Introducing a new standard of topical therapies - Jesper J. Lange, President & CEO Dermatology Summit 2019 - Company Presentation ...
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PAD™ Technology - releasing the full potential
Introducing a new standard of topical therapies
Jesper J. Lange, President & CEO
Dermatology Summit 2019
© mc2 therapeutics ÷ 1
Attractive topical therapies for chronic conditions must meet three criteria
Actives Formulation Compliance
Safe and potent Optimal delivery Patients want to
to target tissue use product in
daily routines
Releasing full clinical potential
© mc2 therapeutics ÷ 2
Challenging status quo - introducing PAD™ Technology – a new standard in topicals
Efficacy Status quo:
Optimal real-life
Efficacy or compliance?
efficacy and comfort
Combining high efficacy
PAD™
Paradigme and
High Vehicles
shift excellent cosmetic feel
Ointment,
liquid oil
Cream, lotion,
spray, gel,
Low foam
Comfortable in daily routines
= increased compliance
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Low High
PAD™ Technology – developed for optimal efficacy and compliance - redefining topicals
PAD™ Key Feature Impact
Optimal delivery of API’s Strong clinical data
Increasing quality of life and
Pleasant and tolerable
compliance
Expanded formulation Enables difficult API’s in
space topical therapies incl. combos
Granted patents
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PAD™ tacrolimus formulation is more effective and yet uniquely elegant
PAD™ Vehicle delivers more tacrolimus to PAD™ tacrolimus outperforms Protopic®
minipig skin than Protopic® ointment in allergic contact dermatitis pig model
2000 3.00
1800
ng tacrolimus / g tissue
1600 2.50
1.3x
1400
Erythema score
2.00
1200
3x
1000 1.50
800
600 1.00
400 PADtacro
0.50
200 Protopic
0 -
PAD™ Veh 0.03% PAD™ Veh 0.1% Protopic® ointment
0.1% 0.001 0.01 0.1
Concentration (% w/w) [log scale]
(Biopsy data from minipigs treated twice daily for 4 weeks show penetration at (Allergic contact eczema induced by sensitization/challenge with DNFB/DNCB.
least comparable to the reference Protopic® ointment; n=4, two test Erythema scoring 24h after challenge and treatment at 30 min and 6h; n=8,
areas/biopsies per formulation per animal) two test areas per formulation per animal)
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PAD™ is releasing the full potential – also on difficult actives
§ Formulation of NCE under third party collaboration
§ PAD™ Vehicle outperformed third party competing formulations in landrace pig allergic contact dermatitis model
Target efficacy profile PAD™ formulation
for NCE drug rescued program as
candidate conventional formulations
Ointment Control
Ointment Vehicle
Betamethasone
Hydrocortisone
Ointment 0.1%
did not succeed
Cream 0.1%
PAD™ 0.1%
Clobetasol
butyrate
(Allergic contact eczema induced by sensitization/challenge with DNFB/DNCB.
