Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (March 2019)
72 slides from Theriva Biologics's investor presentation, Mar 4, 2019
Slide 1: Company Overview March 2019
March 2019 Company Overview Updated 3.4.2019
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation includes forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 , as amended, on Synthetic Biologics’ current expectations and projections about future events . In some cases forward - looking statements
Slide 3: Financial Snapshot
Financial Snapshot Synthetic Biologics, Inc. Capitalization Table December 31, 2018 Common Shares Outstanding 15,484,411 Series A Preferred Shares 2 120,000 Series A Common Equivalents 634,921 Series B Preferred Shares 9,161 Series B Common Equivalents 7,966,087 Stock Options Issued (2007 & 2010 Pla
Slide 4: About Synthetic Biologics
About Synthetic Biologics • Diversified microbiome - focused company pioneering proprietary early & late - stage product candidates designed to protect and preserve the gut microbiome: • SYN - 010 , for the treatment of an underlying cause of irritable bowel syndrome with constipation (IBS - C); • S
Slide 5: Our Leadership Team
Our Leadership Team Steven Shallcross, CEO & CFO Vanda Pharmaceuticals, Inc., Empire Petroleum Partners, LLC, Innocoll AG (formerly privately held Innocoll Holdings, Inc.) Raymond Stapleton, PhD, SVP, Manufacturing Merck & Co., Inc. Michael Kaleko, MD, PhD, SVP R&D Genetic Therapy, Inc. (Novartis),
Slide 6: SYN Portfolio
AAD antibiotic associated diarrhea; aGVHD acute graft - vs - host disease; AMR antimicrobial resistance; CDI Clostridium difficile infection; CIC chronic idiopathic constipation; CPI checkpoint inhibitor autoimmune enteropathy; CRE carbapenem resistant enterococci; DR delayed release; Est. estimated
Slide 7: Milestones & Potential Value Drivers
Q3 Q4 Q1 - Q2 Q3 Q4 Milestones & Potential Value Drivers 2018 2019 SYN - 010 Agreement with Cedars - Sinai to co - fund Phase 2b investigator - sponsored clinical study SYN - 010 Initiated Patient enrollment in Phase 2b investigator - sponsored clinical study (Cedars - Sinai) SYN - 004 Announced res
Slide 8: SYN-010 Novel Treatment for IBS-C
SYN - 010 Novel Treatment for IBS - C
Slide 9: Constipation is an Enormous Problem
Up to 14% of US adults ( 6% Chinese adults) have chronic constipation $3,508 average additional healthcare cost in US per patient per year Up to 5% of US adults ( 1% Chinese adults) suffers from IBS - C $3,856 average additional healthcare cost per patient per year Only 8% of IBS patients and 14% of
Slide 10: US IBS and Constipation Market
US IBS and Constipation Market • Digital and DTC campaigns are enhancing awareness of both IBS and gut health • New entrants are growing the market, not cannibalizing it • Opportunity for treatments with a novel mode - of - action and improved side - effect profile $2.5B Market Growth Drivers IMS He
Slide 11: SYN-010 is a Unique Approach to Treating IBS-C
Constipation Pain Bloating Directly targeting a microbial cause of IBS - C symptoms SYN - 010 is a Unique Approach to Treating IBS - C Bisacodyl Erythromycin Prucalopride Senna Linaclotide Lubiprostone Plecanatide Tenapanor PEG Senna SYN - 010 11 Intestinal methane production alters gut motili
Slide 12: SYN-010 Modified Release Lovastatin Lactone
Preserve lovastatin in the lactone form; target methanogens in the lower GI tract SYN - 010 Modified Release Lovastatin Lactone SYN - 010 Hubert S (2017) J Pharm Sci 107: 662 - 71. Marsh E (2015) Am J Gastroenterol 110 (Suppl 1) :S753. Stomach pH 1.4 - 2.0 Duodenum pH 5.9 - 6.6 Jejunum pH 6.6 - 7.4
Slide 13: SYN-010 Clinical Proof-of-Concept
