Shares of Q BioMed Inc.(OTCMKTS: QBIO) rose sharply on heavy volume after the company announced that a new collaboration among researchers at McMaster University, Mannin Research and the emerging biotechnology accelerator, focuses on ophthalmic drug delivery and formulation experiments for MAN-01, a first in class small molecule to treat Primary Open-Angle Glaucoma. Experiments will be conducted Dr. Heather Sheardown, a world renowned thought leader in ophthalmic biomaterials and drug delivery.
With 70 million patients in the world, and with expectations that this will grow to 100 million in the coming years, more effective and more easily delivered glaucoma treatments are needed by ophthalmologists and patients. Currently, a limited variety of options are available to treat glaucoma including intravitreal needle injections to the eye, expensive drops with side effects, laser procedures, and surgery. All are intended to decrease eye pressure and, thereby, protect the optic nerve but demand for new options has increased.
The main objective of the collaboration is to explore novel and better ways of delivering Mannin’s small molecules to the eye to treat glaucoma. Using the formulation and drug delivery expertise of the Sheardown laboratory, the collaboration partners are focusing on increasing the compound’s ability to lower intra-ocular pressure to more effectively treat glaucoma.
The primary treatments for open angle glaucoma have been around for 20 or more years now, primary treatments like latanoprost and prostaglandins. There are other drugs and procedures that are invasive, having an injection or laser surgery or a stent put in the eye. The thought of having a needle stuck in the eye deters a great many patients. Researchers, therefore, have set to work on developing a treatment that allows patients to simply treat themselves with an eye drop every day.
Last summer, Aerie Pharmaceuticals announced the launch of Rhopressa (netarsudil ophthalmic solution), a novel eye drop indicated for lowering elevated intraocular pressure in patients with glaucoma and ocular hypertension. Rhopressa is a rho kinase inhibitor that was approved by the Food and Drug Administration (FDA) in December 2017. The approval was based on results from 3 randomized trials which found that Rhopressa was associated with a reduction in intraocular pressure. Last fall, the FDA also approved Sun Pharmaceutical’s Xelprostm.
Q Biomed’s MAN-01 is different in that it works to correct the flow in the Schlemm’s Canal, the main drainage vessel in the eye, responsible for draining 70-90% of the fluid in the eye. MAN-01 helps with the realignment of the cellular structure in that vessel that allows for the effect of drainage or fluid from the front to the back of the eye and out preventing interocular eye pressure building up. When the canal does not drain effectively, the eye starts to swell under that pressure and pushes on the optic nerve at the back of the eye, causing glaucoma and ultimate blindness. A topical eye drop delivery for MAN-01 is important for patient compliance to ensure that they are actually using it, without discomfort, on a daily basis.
CEO of Mannin Research, Dr. George Nikopoulos stated, “This collaboration is extremely important for us and Q BioMed, as well as the MAN-01 program. The Sheardown lab at McMaster University specializes in ophthalmic delivery systems. As we approach our Phase I clinical trial, having the renowned expertise and experience of Dr. Sheardown and her team working with us on delivering our small molecule candidates to the eye is important to our success.”
Q BioMed’s CEO Denis Corin commented, “Through this collaboration, we are also exploring the use of extended and sustained release formulations with the Mannin compounds for the treatment of other vascular related diseases, such as acute kidney injury, influenza, and myocardial ischemia. We expect the ophthalmic drug delivery data from this collaboration will inform our planned Investigational New Drug (IND) application with the U.S. FDA.”
The company expects to complete the formulation and do some of the pre-clinical and toxicology testing necessary to file that IND. “Our target is to do that before the end of the year and to release data along the way,” added Corin. “As we finalize and pick a specific molecule, those clinical developmental milestones will become more important and we can certainly make those public and announce them as we move forward- like picking the ultimate molecule, starting the toxicology testing, submitting the IND to the FDA and then getting approval to start the clinical trials.”
Aerie Pharmaceuticals has a market cap of $2.08B while Sun Pharma is valued at $ 1.01T, so Corin is hopeful that investors in his small-cap firm, whose shares have been rising steadily since the beginning of 2019, will see the benefit of his team’s diligent work. “As an innovator and an accelerator, we’re always looking for innovative drugs and developmental opportunities that we think we can bring value to by providing those assets with either technical knowledge or know how or capital or just the management experience, et cetera,” said Corin. “We’re not too far off getting into the clinic in what obviously would be a multi-billion dollar opportunity.”