Akouos Inc., of Boston, a precision genetic medicine company developing gene therapies to restore and preserve hearing, revealed its lead program, AK-OTOF, a gene therapy focused on restoring hearing in individuals with sensorineural hearing loss due to mutations in the otoferlin (OTOF) gene. Without functional otoferlin protein, auditory signals received by the ear cannot be transmitted to the brain. AK-OTOF uses an adeno-associated viral vector to deliver a healthy copy of the OTOF gene to cochlear hair cells, with the goal of restoring long-term physiologic hearing following a single administration to the inner ear.
Alimera Sciences Inc., of Atlanta, said it has expanded its relationship with Horus Pharma SAS, of Saint-Laurent du Var, France, one of its distributors of Iluvien in Europe, following the successful launch of the drug for diabetic macular edema (DME) in France. The companies have agreed to expand their relationship to introduce Iluvien for both DME and non-infectious posterior uveitis in the Benelux countries of Belgium, the Netherlands and Luxembourg.
Armata Pharmaceuticals Inc., of Marina Del Rey, Calif., disclosed its pipeline candidate, AP-PA02, a mixture of bacteriophages to treat serious respiratory infections of Pseudomonas aeruginosa, with an emphasis on cystic fibrosis patients. The drug has more robust killing kinetics than AP-PA01, which it will replace in Armata's pipeline, the company said. Armata plans to file an IND with the FDA in the fourth quarter, and the company also plans to file a clinical trial application in Europe.
Atomwise Inc., of San Francisco, and Hansoh Pharmaceutical Group Co. Ltd., of Jiangsu, China, are collaborating to develop drug candidates for up to 11 undisclosed targets in multiple therapeutic areas. Atomwise will use its artificial intelligence technology to develop the drugs, while Hansoh contributes its research and development, manufacturing and commercial capabilities. Atomwise is eligible for undisclosed technology access fees, option exercise fees, royalties and income based on sublicensing or sale of assets created under the collaboration that it believes could reach $1.5 billion.
Aytu Bioscience Inc., of Englewood, Colo., is acquiring Innovus Pharmaceuticals Inc., of San Diego, in an all-stock deal for up to $8 million in shares of Aytu common stock, less certain deductions, at the time of closing, which currently translates into approximately 4.2 million shares of Aytu stock. Innovus shareholders will also receive contingent value rights valued at up to $16 million to be paid in cash or stock over the next five years if certain revenue and profitability milestones are achieved. Through the deal, Aytu gains more than 30 consumer health care products that generated more than $24 million in revenue in the four quarters ending June 30, 2019.
Bioaxone Biosciences Inc., of Boston, said a publication in Translational Stroke Research describes data indicating that Rho kinase 2 inhibitor BA-1049 has promise as a therapeutic agent for treating cavernous angioma (CA), a rare disease with no currently available treatment options other than surgical removal of brain lesions. Findings showed potential for reducing CA disease progression for mild and aggressive forms of the disease, both by reducing non-heme deposition near lesions and by reducing lesion growth and maturation, while showing a promising safety profile after long-term (three to four months) of oral administration.
Cannabics Pharmaceuticals Inc., of Tel Aviv, Israel, presented data from tests on live cancer biopsies at the 2nd International Cannabinoid Derived Pharmaceuticals Summit in Boston. The company found synergistic effects where cannabinoid compounds enhanced the sensitivity of cells to chemotherapy drugs.
Catalia Health Inc., of San Francisco, and Pfizer Inc., of New York, have launched a 12-month pilot program using Catalia's Mabu Wellness Coach, a robot using artificial intelligence to gather insights into symptom management and medication adherence trends in patients outside the clinical setting. Initial data will be available in the coming months.
Imcyse SA, of Liège, Belgium, reported preclinical data for MS Imotope, its modified peptide designed to generate cytolytic CD4 T cells, at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Stockholm. MS Imotope produced inhibition of disease development and a statistically significant histological improvement in an autoimmune encephalomyelitis model.
Nanoviricides Inc., of Shelton, Conn., plans to initiate a 1-for-20 reverse split of its capital stock, which will be effective after the market closes on Sept. 23, in order to maintain its NYSE American listing.
Novelion Therapeutics Inc., of Vancouver, British Columbia, said the U.S. Bankruptcy Court for the Southern District of New York entered an order confirming the modified First Amended Joint Chapter 11 Plan for its subsidiaries, Aegerion Pharmaceuticals Inc. and Aegerion Pharmaceuticals Holdings Inc. The plan calls for Amryt Pharma plc, of Dublin, to acquire the reorganized Aegerion Pharmaceuticals. Pending approval of Amryt's shareholders, the deal will close on or about Sept. 24. Novelion also noted that it received a 15-day stay of the delisting of its common stock from Nasdaq, pending a hearing scheduled for Oct. 3. Novelion plans to hold a shareholder meeting on Nov. 5 to ask for shareholder approval of a proposed liquidation plan.
Ortho Regenerative Technologies Inc., of Montreal, selected MCRA LLC as the clinical research organization to run its phase I/II study of Ortho-R to treat rotator cuff injuries. The study will test Ortho-R, which consists of a mucoadhesive Chitosan-based biopolymer matrix mixed with patient conditioned plasma of a concentrate of proteins/growth factors, in 75 patients across three arms.
Regulus Therapeutics Inc., of La Jolla, published preclinical data on anti-miR-17 oligonucleotide RGLS-4326 in Nature Communications. RGLS-4326 attenuated cyst growth in human in vitro models of autosomal dominant polycystic kidney disease and multiple polycystic kidney disease mouse models after subcutaneous administration.
Vertex Pharmaceuticals Inc., of Boston, signed a five-year access agreement with the Scottish government to cover its cystic fibrosis drugs Orkambi (lumacaftor/ivacaftor) and Symkevi (tezacaftor/ivacaftor). Vertex agreed to collect real-world data on the medicines that will support any future submissions to the Scottish Medicines Consortium.