Ipsen’s LANTIC Phase II in aesthetics delivers a first-in-class, differentiated long-acting clinical profile for IPN10200, enabling the initiation of Phase III
Summary by AI BETAClose X
- IPN10200 is a recombinant, first-in-class molecule uniquely engineered to generate increased receptor affinity and internalization that produces a longer duration of action, optimized for safety and efficacy
- Data showed a rapid onset of action, peak effect superior to placebo, and a substantial majority of patients experiencing clinically significant longer duration of effect vs placebo and vs Dysport, defined as a score of “none” or “mild” of line severity at Week 24
- Data to be presented at upcoming scientific conference in H1 2026 and Phase III start-up activities initiated
- Phase II development continues for therapeutic indications including adult upper limb spasticity, migraine and cervical dystonia
PARIS, FRANCE, 22 September 2025 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced the first aesthetic data (n=183) for glabellar lines with internally developed IPN10200, following Stage 1 of the multi-stage, ongoing Phase II LANTIC trial. Patients treated with IPN10200 showed a statistically significant improvement in response at Week 4 vs placebo (primary endpoint). A longer duration of effect was also observed with a substantial majority of patients experiencing a clinically significant response at Week 24 compared with placebo and Dysport, defined as a score of “none” or “mild”. IPN10200 continued to show a greater response in line severity vs Dysport at Week 36. In this trial Dysport was shown to perform consistently with its profile.
“The data demonstrates that we have a first-in-class, unique molecule with the potential to be a breakthrough innovation in aesthetics, demonstrating truly longer duration versus an established botulinum A for glabellar lines,” said David Loew, CEO of Ipsen. “Today’s announcement is an important milestone for Ipsen as we advance our pipeline and underscores our commitment and expertise, built on a more than 30-year legacy in Neuroscience.”
“IPN10200’s novel design, derived from active sequence part A and binding sequence part B, is optimized for safety and efficacy. Uniquely engineered to deliver increased receptor affinity and internalization IPN10200 has shown this clinically significant long duration of effect, experienced for the first time by a substantial majority of patients at Week 24.” said Christelle Huguet, PhD, EVP and Head of R&D, Ipsen. “These data are reinforced by the rapid onset of action and superior patient satisfaction scores vs placebo and vs Dysport. We are committed to advancing science with purpose to bring the benefits patients are looking for, as we believe everyone deserves a life fully lived.
IPN10200 has shown a statistically significant improvement in response compared to placebo, as measured by the primary endpoint of composite response of 2-grade improvement on both Investigator and Subject assessment of line severity at Week 4, consistent with peak effect observed with Dysport. A longer duration of effect was also observed with a substantial majority of patients experiencing a clinically significant response, defined as a score of “none” or “mild” as measured by Investigator assessment of line severity, at Week 24 compared with placebo and with Dysport. Patient diary data showed a rapid onset of action with IPN10200.
IPN10200 was shown to be well-tolerated with no safety concerns reported with any of the evaluated doses of IPN10200 across Stage 1. Data will be shared in a scientific conference in the first half of 2026 and activities for our global Phase III program in glabellar lines have been initiated. The LANTIC trial remains ongoing, with Stage 2 currently recruiting patients to evaluate the efficacy and safety of IPN10200 compared with placebo in forehead lines or lateral canthal lines.
About IPN10200
IPN10200 is Ipsen’s first-in-class recombinant molecule, uniquely engineered to combine active sequence part A and binding sequence part B. Designed for enhanced receptor affinity and internalization, IPN10200 delivered a longer and clinically significant duration of effect. The molecule has been optimized for safety and efficacy and is being evaluated across four Phase II trials in both aesthetic and therapeutic indications.
About LANTIC
LANTIC (n=727) a Phase I/II trial evaluating the safety and efficacy of IPN10200 in three aesthetic indications of moderate to severe upper facial lines: glabellar lines, forehead lines and lateral canthal lines, across 3 Stages. Stage 1 includes patients evaluating safety and efficacy of IPN10200 in a dose finding and dose escalation stage in glabellar lines, with three defined steps including multiple doses of IPN10200; dose-escalation (step 1: Phase Ib), dose finding vs placebo and vs Dysport (step 2: Phase II) and additional dose finding vs placebo and vs Dysport (step 3: Phase II). Different doses of IPN10200 were evaluated within each step. Step 3 is the basis of the proof-of-concept data for IPN10200 in glabellar lines including 183 patients. Stages 2 and 3 (Phase II) will evaluate IPN10200 in all three upper facial indications vs placebo. The LANTIC trial is one of several ongoing trials within Ipsen’s broader IPN10200 development programs.
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 internal and 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
Investors
Henry Wheeler henry.wheeler@ipsen.com +33 7766471149
Khalid Deojee khalid.deojee@ipsen.com +33 666019526
Media
Sally Bain sally.bain@ipsen.com +1 8573200517
Anne Liontas anne.liontas.ext@ipsen.com +33 0767347296
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 and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; 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.
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