Phase 3 Trials for a potential new treatment are set to begin enrollment in the second quarter of 2023, pending discussions with the FDA. Exciting progress is being made in the search for a new solution, and researchers are hopeful that the trial will open up new possibilities.
Apnimed, Inc., a clinical-stage pharmaceutical company striving to revolutionize the treatment of obstructive sleep apnea (OSA) and related disorders, has secured $79.75 million in an oversubscribed financing round, bringing its total Series C financing to an impressive $142.25 million. The round was led by Alpha Wave Ventures and included existing investors Sectoral Asset Management, Columbia-Seligman Investments and Tao Capital Partners. This additional funding will enable Apnimed to continue developing its groundbreaking oral pharmacologic therapies and make sleep apnea a thing of the past.
Apnimed has secured financing to fund their Phase 3 clinical trials for their lead candidate, AD109, which has the potential to be the first oral treatment for Obstructive Sleep Apnea (OSA). If all goes according to plan, enrollment for the trials is expected to begin in the second quarter of 2023, following discussions with the U.S. Food and Drug Administration (FDA). This would be a groundbreaking advancement in the treatment of OSA, offering a much-needed alternative to current treatment options.
Apnimed has just received a substantial additional investment, a resounding vote of confidence from its investors. With this funding, the company can progress towards late-stage clinical trials that will form the basis for approval of its OSA treatment, AD109. This new pharmaceutical treatment option is highly anticipated, as there is a great need for better solutions to this serious disorder. AD109 could potentially revolutionize OSA treatment, changing the paradigm for those afflicted.
Apnimed is on the brink of revolutionizing the way obstructive sleep apnea is treated. The Phase 2 MARIPOSA study of its new oral treatment yielded highly promising results and informed the design of the two Phase 3 trials. Leading this effort is Alpha Wave Ventures, which is thrilled to be spearheading the financing for the registration Phase 3 trials so more patients can benefit from this alternative therapy.
About AD109
AD109 is a revolutionary oral pharmacologic that could revolutionize the treatment of Obstructive Sleep Apnea (OSA). It is the first of its kind to both treat the root cause of OSA, airway obstruction at night, and improve the associated daytime consequences such as fatigue. The novel combination of selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine) is designed to treat OSA patients across a broad spectrum of disease severity. AD109 works by targeting key neurological pathways in OSA to maintain an open airway during sleep. It could provide a safe, effective, and convenient alternative to current treatments, such as CPAP or surgery, which can be poorly tolerated or invasive. AD109 could be a game-changer for those suffering from OSA.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AD109, a potential treatment for a serious condition. This means that the FDA will provide an accelerated review process for the drug, with the goal of getting it to those who need it as quickly as possible.
About Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA) is a serious sleep disorder that affects millions of Americans, though it is drastically underdiagnosed. OSA is characterized by partial or complete upper airway obstruction that occurs during sleep, leading to poor sleep quality, and long-term impacts such as hypertension, diabetes, cardiovascular disease, and stroke. It can also impair work performance, reduce daytime functioning, and lower quality of life. The central nervous system is the key mechanism driving sleep-related muscular relaxation, which is the cause of OSA. Unfortunately, the most common form of therapy, positive air pressure devices such as continuous positive airway pressure (CPAP), is often ineffective and poorly tolerated by patients. This leaves a significant population untreated, putting them at risk for serious health complications.
About Apnimed
Apnimed is a revolutionary clinical-stage pharmaceutical company that is striving to revolutionize the way that sleep apnea is treated. The company’s unique approach is based on the concept that those suffering from obstructive sleep apnea may be able to benefit from a once-daily oral medication taken at bedtime. Apnimed is currently based in Cambridge, Mass. and is developing a range of cutting-edge pharmacological treatments for sleep apnea and other related disorders, with the aim of providing a more effective and safe way of treating the condition.