Liposphere presented its AqueousJoint knee joint injectable at the Alliance for Advanced Therapies in Orthopedics (ATiO, https://atioalliance.org/) conference in Berlin. Following competitive rounds of presentations, the Company won the Best Early-Stage Company award judged by a high-profile orthopedic audience and received the „Dancing Bear“ trophy.

The Israeli Ministry of Health approved our efficacy-focused clinical trial protocol. The trial will be a multi-center, double-blinded, and randomized study, and the primary outcome is to show the superiority of the CCoat product compared to a saline solution (Placebo). Moreover, low, and high dosages of Coat by Liposphere will be used to identify the optimum product concentration.
Each group will recruit 50 patients to achieve statistically meaningful results.
The first clinical site in Assuta Hospital, Ashdod, was initiated. Further sites are Kaplan Hospital, Rehovot, Tel-Hashomer, Ramat-Gan, and Asaf Harofe Beer-Yacov, which will open soon to expedite recruitment.

20 Patients with diagnosed Osteoarthritis were enrolled in our First-In-Human safety trial in which the AqueousJoint product was clinically evaluated for the first time. Those patients received a single AqueousJoint injection into their knee joint cavity.
A follow-up time of 6 months was completed successfully, confirming the product’s safety (no related adverse events reported) and a long-lasting pain reduction effect of 6 months. The efficacy output was assessed using standardized questionnaires: The Knee Injury and Osteoarthritis Outcome Score (KOOS) and a Numeric Visual Scale (NVS) measure.

The clinical batch production for the next clinical trial is under way. Liposphere built its own in-house clean room manufacturing facility for production. For the production of these current clinical batches, the Company upscaled the fabrication of the material substantially.

In a joint effort involving significant contributions by the AO Research Institute Davos, the AO and Liposphere will exploit the unique properties of this technology, which promises to alleviate the burden of Osteoarthritis.
This collaboration is funded by the AO’s Development Incubator, which provides expertise and in-kind support to navigate the regulatory challenges on the way to the product’s CE-marking.

The Israel Innovation Authorities continue to support Liposphere’s path towards commercialization of its knee joint injectable AqueousJoint in its 4th year. Thank you IIA for being such a great partner!

Data that we gathered over the past years on the preclinical in-vivo safety of AqueousJoint has been published in Toxicologic Pathology! Congratulations to the authors!

We are very excited to announce that we have moved to the clinical phase! The first patients of the First-In-Human trial, conducted in two leading Israeli hospitals, have been injected intra-articularly with our knee joint articulation compound AqueousJoint. The primary outcome of this first clinical study is safety of the formulation.

Weifeng Lin, Ronit Goldberg and Jacob Klein jointly published a paper in Journal of Materials Chemistry B demonstrating dramatically prolonged retention times of pMPCylated liposomes following intra-articular injection in mice joints. Congratulations!

Liposphere manufactured its first clinical batch of AqueousJoint. Liposphere’s new injectable will be evaluated clinically in First-In-Human trials in Ichilov Hospital Tel Aviv over the next months. How exciting!

Liposphere with its AqueousJoint development project was chosen to join the IDEA2 program and participated in workshops throughout 2021. IDEA2 is a program based at the Massachusetts Institute of Technology. It provides transformative mentorship and expertise to emerging innovation leaders to develop their project ideas.

We are happy to announce that Vered Yanai joined Liposphere as the Companies Head of Quality Assurance. Vered brings a wealth of knowledge in developing and implementing Quality Assurance. She supports Liposphere’s R&D team to develop study protocols, validation reports, working procedures and techniques according to the constantly progressing regulatory environment.

Dr Asaf Grupi was appointed to serve as Liposphere’s Chief Scientific Officer. Asaf holds a PhD in Physics from Bar-Ilan University. He brings extensive experience in analytical method development and validation techniques as R&D management skills to accelerate product development.

We are excited to share that Liposphere will participate in the 2021 MassChallenge Israel accelerator program. Liposphere was chosen to be part of the Nanotechnology and MetaMaterials track run in collaboration with IAI-ELTA Systems.

After a few months of building work, we successfully relocated into our purpose-built facility with a dedicated clean room for developing and manufacturing biolubricants for intended human use.

Congratulations to Prof Jacob Klein, Ronit Goldberg and team for this remarkable achievement! Enjoy the read!

https://science.sciencemag.org/content/370/6514/335

Within the upcoming year, we will complete the preclinical experiments and ultimately manufacture cGMP batches in-house for First-In-Human studies. Therefore, we are setting up a new facility to fulfill this task according to the required standards.

We successfully accomplished a first production of our orthopaedic product AqueousJoint after design-freeze earlier this year. We have started preclinical experiments with this formulation and are beginning to see promising results!

The Spinoff Prize 2020 has highlighted Liposphere as one of the 44 most
exciting, science-based start-ups spun out from academic settings. A “One to Watch 2020”! The Spinoff Prize 2020 was established by Nature Research in partnership with Merck KGaA to showcase and celebrate global excellence in
the commercialization of research through the creation of spin-off companies.