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OVID Plunges, VNDA's Hetlioz Scores Another FDA Nod, Auris Investors Smile Ear To Ear

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Today's Daily Dose brings you news about OVID'S Angelman syndrome trial failure, the FDA expanding approval of Vanda's Hetlioz to Smith-Magenis Syndrome, the 455% jump in stock price of Auris Medical, Histogen's phase Ib/IIa clinical trial results of HST-001 in male patients with androgenic alopecia, the outcome of Minerva's Type C Meeting with FDA related to Roluperidone and Regeneron's plans to test delivery of Covid-19 antibody cocktail via a gene therapy platform.

Read on…

1. What's making Auris Medical investors smile ear to ear?

Shares of Auris Medical Holding Ltd. (EARS) soared as much as 455% to touch a 52-week intraday high of $6.60 on Tuesday, following positive in vitro efficacy data for AM-301 in protecting against Sars-CoV-2 infection.

AM-301 is a drug-free nasal spray being developed by the company's affiliate Altamira Medica for protection against airborne pathogens and allergens.

According to the company, AM-301 forms a protective gel layer on the nasal mucosa when applied. This thin film is designed to prevent the contact of viruses or other pathogens and allergens with cells; in addition, the composition serves to "trap" such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory infections and promote alleviation of allergic symptoms.

In 'in vitro' test (lab test), there was 99.4% reduction of viral titer in human epithelial cell culture, suggesting the potential for AM-301 nasal spray to mitigate risk of Sars-CoV-2 infection.

The company noted that AM-301 will be put through additional tests before advancing the program towards the submission of regulatory applications in 2021.

EARS closed Tuesday's trading at $5.23, up 371.17%. In after-hours, the stock was down 26.77% at $3.83.

2. Histogen Down but Not Out

Shares of Histogen Inc. (HSTO) slumped over 17% on Tuesday as its phase Ib/IIa clinical trial of HST-001 in male patients with androgenic alopecia did not achieve statistical significance at the week 18 primary endpoint assessment.

Male androgenetic alopecia, also known as male-pattern baldness, is the most common form of hair loss affecting 30-50% of men by age 50. The patients first experience hair loss around the temples and over time, the hairline recedes and develops into "M "shape.

The primary study endpoint of the study was absolute change from baseline versus week 18 in total hairs (terminal and vellus) in the target area (TAHC) in the vertex as measured by Canfield's Hairmetrix macrophotography system. Secondary endpoints include absolute change from baseline in total hairs (terminal and vellus), new terminal and vellus hair count, hair thickness density as well as percent change from baseline in TAHC and terminal and vellus hair counts in the vertex and right temporal regions at weeks 18 and 26, all as measured by Canfield's Hairmetrix macrophotography system.

Although HST-001 did not achieve statistical significance at the week 18 primary endpoint assessment, the results demonstrated separation from placebo and that patients treated with HST-001 grew new hairs in the vertex region of the scalp while placebo patients lost hairs in the same region during the 18 week evaluation period, noted the company.

The Week 26 final results of the phase Ib/IIa clinical trial of HST-001 are expected in early first quarter of 2021.

HSTO closed Tuesday's trading at $1.31, down 17.61%.

3. Minerva Announces Outcome of Type C Meeting with FDA Related to Roluperidone, Stock Down

Shares of Minerva Neurosciences Inc. (NERV) plunged more than 25% on Tuesday after the company disclosed the outcome of the Type C meeting with the FDA regarding Roluperidone for treatment of negative symptoms in schizophrenia.

In a phase III trial of Roluperidone for the treatment of negative symptoms in schizophrenia, the results of which were reported in May, the 64 mg and 32 mg doses were not statistically significantly different from placebo at Week 12 on the primary endpoint, the PANSS Marder Negative Symptoms Factor Score or the key secondary endpoint, the Personal and Social Performance Scale Total Score. However, Roluperidone separated from placebo on both primary and key secondary endpoints at Weeks 4, 8 and 12.

Minerva held the Type C meeting with the FDA to obtain confirmation from the regulatory agency that, based on the totality of evidence, the data from the phase IIb and phase III studies constitute substantial evidence of the effectiveness of the 64 milligrams (mg) dose of Roluperidone for the treatment of negative symptoms in schizophrenia and would warrant review of an NDA submission.