• Patients meeting Rome III criteria for IBS - C enrolled at 12 sites in the USA • Breath methane >10 ppm at screening • Single, daily oral doses of SYN - 010 • IBS - C symptoms reported daily using ePRO devices • Symptom responses observed over 12 - weeks • Increased BM frequency, decreased breath
Slide 14: SYN-010 Phase 2b Clinical Trial
SYN - 010 effects on IBS - C symptoms, breath gases and microbiome parameters SYN - 010 Phase 2b Clinical Trial Treatment Period EOS | | | | | | | | | - 17 - 14 1 14 28 42 56 70 84 Screen | - Diary Baseline - | DAY Pretreatment LBT LBT Clinic Visits Lactulose Breath Test Breath CH 4 H 2 H 2 S CO 2 C
Slide 15: SYN-010 Potential Differentiating Benefits
• Targets a microbial cause of IBS - C symptoms • Anticipate more predictable efficacy, potential patient selection with biomarker • Chronic daily therapy for the lifetime of the disease • May normalize bowel habits, avoid cycling through symptom relief and recurrence • Potential safety and efficacy
Slide 16: SYN-010 Strategy
SYN - 010 Strategy • EOP2 meeting held with FDA after Phase 2a clinical trial (July 2016) • Agreed on Phase 3 program to address dose - response, evaluate potential food effects, and establish long - term safety (~$80M) • Potential to simplify Phase 3 program based on Phase 2b data • Ideally, propos
Slide 17: SYN-004 (ribaxamase) Prevention of aGVHD in HCT
SYN - 004 (ribaxamase) Prevention of aGVHD in Hematopoietic Cell Transplant
Slide 18: The Gut Microbiome and Disease Prevention
• The gut microbiome is a complex community of ~39 trillion microbes in our gastrointestinal tract¹ • Predominantly reside in the colon • The microbiome is integral to our health² • Cancer, CNS, GI, immune system, infection, metabolism • Antibiotic damage to the microbiome can cause disease • Emerge
Slide 19: Protect the Gut Microbiome: Antibiotic Damage
β - lactam antibiotic excreted into the GI tract damages the microbiome SYN - 004 (ribaxamase) to Protect the Gut Microbiome Antibiotic Excreted in Bile IV β - LACTAM ANTIBIOTIC Stomach Duodenum Jejunum Ileum Cecum Colon β - Lactam Antibiotic 19 Healthy Microbiome DAMAGED Microbiome
Slide 20: SYN-004 (ribaxamase) to Protect the Gut Microbiome
Degrading β - lactam antibiotic excreted into the GI tract SYN - 004 (ribaxamase) to Protect the Gut Microbiome SYN - 004 (ribaxamase) Antibiotic Excreted in Bile IV β - LACTAM ANTIBIOTIC Stomach Duodenum Jejunum Ileum Cecum Colon 20 Enteric protection intended to prevent gastric release and limit a
Slide 21: SYN-004: Multiple Disease Prevention Opportunities
SYN - 004: Multiple Disease Prevention Opportunities 21 AMR infographic: https://www.antimicrobialsworkinggroup.org/antimicrobial - resistance/ aGVHD image: Naymagon S (2017) Nature Rev Gastroenterol Hepatol 14 : 711 – 26 Cephalosporin or Penicillin Antibiotic SYN - 004 CDI AMR aGVHD Clostridium dif
Slide 22: SYN-004 (ribaxamase) Clinical Proof-of-Concept
• Patients admitted for treatment of LRTI at 54 sites (Europe, North America) • Achieved primary endpoint • Reduced CDI incidence by 71.4% vs Placebo (1.0% vs 3.4% P=0.045) • Preserved the microbiome • Reduced ceftriaxone - mediated loss of microbial diversity vs Placebo • Suppressed AMR • Reduced V
Slide 23: Allogeneic Hematopoietic Cell Transplantation (HCT)
• Approximately 8,539 allogeneic HCT procedures conducted in the USA (~4,500 in China) in 2016¹ , ² • IV β - lactam antibiotics are used to treat febrile neutropenia in 80 - 90% of allogeneic HCT recipients³ • Microbiome damage by IV β - lactam antibiotics is strongly associated with aGVHD, VRE bact
Slide 24: SYN-004 to Prevent aGVHD: Lives and Costs
• In - patient costs for allogeneic HCT in the USA range from $180,000 to >$300,000 depending on the disease severity¹ - ³ • All - cause costs for allogeneic HCT in the USA in 2014 were >$600,000 per patient (up to 12 months post transplant)³ • Allogeneic HCT recipients who develop aGVHD have a 3 -
