This week's Philadelphia-area life sciences industry update has news on a couple of Food and Drug Administration marketing clearances, an application seeking approval for a new medical device, a potential hepatitis B treatment, and more.
Here's the roundup:
Incyte
The Wilmington biotechnology company has received FDA approval for Opzelura, a topical treatment for the skin disorder vitiligo.
The approval for Incyte (NASDAQ: INCY) covers the use of Opzelura cream to treat nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Vitiligo is a chronic autoimmune disease characterized by skin depigmentation, or loss of color. The condition afflicts more than 1.5 million people In the United States.
“With the approval of Opzelura, Incyte has delivered a treatment to patients with high unmet medical need who previously had no approved therapies,” said Hervé Hoppenot, the company's CEO.
In September 2021, Opzelura was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis.
Neuronetics
The Malvern medical technology company received clearance from the FDA for its NeuroStar transcranial magnetic stimulation system to be used to treat anxiety symptoms for adult patients who suffer from major depressive disorder — a condition also known as anxious depression.
Keith J. Sullivan, CEO of Neuronetics (NASDAQ: STIM), called the new indication clearance a "big win" for NeuroStar patients and providers.
“Many people suffering from major depressive disorder also experience anxiety symptoms, and these patients with anxious depression are more likely to be severely depressed and to have more thoughts of suicide," Sullivan said.
The system, which delivers transcranial magnetic stimulation (TMS) to the brain, uses highly focused MRI-strength magnetic field pulses to activate cortical and deep brain structures known to be involved in mood regulation. The TMS treatment can be delivered in a physician's office in under 19 minutes.
The NeuroStar system has already been used to treat more than 134,000 patients diagnosed with major depressive disorder. In May, the system received FDA clearance as an adjunct therapy for treating adult patients suffering from obsessive-compulsive disorder.
Waypoint Orthopedics
The privately held spinal instrumentation company has submitted a 510k application with the FDA seeking marketing clearance for its Waypoint GPS.
The Waypoint GPS a smart bone awl for use during pedicle screw pilot hole drilling. The system is designed to provide spine surgeons with visual feedback, in the form of a change in color at the tip of the probe, to indicate possible contact of the tip with soft tissues and possible vertebral cortex perforation.
The company is seeking approval to use its Waypoint GPS in both open and percutaneous (through a needle puncture in the skin) surgical approaches.
Jeffrey F. O'Donnell Jr., CEO of Malvern-based Waypoint Orthopedics, said the company's product developers — working with the company's surgical advisory board — spent the past 18 months developing what he described as a "much-needed tool" for the operating room, while potentially reducing the amount of ionizing radiation used during a spine case.
Waypoint Orthopedics, a Runway Healthcare LP portfolio company, plans to transfer its technology to a commercial medical device company if and when it secures approval for the system from the FDA.
Arbutus Biopharma Corp.
The Warminster biopharmaceutical company announced that while its partner, Assembly Biosciences, has decided to discontinue development of its investigational hepatitis B virus treatment candidate vebicorvir, also known as VBR, Arbutus plans to continue studying a combination therapy that includes VBR.
Arbutus (NASDAQ: ABUS) said it will, in consultation with South San Francisco-based Assembly Biosciences (NASDAQ: ASMB), continue dosing patients in its Phase 2 triple-combination clinical trial evaluating Arbutus' proprietary RNAi therapeutic, AB-729, with VBR and a nucleoside analogue as a potential therapy for the treatment of patients with chronic HBV infection.
Preliminary data from the trial are expected in the second half of 2022.
“While we respect Assembly’s decision to discontinue clinical development of VBR, we believe that it is premature to make any conclusions about any results in this triple combination clinical trial," said William Collier, CEO of Arbutus. "We intend, in collaboration with Assembly, to continue the clinical trial in order to fully and accurately assess the results."
Quick Hits
Nabriva Therapeutics (NASDAQ: NRBV) of Fort Washington entered into an exclusive distribution agreement for Xenleta, its drug for community-acquired bacterial pneumonia, with Er-Kim. Financial terms of the agreement are being kept confidential. Under the terms of the deal, Er-Kim of İstanbul gets exclusive rights to distribute Xenleta in Bulgaria, Croatia, the Czech Republic, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia. Er-Kim also may distribute the prescription antibiotic in an additional five undisclosed countries through a named patient usage program. Nabriva will be the exclusive supplier of Xenleta to Er-Kim. The FDA granted marketing approval to Nabriva for Xenleta in 2019. … Devon-based Zynerba Pharmaceuticals (NASDAQ: ZYNE) entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital Fund, a Chicago-based institutional investor. Under the terms of the agreement, the company will be able to sell to Lincoln Park Capital up to $20 million worth of shares of its common stock, at market price, over the 36-month term of the deal. The proceeds from any stock sale will be used by Zynerba to further support its clinical development efforts for Zygel, the company's lead new drug candidate targeting Fragile X syndrome and 22q11.2 deletion syndrome. … Neuraptive Therapeutics, a Philadelphia biotech company, enrolled the first patient in its Phase 2 clinical trial evaluating the safety and efficacy of its new drug candidate NTX-001 as a potential treatment of, and prevention for, facial paralysis.
