Q BioMed touts development progress of coronavirus treatment MAN-19 and other therapies in letter to shareholders

Q BioMed Inc (OTCQB:QBIO) has released a letter to shareholders, bringing them up to speed on the developments of its technology partner, Mannin Research, and its work to treat the coronavirus (COVID-19).

The company announced in March that Mannin would receive up to C$1.7 million worth of R&D funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support the preclinical development of a therapeutic, MAN-19, to treat Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients. This funding adds to roughly US$7 million granted in Europe, which together will represent 65%-75% of the funds to advance the ARDS therapy and others.

As COVID-19 cases rise around the world even as vaccines are being rolled out in the US and elsewhere, Q BioMed says Mannin is accelerating MAN-19’s development. Additionally, MAN-19 is virus-agnostic, which makes it relevant to other viral diseases like influenza and even possible future viral pandemics. That could make it a potential government stockpile drug.

READ: Q BioMed announces five year contract with the US Department of Defense and Veterans Affairs for its cancer bone pain drug

Furthermore, a successful proof-of-concept clinical trial with MAN-19 in COVID-19 patients would provide the clinical dataset to support the development of therapeutics for other vascular diseases such as sepsis, acute kidney injury and glaucoma. 

Meanwhile, Q BioMed said it continues to back Mannin’s effort to develop glaucoma therapies.

“We continue to support the development of Mannin’s MAN-01 and MAN-11 therapeutics, a novel small-molecule, and novel biologic therapeutic for glaucoma, respectively,” the company said in the letter to sharteholders.

“There are over 60 million patients worldwide with primary open-angle glaucoma. The MAN-01 program is developing topical drops designed to reduce pressure build-up in the eye by assisting with, and correcting drainage problems in tiny vessels in the eye. We have advanced this asset from ‘concept to compound’, and the preliminary data that we have reviewed has convinced us to continue pursuing these product candidates.”

Going forward, the next steps are to initiate toxicology studies for both therapies in 2021, with the goal of initiating a Phase 1 proof-of-concept trial in late 2021. In 2019, the company licensed a diagnostic biomarker for determining the severity of glaucoma, GDF-15, which it calls “a perfect companion diagnostic for the MAN-01 and MAN-11 drugs.”

In partnership with Mannin and McMaster University, Q BioMed says it is nearing completion of an in-vitro-diagnostic (IVD) with both point-of-care and external laboratory-based detection. With appropriate funding, the company anticipates completion of the IVD by the end of June with submission to the US Food & drug Administration (FDA) for approval in late 2021 or early 2022.

Strontium-89

Meanwhile, Q BioMed told investors it expects revenues from its bone pain treatment, Strontium-89, to ramp up this year. The company is assessing several potential clinical trial programs that may expand the indication beyond pain relief into a therapeutic use that may increase utilization in years to come.

In March, Q BioMed was approved as a federal supplier which will allow it to sell into federal hospital systems, notably the US Department of Veteran Affairs and Department of Defense. The company is preparing to launch a contract sales force to increase its presence and uptake in both government and non-government facilities this year.

Elsewhere, EU approval for the drug is expected by the second half of this year, the company said. It is also midway through the registration process in a bevy of other countries around the globe with approvals expected in the next few months and beyond.

Uttroside-B

Q Biomed is also developing a treatment for liver cancer, a disease indication for which there are only two approved first-line therapies, the company said. 

Uttroside-B was discovered in the leaf of the black nightshade plant in India, and the company successfully synthesized an exact replica. Preparations are underway to advance this into a preclinical program, and it was recently awarded Orphan Drug designation by the FDA. Testing is expected to begin in late May 2021.

Autism

“While our immediate focus is on the above-mentioned assets, we are also developing a new drug candidate to treat young children with pediatric minimally verbal autism,” Q Biomed CEO Denis Corin noted. “The advancement of this program will depend on the availability of funds and resources as we prioritize our clinical development milestones. There is no effective treatment available to help an estimated 250,000 children born with the condition worldwide each year, 20,000 of them in the United States. We are working on a discovery and development program to address this highly unmet need.”

Q BioMed has raised US$1.1 million since December 1 and additional non-dilutive grant funding of approximately $1.5M has helped its development progress, the CEO said. 

“Our mission is to solve problems by accelerating the development of important therapies and availability of those therapies to patients,” he added. “We believe that our expected funding in conjunction with an uplist to a national securities exchange will result in an enhanced valuation as a larger group of investors and institutions can participate in our equity.”

Contact Andrew Kessel at [email protected]

Follow him on Twitter @andrew_kessel

Story by ProactiveInvestors