Slide 25: SYN-004 Clinical Development in HCT
• Phase 1/2 clinical trial to evaluate SYN - 004 safety¹ • Allogeneic HCT recipients (n≈40) receiving IV β - lactam antibiotics to treat neutropenic fever • Critical to demonstrate that SYN - 004 does not alter antibiotic PK or efficacy • Key investigators identified, clinical protocols and pre - IN
Slide 26: SYN-004 (ribaxamase) Long-Term Value Strategy
SYN - 004 (ribaxamase) Long - Term Value Strategy CDI, AMR Infection Control Estimated Clinical Trial Size (n) Estimated Value 10’s - 100’s of Millions Patients⁴ aGVHD HCT 3,000 - 4,000 800 - 1,000 300 - 500 CDI, AMR Solid Organ Transplant 10,000 - 20,000 Patients¹ , ² Estimated patient numbers are
Slide 27: SYN-020 Treatment of Specific Colitis Conditions
SYN - 020 Treatment of Specific Colitis Conditions
Slide 28: Intestinal Alkaline Phosphatase
• Maintains gastrointestinal homeostasis¹ , ² • Detoxifies inflammatory mediators³ • Endotoxin, bacterial DNA, flagellin, nucleotides • Tightens the gut barrier⁴ , ⁵ • Prevents “leaky gut” • Diminishes endotoxemia • Promotes the growth of commensal intestinal flora ⁶ Intestinal Alkaline Phosphatase
Slide 29: IAP has Demonstrated Efficacy in Animals and Humans
Model Outcome Humans Ulcerative Colitis Clinical improvement in refractory UC at 21 days following one week of cIAP infusion via nasoduodenal tube¹ Type 2 Diabetes High IAP levels are associated with protection from diabetes even in obese individuals² Mice Leaky Gut Diminished endotoxemia in high -
Slide 30: Overcoming Key IAP Development Challenges
• Manufacturing has limited the clinical progress of oral IAP • cIAP is extracted from calf intestine and requires extensive purification, costing up to $10,000/g¹ • IAP yields are very low ( 10 - 500 mg/L ) in many manufacturing platforms² - ⁵ • Synthetic Biologics has developed a stable cell line
Slide 31: SYN-020 (IAP) Protects the Intestinal Mucosa
31 SYN - 020 (IAP) Protects the Intestinal Mucosa Reduced submucosal inflammation in DSS - colitis model Control Vehicle SYN bIAP II, 500 U/day ¹ Bol - Schoenmakers M (2010) Eur J Pharmacol. 633: 71 - 7 ²Efficacy equivalent to literature reports was seen at a SYN bIAP II dose of 100 U/day Male C57BL
Slide 32: SYN-020 Planning IND Filing
• Treatment/prevention of radiation enteropathy secondary to cancer therapy • Pelvic and abdominal irradiation is used >300,000 times annually in US¹ • 60 - 80% of radiation - treated cancer patients suffer acute bowel toxicity • Significant unmet need for both inflammatory acute and fibrosing chron
Slide 33: Appendix
Synthetic BIOLOGICS Appendix March 2019
Slide 34: SYN-010 Novel Treatment for IBS-C
SYN - 010 Novel Treatment for IBS - C
Slide 35: CH4 Causality: IBS-C Symptoms Transmitted by FMT
CH 4 Causality: IBS - C Symptoms Transmitted by FMT Chang B (2016) Am J Gastroenterol 112 : 186 - 7. CDI = Clostridium difficile infection unresolved by vancomycin and metronidazole. Eradication = 14 days of rifaximin 550 mg t.i.d. plus neomycin 500 mg b.i.d. FMT Eradication CDI No other GI symptoms
Slide 36: IBS-C Symptom Responses in Phase 2a Clinical Trials
IBS - C Symptom Responses in Phase 2a Clinical Trials CSBM Response: An increase from day 1 baseline of ≥1 Complete Spontaneous Bowel Movement per week in ≥50% of the weeks. Abdominal Pain (or Bloating) Response: A ≥30% decrease from baseline in weekly average worst abdominal pain (or bloating) scor
Slide 37: Phase 2a Safety and Adverse Events
Parameter Cohort 1 Cohort 2 Cohort 3 Study RCT EXT RCT EXT RCT EXT SYN - 010 Dose Placebo 42 mg 21 mg 42 mg 42 mg 42 mg Enrolled , n 22 17 22 20 19 17 Withdrew, n 2 2 2 2 2 1 Reported SAE, n 0 0 0 0 0 0 Reported TEAE, n 1 2 2 2 2 2 Treatment Emergent Adverse Event (TEAE; Relationship to Treatment)¹
