Auris Medical says Altamira met with FDA for pre-submission meeting for Bentrio » 09:0905/0705/07/21
Auris Medical Holding and…
Auris Medical Holding and its affiliate Altamira Medica announced additional details on the outcomes from the clinical investigation of its Bentrio nasal spray in allergic rhinitis and provided an update on the regulatory pathway in the US for the intended use in allergy. Bentrio was tested in an open-label randomized cross-over trial in 36 patients with allergic rhinitis to grass pollen. Study participants were administered a single dose of Bentrio nasal spray or a comparator product prior to controlled pollen exposure for four hours in an allergen challenge chamber. The challenge was repeated with the alternate treatment following a wash-out period. The study demonstrated a rapid onset and long durability of Bentrio's protective effect, established substantial equivalence to the marketed comparator with superior efficacy ratings by patients and clinicians, and showed good tolerability. Under treatment with BentrioTM, participants reported a mean increase in the Total Nasal Symptom Score of 4.75 points, which was 1.11 points and thus significantly below TNSS levels when exposed to pollen without nasal spray protection. A 1-point reduction in the TNSS is considered clinically relevant. 31.4% of study participants rated the efficacy of BentrioTM as "good" or "very good", while study investigators provided such rating for 45.7% of participants. Under treatment with the comparator product, a powder spray based on hydroxypropylmethylcellulose, the TNSS increased on average by 5.14 points, which was 0.71 points lower than when unprotected. 14.3% of study participants rated the efficacy of the comparator as "good" or "very good", while study investigators provided such rating for 25.0% of participants. Bentrio showed significantly lower increases in the TNSS than HPMC especially during the early phase of pollen exposure, reaching clinical relevance and suggesting a rapid onset of action. As previously announced, Bentrio met the primary endpoint of substantial equivalence in the change of TNSS relative to HPMC, which serves as a predicate device for the planned 510(k) submission to the US Food and Drug Administration. Final analyses show a difference of 0.4 points in favor of Bentrio, confirming non-inferiority. Proof of substantial equivalence to the predicate device is a key requirement for market clearance in the US under the 510(k) regulatory pathway. In addition, the study provided further evidence for the favorable safety profile of Bentrio; with the exception of one case, all study participants rated the tolerability favorably. On May 6, 2021, Altamira Medica met with the FDA for a pre-submission meeting relating to a 510(k) pre-market notification application. The Company expects to request regulatory clearance for Bentrio for the intended use in allergy under the 510(k) pathway. During the meeting, the Company obtained important information needed to help finalize the submission package. Importantly, the Agency indicated that the design of the pollen challenge study appeared appropriate to support the planned 510(k) submission.
|Over a week ago|
Largest borrow rate increases among liquid names » 08:4504/2004/20/21
INO, ATNF, IPOE, EARS, HIMS, MVIS, QS, SENS, MOGO, SEAC
Latest data shows the…
Latest data shows the largest indicative borrow rate increases among liquid option names include: Inovio (INO) 4.18% +2.75, 180 Life Sciences (ATNF) 97.04% +2.66, Social Capital Hedosophia V (IPOE) 40.75% +2.29, Auris Medical (EARS) 71.08% +1.61, Hims and Hers Health (HIMS) 7.81% +1.03, Microvision (MVIS) 11.38% +1.03, Quantumscape (QS) 8.71% +0.66, Senseonics (SENS) 3.23% +0.64, Mogo (MOGO) 20.58% +0.58, and SeaChange (SEAC) 3.63% +0.53.
Largest borrow rate increases among liquid names » 08:4504/1904/19/21
BTBT, ACIC, FUSE, EARS, WWR, KALA, LAZR, OUST, SEAC, CBAT
Latest data shows the…
Latest data shows the largest indicative borrow rate increases among liquid option names include: Bit Digital (BTBT) 14.72% +2.16, Atlas Crest Investment Corp (ACIC) 3.06% +0.99, Fusion Acquisition Corp (FUSE) 1.25% +0.69, Auris Medical (EARS) 74.03% +0.46, Westwater Resources (WWR) 21.61% +0.43, Kala Pharmaceuticals (KALA) 29.29% +0.42, Luminar Technologies (LAZR) 5.72% +0.29, Ouster Inc (OUST) 14.17% +0.27, SeaChange (SEAC) 3.65% +0.25, and CBAK Energy Technology (CBAT) 35.48% +0.23.
