BNT23001 Next-Gen Solution for Multiple sclerosis (MS)

Revolutionizing MS Treatment with Sublingual Cladribine

BNT23001, BioNxt’s innovative sublingual Cladribine film, is designed to transform how patients with multiple sclerosis (MS) manage their treatment. Leveraging advanced oral dissolvable film (ODF) technology, BNT23001 provides a convenient, fast-acting, and patient-friendly solution that addresses a critical gap in the MS treatment landscape.

Why BNT23001?

• Enhanced Patient Compliance: Many MS patients face challenges with traditional oral medications due to swallowing difficulties. BNT23001’s dissolvable film format eliminates the need to swallow, enhancing comfort and ease of administration.
• Faster Absorption and Bioavailability: Our sublingual delivery bypasses the gastrointestinal tract and first-pass liver metabolism, leading to faster onset and improved bioavailability of Cladribine. This efficiency can result in lower, more effective doses and potentially reduce side effects.
• A Proven Therapeutic: Cladribine has a strong track record in MS treatment worldwide, approved by both the FDA and EMA for its efficacy in reducing relapses. BNT23001 harnesses this established therapeutic while enhancing its delivery for maximum patient benefit.

Targeting a Growing Need in MS Treatment

With a market estimated at $28 billion, MS represents a high-impact area where improved therapies are urgently needed. Over 2.8 million people worldwide live with MS, many of whom struggle with swallowing issues that can affect adherence to traditional treatments. BNT23001’s sublingual film is specifically developed to meet this need, offering MS patients an easier way to receive their treatment.

Product Features

• Convenient & Portable: The compact, flexible film is ideal for on-the-go dosing, giving patients flexibility in managing their condition.
• Rapid Dissolution: The film dissolves quickly under the tongue, delivering the medication directly to the bloodstream.
• Minimally Invasive: Unlike injectables, BNT23001 provides a non-invasive alternative, improving the patient experience.
• Clinical Efficacy: Designed to match the efficacy of traditional Cladribine tablets, with added benefits in bioavailability and ease of use.

Next Steps for BNT23001

BioNxt is advancing toward a bioequivalence study in Q1 2025, following rigorous pre-clinical and pharmacokinetic studies. Upon successful completion, we will proceed with scaling up manufacturing in collaboration with our research partners to bring BNT23001 to the MS community.

Learn More About BNT23001

For more information on BNT23001 and how BioNxt is committed to advancing MS treatments, please contact us or follow our progress through regulatory milestones. Together, we are making strides to enhance the quality of life for those living with multiple sclerosis.