| |FEBRUARY 20258APOGEE DOSES FIRST PATIENT IN PHASE 2 APEX TRIAL FOR ATOPIC DERMATITISC2 PHARMA has disclosed the approval of a Certificate of Suitability (CEP) for Oxybuprocaine Hydrochloride from the European Directorate for the Quality of Medicines and Health Care (EDQM). Oxybuprocaine Hydrochloride is presently accessible to consumers in Europe and various international markets with reciprocal acknowledgment of the CEP. Oxybuprocaine Hydrochloride, commonly referred to as Benoxinate, is a man-made local anesthetic applied in ophthalmology and otolaryngology for minor surgical operations. At present, there are just two sanctioned CEPs for Oxybuprocaine HCL, and C2 PHARMA possesses the second one."Achieving this approval demonstrates our dedication to meeting the highest regulatory standards and positions us as a key player in the market for this product," states Katrien Oosterom, senior vice-president of regulatory affairs. Oxybuprocaine Hydrochloride is manufactured by C2 PHARMA's trusted CMO, Laurus Labs, at their new site in Anakapalli, India.The application for Oxybuprocaine HCL, submitted in July 2024, has been approved in a record review timeline of just seven months. It underscores the quality and compliance of this submission. "This achievement highlights our company's commitment to excellence, efficiency, and integrity, further solidifying our reputation as the trusted leader in ophthalmic APIs," states Andrew Badrot, CEO of C2 PHARMA. The CEP approval was secured on January 9th, 2025, and is officially published on the EDQM website. POApogee Therapeutics, Inc., a biotechnology firm in the clinical stage, announced that the initial patient has received treatment in Part B of the phase 2 APEX clinical trial of APG777 for individuals with moderate-to-severe atopic dermatitis (AD), and that enrollment has been finalized in Part A of the trial."Enrollment for the phase 2 Part A trial of APG777 surpassed the approximately 110 patient target ahead of schedule, driven by strong patient and investigator enthusiasm, underscoring the potential of APG777 to address the need for safe, effective treatment options that reduce injection burden and provide better disease control for patients with AD and other I&I conditions," said Carl Dambkowski, M.D., chief medical officer of Apogee. "Positive results from our phase 1 healthy volunteer trial enabled us to design this phase 2 trial whereby APG777 is modeled to exceed lebrikizumab exposures by ~30-40 percent with potential for improved clinical responses, as well as approximately half the number of injections during induction and ~70-90 percent fewer injections in maintenance compared to currently available therapies. Our uniquely designed phase 2 trial allowed us to seamlessly transition from completing enrollment in Part A to enrolling Part B within one week, streamlining the clinical development process and potentially enabling us to bring APG777 to patients sooner."APEX is a phase 2 randomized, placebo-controlled study assessing APG777, a new subcutaneous (SQ) extended half-life monoclonal antibody (mAb) that targets IL-13, an essential cytokine in inflammation and a key factor in AD, in individuals with moderate-to-severe AD. The study was aimed at merging the usual phase 2a and 2b segments of a clinical trial into one protocol. POTOP STORIESC2 PHARMA SECURES EDQM CEP APPROVAL FOR OXYBUPROCAINE HYDROCHLORIDE
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