Slide 38: Decreased Rescue Laxative Use
Decreased rescue laxative use consistent with increased SBMs SYN - 010 Groups Used Less Rescue Mediation ¹Rescue medication use was reported by subjects each day in an electronic diary. ²Nominal P values for Fisher’s exact test vs Pl acebo. 38
Slide 39: Lower Methane Correlated with Increased BMs
SBMs and CSBMs increased when methane is reduced Lower Methane Correlated with Increased BMs ¹Correlation line represents least - squares linear regression modeling. ²Weekly no. CSBMs at Week 12 (mean ± SD) for all subjects completing the EXT (n=48): 1.54 ± 1.52 39
Slide 40: SYN-010: No Meaningful or Persistent Systemic Effects
SYN - 010 No Meaningful or Persistent Systemic Effects Consistent with reduced systemic exposure to lovastatin β - hydroxyacid • Plasma trough levels of lovastatin species measured during the RCT were low and variable¹ • ≥50% of patients had undetectable plasma trough levels of each analyte on days
Slide 41: SYN-010 Prior Regulatory Interactions
• FDA recommended a first Phase 2/3 adaptive clinical trial (~$25M) • Single daily doses of Placebo, SYN - 010 21 mg or SYN - 010 42 mg for 12 weeks • Both low - and high - breath methane patients to be included • FDA required additional studies (~$45M) • Second 12 - week phase 3 study with 4 - week
Slide 42: SYN-010 Comparison to Other IBS-C Products
SYN - 010 Comparison to Other IBS - C Products Parameter SYN - 010 Linaclotide Lubiprostone Plecanatide Tenapanor Company Synthetic Biologics Allergan / Ironwood Takeda / Sucampo Synergy Ardelyx Brand -- Linzess® Amitiza® Trulance™ -- Current Status Phase 2b Market Market Market Phase 3 Clinical Tri
Slide 43: SYN-010 Phase 2b/3 Adaptive Clinical Trial (FDA)
SYN - 010 effects on IBS - C symptoms in high - and low - breath methane producers SYN - 010 Phase 2b/3 Adaptive Clinical Trial (FDA) Treatment Period EOS | | | | | | | | - 17 - 14 1 8 22 29 57 85 Screen | - Diary Baseline - | DAY Pretreatment SYN - 010 21 mg q.d. (n=280) SYN - 010 42 mg q.d. (n=280
Slide 44: Why Include Low Breath Methane Patients?
IBS - C patients with low breath CH 4 but high gut CH 4 should also benefit from SYN - 010¹ Why Include Low Breath Methane Patients? ¹Kim G (2012) Dig Dis Sci 57: 3213 - 8 ; the population prevalence of IBS - C patients with low breath CH 4 but constipating gut CH 4 has not been established. Breath
Slide 45: SYN-010 Patent Position
Pending Patent Applications • Formulations • Methods of Use in Specific Patient Populations • Clinical Dosing Expires 2035 Patented and Pending Methods of Treatment Treat Constipation with SYN - 010 in Screened Patients Expires 2034 Patented Methods of Treatment Broadest Indication Expires 2023 Exte
Slide 46: SYN-004 (ribaxamase) Preventing aGVHD and VRE
SYN - 004 (ribaxamase) Preventing aGVHD and VRE
Slide 47: Allogeneic HCT, Antibiotics and Adverse Outcomes
Allogeneic HCT, Antibiotics and Adverse Outcomes Shono Y (2016) Sci Transl Med 8: 339ra71. Taur Y (2012) Clin Infect Dis 55: 905 - 14. Tavadze M (2014) Bone Marrow Transp l ant 49: 1310 - 16. Dubberke ER (2010) Clin Transplant 24: 192 - 8. Dubberke ER (2017) Transplant Dir 3: e145. D’Souza A (2017)
Slide 48: SYN-004 (ribaxamase) Addressing a Global Problem
SYN - 004 (ribaxamase) Addressing a Global Problem
Slide 49: Antibiotics can Damage the Microbiome
Antibiotic use worldwide Antibiotics can Damage the Microbiome β - Lactam Antibiotics Some of the worst intestinal microbiome damaging agents ~64% of the World’s antibiotics ~57% of US antibiotics 100’s of millions of patients 49 IV, PO Cephalosporins IV, PO Penicillins IV Carbapenems 49.6B Doses AL
Slide 50: SYN-004 (ribaxamase)
