This week's Lab Notes includes items on the formation of a new company and updates on an experimental drug to treat a side effect of radiation therapy and a medical device being developed to help patients with blood pressure.
Here's the roundup:
Virpax
The Berwyn life sciences company that specializes in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system disorders has formed a new wholly-owned subsidiary called Novvae Pharmaceuticals Inc.
Virpax CEO Anthony P. Mack said Novvae was established to focus exclusively on advancing Virpax’s pipeline over-the-counter products.
Those Virpax products include, Probudur, which is expected to enter mid-stage testing as a potential injectable treatment for post-operative pain next year, and Envelta, a potential treatment for acute and chronic pain including pain associated with cancer. Envelta is expected to enter phase 1 human clinical trials next year.
Novvae's pipeline will be led by AnQlar, a product being developed as a once-a-day antiviral nasal spray. In several preclinical studies, according to the company, AnQlar demonstrated 24-hour anti-viral barrier activity against both Influenza and Covid. Novvae will assume responsibility for future development on AnQlar, leading to its first in human trials.
Virpax disclosed it is in advanced discussions for global rights of first refusal on two differentiated non-prescription assets, and should the company acquire the undisclosed product candidates they would be added to the Novvae pipeline.
Galera Therapeutics
The Malvern biopharmaceutical company said it has scheduled a meeting with the Food and Drug Administration for Sept. 28 to discuss the federal agency's complete response letter to Galera's new drug application for avasopasem.
In August, the FDA rejected the application saying the company’s clinical trial was “not sufficiently persuasive” to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer. The FDA told the company results from an additional clinical trial will be required for resubmission.
At the time, Galera (NASDAQ: GRTX) CEO Dr. Mel Sorensen called the decision "deeply disappointing for Galera and for patients who suffer from severe oral mucositis" and vowed to continue the company's efforts to get the drug approved.
Oral mucositis is a side effect of radiation therapy that can result in patients developing painful ulcers in the tissues in their mouth and throat, making them unable to eat solid food or drink liquids. Patients with the condition may require the surgical placement of feeding tubes to maintain nutrition and hydration.
"We look forward to further understanding the FDA’s review of our [application] for avasopasem and the data from our two randomized placebo-controlled clinical trials,” Sorensen said earlier this week. “We believe in avasopasem’s potential to bring meaningful benefit to patients with head and neck cancer suffering from severe oral mucositis."
Sorensen said the company is hopeful the meeting with the FDA will "identify necessary steps" to bring avasopasem to patients.
Orchestra BioMed Holdings
The New Hope biomedical company received an investigational device exemption approval from the FDA to initiate a study evaluating the effectiveness and safety of its experimental BackBeat CNT therapy for treating hypertensive patients who are indicated for a dual-chamber cardiac pacemaker.
BackBeat CNT, also known as atrioventricular interval modulation (AVIM) therapy, is a bioelectronic treatment that the company says “immediately, substantially and chronically” lowers blood pressure while simultaneously modulating the patient’s autonomic nervous system. The therapy mimics the effects multi-drug hypertension therapy has on the volume of blood moving through the heart, the stiffness of the arteries carrying the blood and the constriction of blood vessels.
Medtronic (NYSE: MDT) is supporting the study under the terms of a collaboration and product development agreement it signed with Orchestra BioMed (NASDQ: OBIO) last summer.
“We believe this innovative therapy has the potential to substantially improve the standard of care for hypertensive pacemaker patients and we look forward to initiating the study before the end of 2023," David Hochman, founder and CEO of Orchestra BioMed, said in a statement.
If approved, Medtronic will have exclusive global rights to commercialize Orchestra BioMed's AVIM-enabled pacing systems for the target population. Orchestra BioMed will share in the revenues generated from Medtronic sales.
Quick Hits
Gurnet Point Capital and Novo Holdings completed their previously announced $462 million acquisition of Paratek Pharmaceuticals, a biopharmaceutical company with operations in King of Prussia and Boston.…Wayne-based Aclaris Therapeutics (NASDQ: ACRS) announced positive results from a phase 1 clinical of its new drug candidate ATI-2138, which is being developed initially as a potential treatment for ulcerative colitis. A phase 2 clinical trial is expected to begin in early 2024.
