Larimar Therapeutics, Inc. · NASDAQ:LRMR
Larimar Therapeutics — Zafgen — American Diabetes Association 78th Scientific Sessions Investor & Analyst Update Call (June 2018)
15 slides from Larimar Therapeutics's conference presentation, Jun 25, 2018
Slide 1: American Diabetes Association 78th Scientific Sessions Investor & Analyst Update Call
American Diabetes Association 78th Scientific Sessions Investor & Analyst Update Call June 25, 2018
Slide 2: Forward-Looking Statement
Forward-Looking Statement These slides and the accompanying oral presentation contain forward-looking statements and information. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue
Slide 3: Highlights for ZGN-1061 from ADA
Highlights for ZGN-1061 from ADA • Phase 2 data for ZGN-1061, a novel MetAP2 inhibitor in development for difficult to control type 2 diabetes, presented at ADA • Positive data reinforce excitement for potential of ZGN-1061 • Met all primary endpoints delivering a statistically significant reduction
Slide 4: Phase 2 Proof-of-Concept Clinical Trial Design
Phase 2 Proof-of-Concept Clinical Trial Design 12 weeks ZGN-1061 0.05 mg q 3 d SQ 10 day 12 weeks ZGN-1061 0.3 mg q 3 d SQ 4 week placebo follow-up lead-in 12 weeks ZGN-1061 0.9 mg q 3 d SQ 12 weeks placebo q 3 d SQ Objective: Evaluate efficacy and safety of ZGN-1061 at a low-to-mid dose in patients
Slide 5: Baseline Demographics Well-Balanced Across Dosing Groups
Baseline Demographics Well-Balanced Across Dosing Groups 0.05 mg 0.3 mg 0.9 mg Placebo N=32 N=34 N=33 N=30 Age, y 55.8 ± 7.6 53.9 ± 9.3 54.9 ± 7.6 52.8 ± 8.2 % Male 56 38 61 57 % White/Asian/Other 78/3/19 68/6/26 82/0/18 83/0/17 Duration of T2D, y 8.0 ± 6.0 7.2 ± 5.8 8.4 ± 5.6 7.6 ± 5.2 A1C, % 8.64
Slide 6: ZGN-1061 Produced a Progressive and Statistically Significant Improvement in A1C for 0.9 mg
ZGN-1061 Produced a Progressive and Statistically Significant Improvement in A1C for 0.9 mg ZGN-1061 • Statistically significant reduction in A1C for 0.9 mg vs placebo at Weeks 8 and 12 • A1C continued to decline with no waning of effect through Week 12 for 0.9 mg dose • No meaningful change in A1C
Slide 7: ZGN-1061 Improved Measures of Glycemic Control
ZGN-1061 Improved Measures of Glycemic Control • Statistically significant reduction in fasting plasma glucose (FPG) for 0.9 mg dose vs placebo at Week 12 • In a subset of participants who underwent Mixed Meal Tolerance Test (MMTT) • ZGN-1061 reduced 2h Postprandial Glucose (PPG) FPG data are LS mea
Slide 8: ZGN-1061 Improved Additional Secondary Measures
ZGN-1061 Improved Additional Secondary Measures • Improvements in FGF21, adiponectin, and leptin for ZGN-1061 0.9 mg dose vs placebo • Additional trends in lipid improvements for ZGN-1061 vs placebo • Moderate weight loss observed for both ZGN-1061 (-1.5 ±0.4 kg, BL 105.8) and placebo (-0.9 ±0.4 kg,
Slide 9: ZGN-1061 Generally Safe and Well Tolerated
ZGN-1061 Generally Safe and Well Tolerated • Adverse events primarily mild or moderate with overall study completion rate of 95% • Most frequent AEs were injection site bruising, upper respiratory tract infection, and diarrhea • Two patients (both 0.9 mg ZGN-1061) reported SAEs (upper abdominal pain
Slide 10: ZGN-1061 No D-Dimer or Other CV Safety Signals
ZGN-1061 No D-Dimer or Other CV Safety Signals • No meaningful elevations in mean D-dimer concentrations across the dosing groups compared to baseline or placebo • D-dimer level increases are indicative of pro-thrombotic effect with prior MetAP2 inhibitor, which demonstrated frequent significant inc
Slide 11: ZGN-1061 in Combination with Liraglutide Reduces Body Weight in DIO Rat Model
ZGN-1061 in Combination with Liraglutide Reduces Body Weight and Improves Glycemic Control in Diet Induced Obesity (DIO) Rat Model Study Design • Randomized 5 week once-daily SC treatment with either 0.3 mg/kg ZGN-1061, 0.4 mg/kg liraglutide, a combination treatment of ZGN-1061 + liraglutide, or veh
Slide 12: ZGN-1061 Demonstrates Improved Metabolic Parameters in Biopsy-Confirmed DIO-NASH Mouse Model
ZGN-1061 Demonstrates Improved Metabolic Parameters in Biopsy- Confirmed DIO-NASH Mouse Model Study Design • DIO nonalcoholic steatohepatitis (DIO-NASH) mice were randomized to receive once daily SC treatment with 0.06 mg/kg ZGN-1061, 0.3 mg/kg ZGN-1061, or vehicle (5% mannitol) for 37 weeks prior t
Slide 13: Conclusions
Conclusions Phase 2 Proof-of-Concept Clinical Trial • ZGN-1061 met all primary endpoints at 0.9 mg dose • Highly statistically significant A1C lowering with 0.9 mg dose • Progressive reduction in A1C with no evidence of a waning effect • Consistent and meaningful biomarker improvements in FGF21, adi
Slide 14: ZGN-1061 Next Steps in 2018
ZGN-1061 Next Steps in 2018 • Complete remaining ongoing six / nine month toxicology studies • Submit IND to FDA • Progress 1.8 mg cohort • To understand efficacy of full target engagement • Patient dosing recently initiated • Further explore positive liver effects in additional nonclinical models •
Slide 15: 2018 Pipeline Milestones
2018 Pipeline Milestones Program Milestones Timing ZGN-1061 for type 2 • ADA abstract presentations June diabetes • Ph 2 core proof-of-concept data Mid-2018 • IND allowance for future clinical trials * 4Q 2018 ZGN-1258 for rare • IND-enabling studies initiation 1Q 2018 metabolic disease • Natural hi