Auris Medical announces clinical data testing AM-301 with COVID-19 » 07:5704/1304/13/21
Auris Medical announced…
Auris Medical announced Altamira Medica obtained first data from testing AM-301 after the start of infection of human nasal epithelium cells with SARS-CoV-2. In the new experiment, daily treatment with AM-301 started 24 or 30 hours post inoculation. Saline- and vehicle-treated and untreated cell cultures served as controls. In control cultures, SARS-CoV-2 replicated efficiently over four days, resulting in a rapid increase in viral titer. Daily treatment with AM-301 resulted in a statistically significant deceleration of the viral titer growth compared to controls. At Day 4 of the experiment, viral titers were 73.7 to 94.5% lower compared to controls. Altamira Medica intends to launch the commercialization of AM-301 under the brand name BentrioTM in selected European countries starting in June 2021, employing various on- and offline distribution channels. The company expects to expand market coverage rapidly during the second half of 2021, including collaborations with future licensing partners. The expansion will be supported by significant, scalable contract manufacturing capacity.
Auris Medical provides clinical evaluation of AM-301 nasal spray » 07:5704/1304/13/21
Auris Medical provided an…
Auris Medical provided an update on its AM-301 program for protection against airborne viruses and allergens. Altamira Medica recently completed the treatment phase of its open-label randomized cross-over clinical investigation of AM-301 in 36 patients with allergic rhinitis to grass pollen. Study participants were administered a single dose of AM-301 nasal spray or a comparator product prior to controlled pollen exposure for four hours in an allergen challenge chamber. The challenge was repeated with the alternate treatment following a wash-out period. Preliminary analyses show that AM-301 met the primary endpoint of non-inferiority in the Total Nasal Symptom Score, or TNSS, relative to the marketed comparator product, which serves as the predicate device for the planned 510k submission to the Food and Drug Administration. In addition, the treatment was well tolerated. Proof of substantial equivalence to the predicate device is a key requirement for market clearance under the 510k regulatory pathway. Furthermore, the allergen challenge study demonstrated a rapid onset and long durability of AM-301's protective effect, as measured by a clinically relevant 1-point reduction in the TNSS compared to unprotected pollen exposure. On average, the protective effect was maintained for at least three hours. These clinical observations are in line with the results from a new in vitro study based on a barrier diffusion model. The assay, which was performed at 35 degrees C and 90% relative humidity to mimic conditions within the nasal cavity, showed that a thin layer of AM-301 prevented Timothy grass pollen from diffusing into an agar block for up to 6 hours, the maximum duration of the experiment.
Auris Medical to host business news update conference call » 07:2504/1304/13/21
Management provides a…
Auris Medical to host business news update conference call » 04:5504/1304/13/21
Management provides a…
Auris Medical to host business news update conference call » 16:0604/0904/09/21
Management provides a…
|Over a month ago|
Auris Medical sees 2021 total cash needs CHF11.5M-CHF13M » 08:4603/3103/31/21
The Company expects its…
The Company expects its total cash needs in 2021 to be in the range of CHF 11.5 to 13 million for expected total operating expenses of CHF 7 to 7.5 million and expected capitalized research and development costs of CHF 4.5 to 5.5 million. Further cash needs may arise in 2021 related to the manufacture of AM-301 as well as marketing and sale activities as the Company intends to commercialize the product in selected markets; these cash needs may initially not be covered by cash flows from product revenues.The Company expects its total cash needs in 2021 to be in the range of CHF 11.5 to 13 million for expected total operating expenses of CHF 7 to 7.5 million and expected capitalized research and development costs of CHF 4.5 to 5.5 million. Further cash needs may arise in 2021 related to the manufacture of AM-301 as well as marketing and sale activities as the Company intends to commercialize the product in selected markets; these cash needs may initially not be covered by cash flows from product revenues.
Auris Medical reports 2020 EPS (CHF1.36) vs. (CHF2.28) last year » 08:4503/3103/31/21
"The 2020 business…
"The 2020 business year has been quite transformative for our company as we initiated the development of AM-301, a nasal spray designated for self-protection against airborne viruses and allergens," stated Thomas Meyer, Auris Medical's founder, Chairman and CEO. "With a highly dedicated team, we managed to develop in less than six months a drug-free nasal spray that reduced the SARS-CoV-2 viral titer in a model representative of the human nasal mucosa by more than 99%. The project has taken on strong momentum, and we look forward to making AM-301 available to consumers, starting towards the end of the second quarter 2021 in selected markets. With this, we expect to become a commercial stage company quite shortly." He continued: "The project benefited greatly from our experience acquired with AM-125, our nasal spray for the treatment of acute vertigo. Here, we obtained last year promising interim data in our Phase 2 trial and expect the trial to read out in 2021. Last, but not least, we entered the new business year with a significantly stronger balance sheet, and strengthened our cash position further in the first quarter of 2021."