Erythema scoring 24h after challenge and single treatment at 30 min; n=9)
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PAD™ eye drop enables >4x better delivery of ciclosporin vs. Restasis®
Single dose PK in rabbits (cornea)
3000
PADciclo (0.1%)
2500 PADciclo (0.06%)
ng CsA/g cornea tissue
Restasis® (0.05%)
2000
1500
1000
500
4.7x fold AUC0-24h
0
0 4 8 12 16 20 24
Hours
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MC2-03 (dry eye) Ph2 trial: PAD™ enables strong clinical efficacy data on ciclosporin
Combined arms Combined arms
% Treatment success % Treatment success
Severe patients subgroup
80% 80%
0.03% + 0.06% CsA 0.03% + 0.06% CsA
70% 70%
% CFS 2-grade responders
Vehicle + Lubricant Vehicle + Lubricant
% CFS 2-grade responders
60% 60%
50% p=0.0358 p=0.0161
50%
40% 40%
30% 30%
20% 20%
10% 10%
0% 0%
n=50 n=48
Month 3 Month 6 Month 3 Month 6
n = 111 - 119 per arm n = 48 – 51 per arm
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Topline data US Ph3 Trial on MC2-01 PAD™ Cream (plaque psoriasis)
Head-to-head trial against Taclonex® Topical Suspension
MC2-01 0.005% w/w calcipotriene + 0.064% w/w betamethasone dipropionate cream
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Rationale: Improve the best topical therapy for psoriasis (fixed-dose CAL/BDP)
Calcipotriene (CAL) Betamethasone diproponate (BDP)
Dual synergy: PAD™ Technology uniquely enables a stable
cream formulation of CAL and BDP
1) High potent efficacy – dual MoA of CAL and BDP
1) Quickly absorbs into the skin
2) Improved safety - CAL and BDP mitigate
potential adverse effects known from mono- 2) High penetration to target tissue
therapy1
MC2-01 Cream
0.005% w/w calcipotriene and 0.064% w/w
betamethasone dipropionate
1. Norsgaard et al. Arch Dermatol Res (2014) 306:719–729
© mc2 therapeutics ÷ 11Ph3 trial to evaluate efficacy and safety of MC2-01 Cream compared to Taclonex® TS
Screening 8 week treatment period – 1x daily Follow-up
Baseline Week 8
MC2-01 cream (n~342)
Adults
mild to
R MC2-01 cream vehicle (n~115) 2 week follow-up
moderate
psoriasis
Taclonex Topical Suspension (n~337)
© mc2 therapeutics ÷ 12MC2-01 Cream demonstrates significantly higher treatment success than Taclonex® TS
Primary efficacy variable: PGA Treatment Success
50
MC2-01 Cream
****
Taclonex
40
****
% PGA Treatment Success
MC2-01 Vehicle
30 ****
20
10
**** p < 0.0001
MC2-01 vs Taclonex
0
0 2 4 6 8
Weeks
© mc2 therapeutics ÷ 13MC2-01 Cream demonstrates significantly better reduction in mPASI than Taclonex® TS
Secondary efficacy variable: Percentage Change in mPASI from Baseline
80
MC2-01 Cream
70
% Change in mPASI from Baseline
****
Taclonex ****
60
MC2-01 Vehicle ****
50
40
30 ***
20
*** p < 0.001
(MC2-01 vs Taclonex)
10
**** p < 0.0001
0 (MC2-01 vs Taclonex)
0 2 4 6 8
Weeks
© mc2 therapeutics ÷ 14MC2-01 Cream has significant PASI 75 treatment success
Other efficacy variable: PASI 75 Treatment Success
50
MC2-01 Cream
**
Taclonex
40
MC2-01 Vehicle **
% PASI 75
30
**
20
10
** p < 0.01
MC2-01 vs Taclonex
0
0 2 4 6 8
Weeks
© mc2 therapeutics ÷ 15Patients found MC2-01 cream significantly more convenient than Taclonex® TS
Secondary PRO: Patients treatment convenience scale
50
Patient Treatment Convenience Scale
MC2-01 Cream
45
Taclonex
****
****
40
****
35
**** p < 0.0001
MC2-01 vs Taclonex
30
0 2 4 6 8
Weeks
© mc2 therapeutics ÷ 16MC2-01 Cream shows significant and clinically meaningful reduction of itch
Proportion of subjects with ≥4-point improvement of itch on 11-point NRS scale
80
% ≥4-point improvement of NRS Itch
MC2-01 Cream
70 **
MC2-01 Vehicle
**
60
50
40
30
20
10 ** p < 0.01
MC2-01 vs Vehicle
0
0 2 4 6 8
Weeks
© mc2 therapeutics ÷ 17MC2 advanced pipeline targeting major chronic inflammatory conditions
Active MC2 Pre- Launch
Program Indication Phase 2 Phase 3 Filing
Ingredient Rights Clinical est.
