Pharmaceutical Executive Daily: FDA has Approved Skinvive by Juvéderm

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In today's Pharmaceutical Executive Daily, Elicio Therapeutics shares tumble after its Phase II Amplifgy-7P trial of KRAS-targeting immunotherapy ELI-002 7P misses its primary endpoint in adjuvant pancreatic cancer, FDA approves Skinvive by Juvéderm as the first and only hyaluronic acid injectable indicated to reduce neck lines, and Pharmaceutical Executive speaks with Dr. Edward Littler and Dave Watson, the newly paired executive chairman and CEO of Persica Pharmaceuticals, on how they are driving the company's non-opioid pain program PP353 toward Phase III.

Elicio Therapeutics shares closed in a down position after the company reported that ELI-002 7P its amphiphile-based KRAS cancer immunotherapy failed to meet the pre-specified primary endpoint of disease-free survival in the intent-to-treat population of the Phase II Amplify-7P study in patients with resected stage I through III mutant KRAS-driven pancreatic ductal adenocarcinoma following standard locoregional therapy. The company attributed part of the imbalance to a higher proportion of R1 resection patients, those with positive surgical margins and a known worse prognosis, in the treatment arm versus the observation arm, and pointed to post-hoc analyses in R0 patients showing a 35 percent reduction in the risk of disease recurrence or death and a median disease-free survival of 23.8 months versus 12.8 months in the observation arm as the basis for a refined Phase III strategy focused on that population.

FDA has approved Skinvive by Juvéderm ,Allergan Aesthetics' hyaluronic acid microdroplet injectable, an AbbVie product, for a second indication covering the reduction of neck lines and improvement of neck appearance in adults over the age of 21, making it the first and only hyaluronic acid injectable cleared to treat horizontal neck lines. The approval is supported by a multicenter, evaluator-blinded, randomized controlled study in which 80 percent of patients treated with Skinvive achieved at least a one-grade improvement in neck lines by month one as assessed by investigators, and nearly 90 percent reported improvement in overall neck appearance on the Global Aesthetic Improvement Scale.

Finally, Pharmaceutical Executive speaks with Dr. Edward Littler, executive chairman, and Dave Watson, CEO of Persica Pharmaceuticals, both of whom joined the company around the same time and have built a rapid working alignment around a shared priority: advancing PP353, Persica's first-in-class non-opioid therapeutic candidate for vertebrogenic lumbar back pain associated with Modic changes, toward registrational trials. Watson explains that the unmet need goes beyond replacing opioids, patients with chronic low back pain require durable, evidence-based therapies that address the underlying drivers of pain and restore function rather than simply managing symptoms and that PP353, which targets the cause rather than the symptoms of vertebrogenic pain, showed in its Phase 1b trial a significant reduction in pain, improved daily functioning, and reduced painkiller use including opioids.

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