N S NH 2 N O CH 3 O NH NH S O S N N NH O O CH 3 NaO O OH N S NH 2 N O CH 3 O NH N S O S O N N NH O O CH 3 NaO SYN - 004 (ribaxamase) Proprietary oral formulation of an antibiotic - degrading enzyme • Enteric - protected, oral formulation of a proprietary class A, β - lactamase (P3A) • First generati
Slide 51: Clostridium difficile
Clostridium difficile Gram positive, spore - forming bacterium • Exists as toxigenic and non - toxigenic species in the colon • Up to 15% of healthy adults have asymptomatic C. difficile colonization¹ , ² • Readily transmitted by contact with spores • Symptomatic C. difficile infection ( CDI ) is du
Slide 52: Clostridium difficile Infection is Costly
606,058 CDI patients in the USA in 2014 ~7 extra days spent in the hospital by CDI patients² $5.4B added cost to healthcare and community in 2014 44,500 CDI - attributable deaths (7%) Epidemiological and economic burden of CDI in the USA from a modeling approach¹ Clostridium difficile Infection is C
Slide 53: Antimicrobial Resistance (AMR)
• AMR is a serious global threat - world leaders are taking action • Governments recognize the need to expedite drug review timelines • Leaders in industry and academia are developing action plans • Worldwide concern over potential Antibiotic Armageddon ¹ • Failure to address AMR may result in 10 mi
Slide 54: SYN-004 (ribaxamase) Development
Dog Toxicology & PK Phase 1a SYN - 004 Single Dose Phase 2a SYN - 004 + ceftriaxone IV SYN - 004 (ribaxamase) Development Pig Microbiome Protection Phase 2a SYN - 004 + ceftriaxone IV + PPI Phase 1b SYN - 004 Multiple Dose • Safe and well tolerated in dogs ( NOAEL 57 mg/kg/day )¹ • Degraded ceftriax
Slide 55: SYN-004 Phase 2b Clinical Trial
Prevention of CDI in patients receiving IV ceftriaxone to treat a LRTI SYN - 004 (ribaxamase) Phase 2b Clinical Trial ¹ LRTI clinical diagnosis of moderate to severe lower respiratory tract infection. ²Ceftriaxone in - patient IV dosing regimen and length of dosing were determined by local standard
Slide 56: SYN-004 Phase 2b Trial Results: CDI reduction
Ribaxamase caused a 71.4% reduction in CDI (achieved primary endpoint) SYN - 004 (ribaxamase) Phase 2b Trial Results ¹Patients are determined to have CDI (also called C. difficile associated diarrhea or CDAD) if they have diarrhea and the stool sample is positive for C. difficile toxin A and/or B (o
Slide 57: SYN-004 Phase 2b Trial Results: VRE colonization
Ribaxamase caused a 43.9% reduction in new colonization by VRE SYN - 004 (ribaxamase) Phase 2b Trial Results ¹ VRE = Vancomyin - resistant enterococci; new colonization means patient samples were negative at screening (T 0 ) but positive at either T 1 (72h) or T 2 (Week 4) so T 2 (Week 4) data are c
Slide 58: SYN-004 Phase 2b Trial Results: Diarrhea
Trend to decreased diarrhea overall in ribaxamase treatment groups SYN - 004 (ribaxamase) Phase 2b Trial Results ¹ CDI (also called C. difficile associated diarrhea or CDAD) means the diarrhea stool sample is positive for C. difficile toxin A and/or B (or their respective genes, tcdA and/or tcdB );
Slide 59: SYN-004 Protected the Gut Microbiome
SYN - 004 (ribaxamase) Protected the Gut Microbiome ¹Shannon Index and Chao1 represent α - diversity, a measure of the microbial community composition within a sample ²Size of each ball is relative to the standard error of the sample group 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 8 8.1 8.2 1400 1600 1800 200
Slide 60: SYN-004 Phase 2b Demographics and Safety
Parameter Placebo Ribaxamase Dose Ceftriaxone IV infusion, days 8.4 ± 2.9 8.5 ± 3.1 Ceftriaxone, total g received 17.7 ± 6.9 18.9 ± 9.1 Study drug exposure, days 11.0 ± 3.3 11.0 ± 3.5 Demographics Subjects, n (% Female) 206 (38.8%) 206 (35.4%) White/Caucasian, n (%) 205 (99.5%) 206 (100%) Age , year
Slide 61: Fatal AEs Associated with Key Cardiac Risk Factors