US H1’19 US H1’ 20
MC2-01 Calcipotriene/BDP Psoriasis Worldwide
EU EU H2’19 EU H2’ 20
EU H2’ 21
MC2-03 Ciclosporin Dry Eye Worldwide
US TBD
Rx
Atopic
MC2-11 Tacrolimus Worldwide Ph2a H2’19 TBD
Dermatitis
AD and
MC2-XX Undisclosed Worldwide TBD
Psoriasis
Clinical
OTC & biocide development Launch
data
Uremic
MC2-02 Undisclosed Worldwide Q319 H2’19
Pruritus
Cosmetic /
MC2-21 Dry skin/AD Worldwide Q319 H2’19
Non- Medical Device
Rx MC2-18
Cosmetic / Contact
Worldwide Q319 H2’19
Medical Device Dermatitis
Sanitizer
MC2-10 Biocide Worldwide Q319 H2’19
sensitive skin
© mc2 therapeutics ÷ 18PAD™ Technology provides an excellent branding opportunity – new class of vehicle © mc2 therapeutics ÷ 19
Opportunity to build leadership in innovative topical therapies
for chronic inflammatory diseases
- a four step approach
© mc2 therapeutics ÷ 20Building leadership in innovative topicals for major chronic inflammatory diseases
2023 and forward
i n topicals
l eadership Optional PAD™ product portfolio
ng
Buildi • MC2-01 PAD™ (Psoriasis)
• MC2-02 PAD™ (Uremic Pruritus)
2018
• MC2-10 PAD™ (Sanitizer)
• MC2-18 PAD™ (Contact derm)
Current MC2 position Four step approach • MC2-21 PAD™ (Dry skin)
1. Access and motivate high quality sales teams • MC2-11 PAD™ (Atopic Dermatitis)
• Ambition to set a new • MC2-23 PAD™ (Atopic Dermatitis)
standard in topicals for • 2019: 4 x non-Rx (UP, dry skin, contact derm., sanitizer)
• 2020: MC2-01 PAD™ (Psoriasis) • MC2-03 PAD™ (Dry eye)
chronic inflammation • PAD™ Y? (Pso, AD, Alop., Rosacea etc.)
• PAD™ X? (Indication x)
• Late clinical stage pipeline 2. PAD™ Tech Brand awareness • PAD™ Combo Z+Y? (Indication z)
• The “New Pearl in Dermatology”
• PAD™ Tech and Know-how • Interaction with dermatologists through non-Rx
– a new standard • Excellent for SoMe campaigns • Leadership in innovative topicals for
chronic inflammatory conditions
• Fast to lead PAD™ 3. Develop and expand pipeline including NCE’s
formulations and IND • Access innovative new molecular entities (I&I) • Evidence that PAD™ topicals provide
• Partnerships on NCE’s strong cost/benefit value proposition
• Proven topical drug to patients, physicians and payers
development competences 4. Collaborate with leading stakeholders globally
> 1,500 patients in clinical
trials
© mc2 therapeutics ÷ 21PADTM Technology: Uniquely releasing the full potential of actives in the most elegant way
PAD™ Tech offers Attractive clinical profile will facilitate
uniquely expanded formulation space: strong market access
v Penetration
v Stability
v Tolerability
v Elegance and feel
v New patents
7.0
6.0
5.0
CLINICAL ENDPOINT
4.0
3.0
Active ingredients (API’s) 2.0 PAD™ Tech based products
1.0
0.0
a sustainable commercial success
Baseline Week 1 Week 2 Week 3 Week 4
TIME
PAD™ Tech releases full clinical
potential and patient satisfaction
v NCE
v 505(b)(2)
=> strongest real-life performance
v Medical Device / OTC
© mc2 therapeutics ÷ 22Company highlights – new standard of innovative topicals that patients want to use
Ambition Introduce a new standard of topical therapies for chronic inflammatory conditions
Late stage
MC2-01 (psoriasis): NDA in H1’19 + ongoing EU Ph3 MC2-03 (dry eye): Ph2 completed
pipeline
Unique brand
4 X PAD™ healthcare products (non-Rx) planned for launch in 2019
opportunity
Competitive
PAD™ Technology + Patents + substantial Know-how + strong PAD™ brand
advantage
Pipeline
Fast PAD™ formulation of lead candidates based on NCE’s, 505(b)(2) and OTC
generator
© mc2 therapeutics ÷ 23Release your full
potential
© mc2 therapeutics ÷ 24You can also read
