With the acquisition of Vienna-based biotech Panoptes Pharma, Eye Gate Pharmaceuticals has expanded its pipeline of nonsteroidal products targeting ocular inflammation by adding Panoptes’ PP-001, Ocular Bandage Gel (OBG), a topical gel to assist in surgical corneal wound healing; and MoxiGel, a product indicated for bacterial conjunctivitis.
PP-001 has two clinical-stage ophthalmic formulations designed to treat ocular inflammatory disease without steroids: PaniJect, an intravitreal injection for treatment of the back of the eye, including posterior uveitis and diabetic retinopathy; and PaniDrop, an eye drop for ocular surface diseases, including viral conjunctivitis and dry eye disease.
Phase Ib/IIa safety and efficacy data for PaniJect have been encouraging. A preclinical study showed a 70% reduction in relapsing uveitis. In human peripheral blood lymphocyte (PBL) cultures, PP-001 suppressed relapsing experimental uveitis and cytokine/chemokine secretion of human lymphocytes without affecting retinal pigment epithelium (RPE) cells.
PaniDrop remains squarely in Phase I. Animal studies have shown it’s effective in treating dry eye disease and conjunctivitis. Panoptes says PaniDrop improves delivery of its active component — a specific nanomolar inhibitor — and improves tolerability compared with current treatments: no stinging or burning when using the drops.
One product in EyeGate’s pipeline, OBG, is based on a modified form of the natural polymer hyaluronic acid. It’s designed to protect the ocular surface to re-epithelialize the cornea and improve ocular surface integrity. Clinical evaluations are focusing on two different indications: photorefractive keratectomy (PRK) surgery to demonstrate corneal wound repair after refractive surgery, and dry eye to reduce punctate epitheliopathies.
Panoptes’ science uses dihydroorotate dehydrogenase (DHODH) inhibitors to subdue inflammation. DHODH is an enzyme in cell mitochondria. Inhibition of DHODH has shown some promise in the treatment of acute myeloid leukemia,1 and has proven effective for the treatment of malaria, autoimmune diseases, cancer, rheumatoid arthritis, and psoriasis.2
Panoptes’ progress in developing DHODH inhibitors for ocular indications made the company an attractive target for EyeGate, CEO Stephen From said in a statement.
“While DHODH inhibitors have been successfully developed for a range of autoimmune conditions, their utility has been limited due to tolerability and safety concerns,” From said. “We believe PP-001 has overcome these limitations. With promising clinical safety and efficacy data in hand, and ophthalmic formulations to target indications with a medical need on the ocular surface and the back of the eye, we are poised to begin a robust clinical program for PP-001.”
The markets Panoptes has targeted have significant upside. The global uveitis treatment market is expected to grow by a 5.5% compound annual growth rate (CAGR) and reach $686.1 million by 2025. PaniJect joins XIPERE, a product recently developed by Bausch Health and Clearside Biomedical for uveitis-associated macular edema, among other emerging treatments.
The dry eye disease market remains strong, with analyst Fortune Business Insights projecting a 6.9% CAGR and a $7.73 billion market by 2026.
Provided the products progress to Food and Drug Administration and other regulatory approvals, EyeGate seems to have negotiated a favorable deal. Under the acquisition agreement, Panoptes becomes a wholly owned subsidiary of EyeGate, which will invest about $4 million at close. An additional $1.5 million will be issued after 18 months, subject to adjustments for post-closing working capital or indemnification obligations.
The agreement also includes two cash or share earn-out provisions. Both call for additional payments of up to $4.75 million contingent upon patient enrollment in a Phase III pivotal study of any Panoptes product and FDA approval of a New Drug Application of a Panoptes product.
EyeGate’s share price got a boost as a result of the acquisition news, jumping from $3.57 on December 17, 2020 to $5.94 on December 23. It closed at $6.23 last week.
In addition to gaining Panoptes financial and clinical assets, EyeGate is adding Panoptes cofounders, CEO Franz Obermayr, PhD, and COO Stefan Sperl, PhD, to its management team.
“This acquisition by EyeGate, a clinical-stage public company with an ophthalmology focus, is testament to the Panoptes team’s success in developing our novel and highly innovative products,” Dr. Obermayr said in a statement. “I look forward to joining the EyeGate team to unlock the clinical potential of PP-001 across a diverse set of indications with high unmet medical need.”
- Sykes DB. The emergence of dihydroorotate dehydrogenase (DHODH) as a therapeutic target in acute myeloid leukemia. Expert Opin Ther Targets. 2018;22(11):893-898.
- Vyas VK, Ghate M. Recent developments in the medicinal chemistry and therapeutic potential of dihydroorotate dehydrogenase (DHODH) inhibitors. Mini Rev Med Chem. 2011 Oct;11(12):1039-1055.