• Patients with one or more of these 3 factors accounted for: • 79% of patients in the Placebo group ‒ 100% of Fatal AEs in the Placebo group (5/5) • 78% of patients in the SYN - 004 group ‒ 82% of Fatal AEs in SYN - 004 group (9/11) ‒ 5 of 6 Cardiac Fatal AEs in the SYN - 004 group • Percentage of
Slide 62: SYN-004 Phase 2b Safety Summary
• The increased number of cardiac fatal AEs in the SYN - 004 treatment group was attributable to a random disparate distribution of cardiac risk factors that predisposed patients in the SYN - 004 group to worse clinical outcomes • “No support for a reasonable possibility of a causal relationship bet
Slide 63: SYN-004 Phase 3 Clinical Trial (FDA)
Prevention of CDI in patients receiving IV β - lactam antibiotics SYN - 004 (ribaxamase) Phase 3 Clinical Trial (FDA) β - lactam AbX = penicillins (piperacillin/tazobactam, ampicillin/sulbactam) and cephalosporins (ceftriaxone, cefepime, cefoperazone ); IV dosing regimen and hospital length of stay
Slide 64: SYN-004 (ribaxamase) Patent Position
Pending Patent Applications • Methods of Manufacture • Clinical Dosing, Formulation • Methods of Treatment Expires 2035/6 Patented other β - Lactamase Composition of Matter & Uses Expires 2035 Patented ribaxamase Composition of Matter Expires 2031 Extensive patent portfolio, multiple protection stra
Slide 65: SYN-007 (ribaxamase) DR: Protecting the microbiome from oral β-lactams
SYN - 007 (ribaxamase) DR Protecting the microbiome from ORAL β - lactam antibiotics
Slide 66: SYN-007 (ribaxamase) DR for Oral β-Lactams
Designed to prevent oral β - lactam antibiotics from reaching the colon SYN - 007 (ribaxamase) DR for Oral β - Lactams SYN - 007 (ribaxamase) Treat Systemic Infection Stomach Duodenum Jejunum Ileum Cecum Colon Ribaxamase enzyme released into the lower small intestine degrades β - lactam antibiotic β
Slide 67: Prevention of Antibiotic Associated Diarrhea in Children
Prevention of antibiotic associated diarrhea ( AAD ) in children SYN - 007 (ribaxamase) DR Potential Indication Kuehn (2015) J Pediatr Pharmacol Ther 20: 90 – 104. Tähtinen PA (2011) N Engl J Med. 364: 116 - 26. Ferreira JB (2006) Braz J Otorhinolaryngol. 72: 104 - 11 67 Amoxicillin 2 - 18% Amoxicil
Slide 68: SYN-007 (ribaxamase) DR Status
SYN - 007 (ribaxamase) DR Status • Preclinical proof - of - concept achieved in dog models • Patent applications filed • Potential to expand preclinical evaluation to oral cephalosporins (cefuroxime, cefaclor ) • Same enzyme as phase 3 product SYN - 004; anticipate limited requirement for preclinica
Slide 69: SYN-006 (carbapenemase) Preventing CRE
SYN - 006 (carbapenemase) Preventing Carbapenem Resistance Enterococci (CRE)
Slide 70: SYN-006 (carbapenemase)
• Carbapenems are potent β - lactam antibiotics • Carbapenems are typically second - line therapy for febrile neutropenia ( FN ) in the USA but are first - line therapy for FN in China • Carbapenems and clindamycin were associated with more CDI than other antibiotics in randomized clinical trials an
Slide 71: SYN-006 (carbapenemase) Strategy
SYN - 006 (carbapenemase) Strategy • Preclinical proof - of - concept achieved in dog and pig models • Protected the gut microbiome without altering systemic ertapenem and meropenem PK¹ , ² • Patent applications filed • Potential to rapidly advance to Phase 1 clinical trials • Confirm absence of eff
Slide 72: SYN-006 China Development Rationale
• Potential clinical indication recommended by China KOL • Hematologist and Vice Chair of a National Committee evaluating infectious complications in cancer • Carbapenems are first - line treatment for febrile neutropenia (FN) in hematologic cancer patients in China (PIP/TAZO 2 ƒ ) • Clinical site p
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