Formosa Pharmaceuticals News
APP13007 completes Phase 2 clinical trial and EOP2 meeting.
Formosa Pharmaceuticals and AimMax Therapeutics report top-line results from a Phase 2 clinical trial of APP13007 for the treatment of inflammation and pain after cataract surgery. The End-of-Phase 2 meeting with the FDA is successful, setting the stage for pivotal Phase 3 trials to begin as early as 2020-Q4.
- APP13007 meets primary endpoints demonstrating rapid clearance of anterior chamber cells (ACC) and rapid resolution of ocular pain with a twice-daily dosing regimen following cataract surgery. In addition, APP13007 is well tolerated with no treatment-related adverse events.
- Results validate Formosa Pharmaceuticals’ proprietary APNT nanoparticle formulation platform for enhancing dissolution of water-insoluble APIs to enable novel formulations for ocular delivery.
TAIPEI, Taiwan, September 14, 2020 – Formosa Pharmaceuticals, Inc. (Taiwan) and AimMax Therapeutics, Inc. (United States) announce successful Phase 2 clinical trial outcomes for APP13007, a novel, twice-daily, topical corticosteroid nanosuspension for the treatment of inflammation and pain after cataract surgery. APP13007 was assessed in a randomized, double-masked, placebo-controlled trial evaluating 132 patients across 9 study sites in the United States. APP13007 was dosed twice a day (BID) or via a tapered schedule for 14 or 21 days. APP13007 BID showed statistically significant improvement over placebo vehicle in the two primary endpoints to be used in the forthcoming Phase 3 studies:
Anterior Chamber Cell Clearance (ACC = 0): There was rapid clearance of the ACC: 32% of patients had an ACC=0 from POD8 sustained to POD15 in the active arm as compared to 4% in the placebo vehicle arm.
Ocular Pain Grade (Grade = 0; pain free): There was rapid resolution of pain: 73% of patients were pain free from as early as POD4 sustained to POD15 in the active arm as compared to 48% in the placebo vehicle arm.
In addition, there was rapid resolution of anterior chamber flare and improvement of visual acuity. No study drug related adverse events and no study drug related changes in intraocular pressure were reported.
“We are pleased to see the very positive efficacy and safety results of APP13007 in this Phase 2 trial, demonstrating potency and tolerability of the active corticosteroid in the formulation” said AimMax Therapeutics’ Chief Medical Officer, Dr. Derek Nunez, M.D. “It is extremely encouraging to have a very successful EOP2 meeting with the FDA to reach agreement with the design of the Phase 3 clinical trials and the overall development plan leading to NDA submission. We look forward to successful completion of the Phase 3 trials and bringing this novel product to the marketplace”, said AimMax Therapeutics’ Chief Executive Officer, Dr. Laurene Wang, Ph.D.
“We are delighted to see APP13007 take a significant step closer to providing a novel, effective, convenient, and comfortable therapy for patients having cataract surgery. Additionally, this outcome validates Formosa Pharma’s proprietary APNT formulation platform, from which APP13007 is derived, to enhance the dissolution of water-insoluble APIs which enable aqueous formulations or other dosage forms that could potentially enhance penetration and bioavailability,” said Formosa Pharmaceuticals’ Chief Executive Officer, Dr. Erick W. Co, Ph.D.
About Formosa Pharmaceuticals:
Formosa Pharmaceuticals is a late-preclinical to early-clinical biotech company focused primarily in the areas of ophthalmology and oncology. The company’s proprietary nanoparticle formulation platform (APNT) improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration routes.
Formosa Pharmaceutical’s advanced programs are:
- APP13007: 505(b)(2) steroid formulation for the topical treatment of inflammation and pain after ocular surgery. Phase 2 completed; Phase 3 to start in 2020-Q4.
- TSY-0110: ado-trastuzumab emtansine biosimilar (Kadcyla®); Phase 1 clinical trials to start in 2021-Q4 to 2022-Q1.
- APP13002: 505(b)(2) antibiotic formulation for infectious eye diseases. Preclinical.
For more information and details about Formosa Pharmaceuticals’ operations and other pipeline candidates, please visit www.formosapharma.com.
About AimMax Therapeutics, Inc.:
AimMax Therapeutics, Inc., located in Research Triangle Park, North Carolina, United States, engages in the research and development of biopharmaceuticals at various stages through in-licensing or co-development with strategic partners, primarily in the anti-inflammatory and anti-infective therapeutic areas. The company’s core strengths derive from R&D professionals with diverse and synergistic backgrounds in the areas of translational medicine, nonclinical research, clinical trial design, regulatory and commercial strategy.
For more information about AimMax Therapeutics, please visit www.aimmaxrx.com.
Formosa Pharmaceuticals, Inc.
Dr. Erick W. Co, Ph.D., CEO
AimMax Therapeutics, Inc.
Dr. Laurene Wang, Ph.D., Founder and CEO