endotoxemia (measured by the company’s Endotoxin Activity Assay (EAA™). The product is currently undergoing Phase III clinical trial in the U.S. The company markets its products in Canada presently.
Spectral’s EAA™ Endotoxin Activity Assay is a rapid diagnostic tool for endotoxin activity in blood and is approved for clinical use by the FDA since 2003, various studies conducted on EAA has proven its efficacy. PMX (Toraymyxin hemoperfusion), a Polymyxin B extracorporeal direct hemoperfusion adsorption column is used for eliminating endotoxin from the bloodstream. The product is currently being marketed in Europe, Canada and Japan and is awaiting a PMA approval from the FDA in the U.S.
In addition, the company has developed a continuous renal replacement therapy (CRRT) machine that offers the dual advantage of both dialysis and CRRT approaches to renal replacement. The product has received a FDA 510k clearance in the U.S. It has licensing agreements with industry leaders for its single-chain Troponin I-C polypeptides, and other reagent products for use in large instrument calibration and control.
The company has entered into a distribution agreement for its proprietary CRRT machine with a private U.S. company according to a press release.
EAA/PMX enjoy up to 10 years of patent protection, in addition PMX will enjoy 6-10 years of market exclusivity when approved as a PMA. It’s “SAM” CRRT machine has patent protection for 10 years. The company expects to complete its add-on PMX trial and capture a majority share of the $1.5 billion US- sepsis market in 2021.
As on 1 January, 2019, the company reported a cash and cash equivalents of $5 million.
Arnold HM, et al. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 2010
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.