Asarina Pharma AB (publ) — Technical Presentation (April 2020)
23 slides from Asarina Pharma AB (publ)'s technical presentation, Apr 22, 2020
Slide 1: TLR Presentation 22nd April 2020
ASARINA PHARMA REMAIN IN CONTROL OF YOUR LIFE TLR Presentation 22nd April 2020 1
Slide 2: Disclaimer
Disclaimer • This presentation and the information contained herein (the "Presentation") does not constitute or form part of, and should not be construed as, an offer of invitation to subscribe for, underwrite or otherwise acquire, any securities of Asarina, nor should it or any part of it form the
Slide 3: Phase IIb top-line result presentation
Phase IIb top-line result presentation • Introduction – Dr Peter Nordkild, CEO • The PMDD study top-line results - Karin Ekberg, COO • Q&A 3
Slide 4: Introduction: Peter Nordkild, CEO
Introduction: Peter Nordkild, CEO • Physician by training • 13 years in senior management at Novo Nordisk • 6 years in corporate management at Ferring • Danish serial biotech entrepreneur as founder or co-founder of 4 Danish biotech companies 4
Slide 5: Portfolio Approach to Women's Health & Neurology
Portfolio Approach to Women’s Health & Neurology Sepranolone – Remain in Control of Your Life PMDD Menstrual Tourette’s Migraine Innovative customer centric products Chronic conditions Large markets 5
Slide 6: The PMDD Clinical Phase IIb Study top-line results
The PMDD Clinical Phase IIb Study top-line results Karin Ekberg, COO PhD, experience from clinical and pre- clinical project management within biotech companies active within diabetes and cognitive impairment. 20+ years of experience in human experimental and clinical scientific work at Karolinska I
Slide 7: Phase IIb Clinical Study Design
From Asarina Pharma’s R&D Event 26 March 2020 Phase IIb Clinical Study Design A randomised, double-blind, placebo-controlled, parallel-group, multicentre study investigating the efficacy and safety of Sepranolone (UC1010) in patients with PMDD 2 cycles 3 cycles 1 cycle baseline / diagnosis treatment
Slide 8: The PMDD Diagnosis
From Asarina Pharma’s R&D Event 26 March 2020 The PMDD Diagnosis Example from a patient’s diary, showing daily ratings of the depressive symptoms during two cycles of diagnostic screening Depression The diagnosis is very strict and requires that the patient • is essentially symptom free pre-ovulator
Slide 9: Daily Record of Severity of Problems (DRSP)
From Asarina Pharma’s R&D Event 26 March 2020 Daily Record of Severity of Problems (DRSP) 24 DRSP questions, representing 11 symptoms and 3 impairment aspects, all rated from 1 “not at all” to 6 “extreme” Q1 1a Felt depressed, sad, “down”, or “blue” Q2 1b Felt hopeless Cardinal symptoms Q3 1c Felt w
Slide 10: Total Symptom Score – Primary Variable
From Asarina Pharma’s R&D Event 26 March 2020 Total Symptom Score – Primary Variable The late luteal phase Total symptom score (Lmax Sum21) is is the sum of symptom severity for all 11 symptoms. The score is calculated as the average of Sum21 for the 5 consecutive days with the highest score during
Slide 11: 4 key metrics to measure efficacy of Sepranolone
From Asarina Pharma’s R&D Event 26 March 2020 Phase IIb Clincial Study 4 key metrics to measure efficacy of Sepranolone ü Total symptom score (primary end-point) Statistical difference Lmax Sum21 and sufficiently large effect driven by effect on the most relevant symptoms, i.e. the … ü Cardinal symp
Slide 12: Phase IIb Clinical Study Patient Population
Phase IIb Clinical Study Patient Population Enrolled women Nürnberg 476 Berlin Frankfurt UK Essen 270 Screen failures i.e. did not meet DE Karlsruhe criteria for participation Krakow Elblag Patients randomized Katowice 206 SE PL Stockholm Stoke-on-trent London 4 WC, never started Liverpool treatment
Slide 13: Phase IIb Clinical Study Patient Population
Phase IIb Clinical Study Patient Population • 202 patients started treatment (APT, safety population) - 192 patients in the ITT population ITT = all patients who had completed at least one confirmed ovulatory treatment cycle and had evaluable DRSP data in that cycle - 80% of all APT completed all th
Slide 14: Injections and Dosing
Phase IIb Clinical Study Injections and Dosing Sepranolone Injections 0.4 mL prefilled in a single use syringe for patients self administration Two strengths Sepranolone (10 and 16 mg per dose) or placebo - treatment start 14 days prior to next estimated menstruation start - every second day during
Slide 15: Adverse events
Phase IIb Clinical Study Adverse events • No treatment related Serious Adverse Events has been reported • In total 236 probably/possibly related Adverse Events were reported - The vast majority were mild and transient, none was severe - No single type of general adverse event occurred in more than 3
Slide 16: Baseline
Phase IIb Clinical Study Baseline • Baseline late luteal phase symptom scores in the ITT population (N=192) Sepranolone Sepranolone Placebo 10 mg 16 mg Total symptoms (Sum21) 82.4±15.5 87.1±18.8 85.1±17.2 Cardinal symptoms 33.2±6.1 35.1±8.0 34.8±6.3 Impairment score 12.7±2.3 13.2±2.7 13.1±2.5 averag
Slide 17: Treatment effect
Phase IIb Clinical Study Treatment effect • Late luteal phase symptom scores in the ITT population (N=192) DRSP points 90 80 Active Baseline 70 Active treatment 60 Placebo Baseline Placebo treatment 50 40 30 20 10 0 Total symptoms Sum21 Cardinal symptoms Impairment score 17
Slide 18: Treatment effect
Phase IIb Clinical Study Treatment effect • Improvement in late luteal phase symptom scores from baseline in the ITT population (N=192) Sepranolone Sepranolone Difference Active vs. Placebo 10 mg 16 mg Active-Placebo Placebo Total symptoms (Sum21) 30.5±22.2 30.0±20.2 27.9±21.4 2.4±21 NS (p=0.3) Card
Slide 19: Treatment effect
Phase IIb Clinical Study Treatment effect • Improvement in late luteal phase symptom scores in the ITT population (N=192) DRSP points Active treatment Placebo treatment 6 5 4 3 2 1 0 ty i ty n ed ue y i te p y l n a et lit ee io io sic li ig iv lm et bi at s bi xi Sl es t y t p An La he ita Fa tr Ac
Slide 20: In Conclusion
Phase IIb Clinical Study In Conclusion • The baseline data show that the intended patient population was recruited - Stricter inclusion criteria produced a well defined patient population • Sepranolone did not met the primary or secondary end-points - Placebo effect high and with large variance - Th
Slide 21: Asarina Pharma and PMDD
Asarina Pharma and PMDD • Throughout the study we have built up great links with PMDD patients groups and organizations and we will share the results from the study with them • We hope that our research around allopregnanolone will play an important part in the collective understanding of PMDD • Wit
Slide 22: Asarina Pharma next steps - the case for Sepranolone remains
Asarina Pharma next steps - the case for Sepranolone remains • We know that ALLO is a powerful neurosteroid with a high impact, and that ALLO levels are elevated in the brains of patients with a wide range of stress-related conditions • We know that Sepranolone reduces symptoms induced by elevated l
Slide 23: Thank you for attending!
» ASARINA PHARMA Thank you for attending!