TOXINS 2024: Results from Ipsen’s AboLiSh study demonstrate the significant clinical benefit of using injection guidance techniques when treating spasticity with abobotulinumtoxinA

• AboLiSh is the first global study to demonstrate the clinical benefit of using injection guidance techniques to improve patient goal attainment
• Analyses of study data indicated that patients who are administered treatment with Dysport^® (abobotulinumtoxinA) with the use of injection guidance techniques are nearly 3 times more likely overall to achieve their goals
• The study highlights that almost 1 in 4 clinicians are not using injection guidance when administering abobotulinumtoxinA

PARIS, FRANCE, 19 January 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today top line results from its real-world AboLiSh study (NCT04050527), presented at the 7^th international TOXINS conference in Berlin, Germany. The study evaluated utilization and effectiveness of Dysport^® (abobotulinumtoxinA) in people living with lower-limb spasticity and found that injection guidance techniques significantly help to improve outcomes and goal attainment in patients.

AboLiSh was a prospective 16-month observational study with a primary endpoint of goal attainment measured by subject centred Goal Attainment Scaling-Leg (LegA) T score. Topline results demonstrated statistically significant improvement in rehabilitation goal attainment in instances where physicians used guidance techniques, such as ultrasound, electrostimulation, electromyography or a combination of techniques, to deliver the first cycle of treatment to patients, compared to those receiving treatment without the use of guidance techniques. Patients who received abobotulinumtoxinA (AboBoNT) injections with the support of injection guidance were nearly 3 times (2.7) more likely overall to achieve their rehabilitation goals.

The AboLiSh study, which assessed 430 patients in 9 countries in Europe, the Americas, Australia and Russia, found that while the majority of clinicians already use guidance techniques, almost 1 in 4 clinicians (23%) administered AboBoNT without guidance, which was associated with reduced goal attainment and could lead to negative consequences, including patient adherence to neurotoxin injections.

“These findings highlight a current lack of consistency in how treatment is being administered to patients and underpin the importance of real-world evidence to inform clinical practice”, said Dr Alberto Esquenazi MD, Director Gait & Motion Analysis Laboratory at Jefferson Moss-Magee Rehabilitation in Philadelphia. “It is crucial that we consistently and routinely use our clinical assessment skills and the injection guidance tools available to us to ensure patients achieve their goals and their treatment is optimized.”

Ipsen is committed to further improving patient care for people living with spasticity and the study findings will be used to support Ipsen’s ongoing work to support the training of clinicians on the use of neurotoxin injections for the treatment of spasticity.

“We want to do our part to ensure those receiving treatment with Dysport have access to the best standards of care and are given every opportunity to achieve their goals.” says Sandra Silvestri, Chief Medical Officer, Ipsen. “To help facilitate this we are greatly expanding our Ixcellence program for neurology and rehabilitation specialists in 2024 which will utilize our global network of expert trainers to provide advanced education and knowledge transfer across a broad range of techniques essential to improving outcomes in patients with post stroke spasticity, including anatomy, ultrasound and goal setting.”

Clinicians taking part in the study were not given a protocol for the use of guidance techniques allowing them to treat patients in accordance with their standard practice. Results were determined using a cumulated (mean) Goal Attainment Scaling-Leg (LegA) T score, measuring the difficulty in passive and active muscle function following therapeutic intervention, across treatment cycles for each individual patient. No new safety signals were identified during the trial.

ENDS

About the AboLiSh Study

The AboLiSH study (NCT04050527) is a prospective, international, longitudinal real-life clinical observational study. The objective is to assess the longitudinal attainment of person-centered and function-related goals after one or more abobotulinumtoxinA injections in the lower limb over 16 months in a real-life clinical setting.

About Spasticity

Spasticity is estimated to affect more than 12 million people worldwide.¹ It is a condition in which certain muscles are continuously contracted causing stiffness or tightness of the muscles, which can interfere with normal movement, gait and speech.^2–3 Spasticity is usually caused by damage to the parts of the brain or spinal cord that control voluntary movement,² leading to a change in the balance of signals between the nervous system and the muscles which leads to increased activity in the muscles. Spinal cord injury, multiple sclerosis, cerebral palsy, stroke, brain or head trauma and metabolic diseases can all cause spasticity.³ Spasticity is experienced by approximately 34% of stroke survivors within 18 months following a stroke.⁴

About Dysport

Dysport^® (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in more than 90 countries, more than 30 years of clinical experience and 6 million treatment years of patient experience.
The detailed recommendations for the use of Dysport are described in the Summary of Product Characteristics (SmPC) for Dysport (300 units) Powder and Dysport (500 units) Powder, and the U.S. Prescribing Information (PI).
NOTE: Dysport^® labels and approved indications may vary from country to country.

About Ipsen

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.

Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.
  

Ipsen contacts

• Charlotte Davies | +44 (0) 7514 728359 | Charlotte.Davies@ipsen.com
• Sandra Hobson | + 447823661957 | Sandra.Hobson@bcw-global.com

Disclaimers and/or Forward-Looking Statements

The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com.

¹ John Hopkins Medicine. Spasticity. Accessed: December 2020. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/spasticity. Accessed December 2020.

² American Association of Neurological Surgeons. Spasticity. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed December 2020

³ American Association of Neurological Surgeons. Movement Disorders. Available at: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Movement-Disorders. Accessed December 2020.

⁴ Kuo C. Post-stroke Spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol 2018;12:280-284.

Attachment

• Ipsen PR_AboLiSh TOXINS_19012024