After reviewing the study results, the FDA cautioned that "an NDA submission based on the current data from the phase IIb and phase III studies would be highly unlikely to be filed and that, at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this indication".

NERV closed Tuesday's trading at $2.89, down 25.71%.

4. OVID Plunges on Failed NEPTUNE Trial

Shares of Ovid Therapeutics Inc. (OVID) plunged more than 50% in extended trading Tuesday, following disappointing results from a phase III trial of OV101 for the treatment of Angelman syndrome, dubbed NEPTUNE.

Angelman syndrome is a rare genetic condition that is characterized by a variety of signs and symptoms like delayed development, intellectual disability, severe speech impairment, problems with movement and balance, seizures, sleep disorders and anxiety. The sole primary endpoint was change in overall score on the Clinical Global Impression-Improvement-Angelman syndrome (CGI-I-AS) scale. Secondary endpoints included sleep, communication, motor function, socialization, daily living skills and behavior domains.

The NEPTUNE study did not meet the primary endpoint and the secondary endpoints continue to be evaluated, although initial results show no difference between OV101 and placebo, the company noted.

OVID closed Tuesday's trading at $6.65, down 2.78%. In after-hours, the stock was down 50.38% at $3.30.

5. Regeneron's Covid-19 antibody cocktail to Be Tested as a Squirt in the Nostril

Regeneron Pharmaceuticals Inc. (REGN) is collaborating with researchers at the University of Pennsylvania to develop an intranasal formulation of the company's Covid-19 antibody cocktail REGEN-COV2 , which can be delivered via adeno-associated virus vectors (AAV).

REGEN-COV2 is a cocktail of two monoclonal antibodies Casirivimab and Imdevimab, administered as a single intravenous infusion. REGEN-COV2 received emergency use authorization from the FDA late last month for recently diagnosed mild to moderate COVID-19 in high-risk patients.

In clinical trials, when REGEN-COV2 is administered via intravenous or subcutaneous injection, the antibody levels have been found to last a month or more. James Wilson, a professor and director of the Penn Gene Therapy Program and the Penn Orphan Disease Center is optimistic that REGEN-COV2 when administered via single dose of AAV will be able to produce similar protection for potentially a longer duration.

As a first step, the effectiveness of the antibodies delivered via AAV in a large animal model challenge study will be validated. For this, the animals will be given the antibody cocktail of REGEN-COV2 via AAV and exposed to the novel coronavirus.
If all goes well, an investigational new drug (IND) application will be filed with the FDA seeking clearance to initiate human trials.

REGN closed Tuesday's trading at $514.07, down 0.38%.

6. FDA Expands Approval of Vanda's Hetlioz to Smith-Magenis Syndrome

The FDA has approved Vanda Pharmaceuticals Inc.'s (VNDA) Hetlioz capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome.

Smith-Magenis Syndrome (SMA) is a rare neurodevelopmental disorder, a defining feature of which is an "inverted" circadian rhythm, making it extremely difficult for these patients to sleep during the night.

Hetlioz in capsule formulation is already approved to treat totally blind adults with non-24-hour sleep-wake disorder. The drug was launched in the U.S. in 2014 and in the EU in 2016.

Non-24-hour sleep-wake disorder is a condition that occurs almost exclusively in people who are completely blind, where patients are unable to synchronize their internal body clock to the standard 24-hour light-dark cycle, and therefore they do not necessarily associate night with sleep, and day with being awake.

The drug generated net product sales of $116.5 million in the first nine months of 2020, compared to $104.4 million in the same period in 2019.

While Hetlioz capsules, for adults with SMS, will be immediately available, Hetlioz LQ liquid formulation, for children with SMS, is expected to be available in the first quarter of 2021.

VNDA closed Tuesday's trading at $12.34, up 1.06%. In after-hours, the stock was up another 6.89% at $13.19.

7. Stocks That Hit New Highs/Lows

Codiak BioSciences Inc. (CDAK) closed Tuesday's trading at an all-time high of $16.41, up 26.13%.

AdaptHealth Corp. (AHCO) closed at a new high of $35.47, up 18.79%.

Beam Therapeutics Inc. (BEAM) closed at a new high of $54.86, up 9.72%.

Histogen Inc. (HSTO) closed at a new low of $1.31, down 17.61%

Progenity Inc. (PROG) closed at a new low of $3.63, down 9.48%.

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