Clearside Biomedical's CLS-AX Phase IIb Trial Readout Anticipated in Q3 2024
核心洞察
Clearside Biomedical (搜索) anticipates primary data readout from its Phase IIb ODYSSEY trial of CLS-AX for wet AMD (搜索) in Q3 2024, assessing its potential as a maintenance therapy.
The company's SCS Microinjector continues to demonstrate benefits in suprachoroidal drug delivery, with multiple partnerships and clinical trials underway for various indications.
A new collaboration with BioCryst Pharmaceuticals will utilize Clearside's SCS Microinjector to deliver their compound aboard Elestat for treating diabetic macular edema (搜索).
Clearside Biomedical (搜索) is on track to release primary data from its Phase IIb ODYSSEY trial for CLS-AX in wet age-related macular degeneration (AMD) in the third quarter of 2024. The company's focus remains on advancing CLS-AX as a long-term maintenance therapy for wet AMD (搜索) patients, leveraging its patented suprachoroidal injection technology. The ODYSSEY trial aims to replicate the safety profile, vision stability, and reduced injection frequency observed in the OASIS extension study.
Suprachoroidal Delivery Advancements
Clearside Biomedical (搜索) continues to champion the benefits of drug delivery into the suprachoroidal space using its SCS Microinjector device technology. Multiple licensing partners are making progress in their clinical development programs, with four assets currently in clinical trials for five different indications. The company highlighted a real-world analysis of Xiidra usage, which demonstrated that over 75% of eyes did not require retreatment for six months after a single dose, supporting the potential for extended small molecule drug release via suprachoroidal delivery.
New Collaboration with BioCryst Pharmaceuticals
Clearside Biomedical (搜索) announced a new collaboration with BioCryst Pharmaceuticals to utilize its SCS Microinjector for delivering BioCryst's proprietary plasma kallikrein inhibitor, aboard Elestat, to treat diabetic macular edema (搜索) (DME). The agreement includes an upfront license fee of $5 million, potential milestone payments of $77.5 million, and tiered single-digit royalties on net product sales. Clinical work is targeted to begin in 2025.
Financial Update and Outlook
As of December 31, 2023, Clearside Biomedical (搜索)'s cash and cash equivalents totaled approximately $29 million. A subsequent registered direct offering of stock and warrants generated $15 million in gross proceeds. The company believes these combined resources will fund planned operations into the third quarter of 2025, supporting the anticipated data readout for the ODYSSEY trial and planning for the CLS-AX Phase III program.
SCS Microinjector Safety Profile
Clearside Biomedical (搜索) emphasized the positive safety profile of its SCS Microinjector, with over 2000 injections performed to date. The company believes that compartmentalized drug delivery in the suprachoroidal space minimizes the risk of toxicity and interference with vision. Regeneron bio's wet AMD (搜索) clinical trial, utilizing Clearside's SCS Microinjector, reported zero cases of inflammation with only seven weeks of prophylactic topical steroids, contrasting with other gene therapies using intravitreal delivery that required more extensive steroid treatments.