AEON Biopharma, Inc. presented new clinical and pre-clinical data for ABP-450 in treating cervical dystonia (CD) and posttraumatic stress disorder (PTSD) at TOXINS 2024, a leading conference held by the International Neurotoxin Association (INA) from January 17th - 20th at the Estrel Berlin in Berlin, Germany. Cervical Dystonia OLE Phase 2 Data: A poster titled, ?Efficacy and Safety of ABP-450 (prabotulinumtoxinA) in Adults with Cervical Dystonia: Results From the Open-label Extension of a Phase 2 Trial,? was presented by Chad Oh, M.D., the Company?s Chief Medical Officer.

Topline data from the recently completed open-label extension (OLE) of the Phase 2 trial demonstrate that ABP-450 was generally safe and well tolerated in CD patients for up to 4 treatment cycles during the 52-week duration of the study. ABP-450 did not appear to increase treatment-related TEAEs at any dose in the study. Peak efficacy for all ABP-450 doses and cycles occurred early, within 4 weeks, and durability of effect was demonstrated from 12 to 16 weeks post treatment.

These results support further investigation of ABP-450 as a treatment option for patients with CD and other movement disorders. The OLE was a 52-week study of ABP-450 in adults with moderate to severe CD, a chronic and debilitating neurologic condition affecting the muscles of the neck, who participated in the placebo-controlled, double-blind Phase 2 (DBP) study and for whom =8 weeks had elapsed between their single DBP treatment and first OLE treatment. Patients who showed a lack or loss of efficacy at DBP Week 4 or later could transition to the OLE (after 8 weeks had elapsed for patients transitioning prior to Week 8); otherwise, patients entered the OLE at Week 20, providing they met the entry criteria.

Patients received up to 4 treatments of ABP-450 during the OLE; patients received a dose range of 115 to 350 units as determined by and at the discretion of the investigator. After the first OLE treatment, patients were eligible for retreatment when their Toronto Western Spasmodic Torticollis rating scale total score (TWSTRS-T) returned to =20 and =10 weeks had passed since their last dose of ABP-450. Pre-Clinical PTSD Data Utilizing Stellate Ganglion Block: During TOXINS 2024 conference, Dr. Chad Oh also presented a poster titled, ?New Investigations of Stellate Ganglion Block (SGB) with ABP-450 (PrabotulinumtoxinA) in Rats.?

This poster reports new data from three pre-clinical studies showing right or left SGB, ABP-450 appeared to be safe and well tolerated, with no significant signs of toxicity observed. The stellate ganglion (SG) is formed by the fusion of the sympathetic ganglia in the upper thorax and provides most of the sympathetic innervation to the head and body. The three pre-clinical studies utilized SGB to injected rats with ABP-450 (0.5 or 3 units) both individually and in conjunction with lidocaine (1%-2%) using an ultrasound-guided technique over a duration of 1 to 2 hours.

For the SGB procedure, baseline recordings of physiological parameters were assessed (i.e., heart rate, eye appearance, and pupil size) and then the linear ultrasound transducer (FUJIFILM Vevo 3100 micro-ultrasound imaging system) was placed in a short axis view proximal to the clavicle. After identifying the lateral side of the cephalic brachial vein, a 27-gauge needle connected to an insulin syringe (0.5 mL) was advanced from the lateral to medial stellate ganglion (SG) to deliver lidocaine and/or ABP-450. Both lidocaine and ABP-450 were mixed with Chicago blue dye to confirm SGB targeting.

Based on the results of this study, an appropriate dose for ABP-450 injected into the rat SG appears to be between 1 and 10 U/kg. The primary indicator for SGB (ptosis as a manifestation of the Horner?s syndrome) was clearly established and verified parenteral delivery of lidocaine to both the left and right SG, suggesting that left side and/or bilateral dosing is an option for future experiments. This early-phase, original research in a limited dataset illustrated the successful implementation of an imaging-guided SGB model using lidocaine.

These results provided pilot data confirming the accurate delivery of combination doses of lidocaine and ABP-450, with evidence of appropriate SGB targeting without significant signs of toxicity, which supports future studies of ABP-450 as a potential treatment of PTSD.