AUPH Faces FDA In Jan, ARCT To Advance LUNAR-COV19 Vaccine, IFRX On Watch, All Eyes On ALEC

biotech 0722

Today's Daily Dose brings you news about Aurinia Pharma's near-term regulatory catalyst, Alector gearing up to report frontotemporal dementia trial results next week, the progress in Arcturus' LUNAR-COV19 vaccine, Biohaven completing enrolment in phase III trial of Verdiperstat in multiple system atrophy, and InflaRx' update on its investigational drug IFX-1 in severe COVID-19- induced pneumonia patients, among others.

Read on…

1. Aurinia to Face FDA in January

Aurinia Pharmaceuticals Inc.'s (AUPH) (AUP.TO) New Drug Application seeking approval of Voclosporin as a treatment for lupus nephritis has been accepted for priority review by the FDA, with a decision date set for January 22, 2021.

Lupus nephritis is an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE.

Voclosporin as an ophthalmic solution is under a phase II/III trial for the potential treatment of dry eye syndrome, dubbed AUDREY. Data from this trial is expected in the fourth quarter of this year.

AUPH closed Tuesday's trading at $14.48, down 3.85%. In after-hours, the stock was up 9.12% at $15.80.

2. Will INFRONT Data bring Alector to the forefront?

Alector Inc. (ALEC) is all set to present preliminary data from a phase II study evaluating AL001 in individuals with frontotemporal dementia with specific genetic mutations, including the granulin gene (FTD-GRN), on July 28 at the upcoming 2020 Alzheimer's Association International Conference being held virtually, July 27-31, 2020.

The phase II study, dubbed INFRONT, was initiated last September.

Frontotemporal dementia (FTD) is a form of dementia found most frequently in individuals less than 65 years old at the time of diagnosis. FTD affects roughly 50,000 to 60,000 individuals in the United States and roughly 110,000 individuals in the European Union. This rapidly progressing degenerative syndrome is characterized by prominent cognitive dysfunction, behavioral and personality changes, and language deficits.

The company has plans to initiate a pivotal phase III trial of AL001 in patients with frontotemporal dementia with a progranulin mutation (FTD-GRN) this year.

ALEC closed Tuesday's trading at $21.38, down 9.83%. In after-hours, the stock was up 5.24% at $22.50.

3. Arcturus Getting Ready To Advance LUNAR-COV19 Vaccine

Arcturus Therapeutics Holdings Inc. (ARCT) and Singapore's Duke-NUS Medical School may soon advance their coronavirus vaccine candidate LUNAR-COV19 into phase I/II trial.

The LUNAR-COV19 vaccine has been approved to proceed into human clinical trials by the Singapore Health Sciences Authority. This vaccine candidate is based on Arcturus' STARR technology and a unique platform developed at Duke-NUS.

The phase I/II trial will evaluate several dose levels of LUNAR-COV19 in up to 108 healthy adults, including older adults. Follow-up will be conducted to evaluate safety, tolerability and the extent and duration of the humoral and cellular immune response, according to Arcturus & Duke-NUS.

ARCT closed Tuesday's trading at $57.55, down 1.15%.

4. Biohaven Completes Enrollment in M-STAR; Results By 2021-end

Biohaven Pharmaceutical Holding Company Ltd. (BHVN) has successfully completed enrollment in an international phase III trial evaluating Verdiperstat in multiple system atrophy, dubbed M-STAR.

Multiple system atrophy is a rare, rapidly progressive, and fatal neurodegenerative disease that leads to death within a median of 6-10 years after receiving a diagnosis, often due to cardiac or respiratory complications. This disease affects roughly 50,000 people in the United States and Europe alone.

The M-STAR trial, which has a duration of 48 weeks, has enrolled about 300 patients, with topline data anticipated by the end of 2021.

BHVN closed Tuesday's trading at $72.53, down 1.43%.

5. Cerecor Marches Ahead

Cerecor Inc. (CERC) has enrolled the first patient in a proof-of-concept trial evaluating its anti-LIGHT monoclonal antibody, CERC-002, in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome.

The trial is designed to enroll roughly 82 subjects hospitalized with COVID-19 Acute Respiratory Distress Syndrome. The primary objective of the study is to demonstrate that treatment with CERC-002 results in fewer instances of respiratory failure and death versus the standard of care.

The company expects to report top-line data from the COVID-19 trial in the fourth quarter of 2020.

CERC closed Tuesday's trading at $3.06, up 10.87%.

6. CytoDyn Awaits Efficacy Data from Covid-19 Trial

CytoDyn Inc.'s (CYDY.OB) phase II trial of Leronlimab in COVID-19 patients has yielded favorable safety results. The efficacy results are expected to be released soon.

The phase II study enrolled a total of 84 patients, with 56 patients assigned to the Leronlimab arm and 28 patients to the placebo arm. This trial was designed to evaluate the safety and efficacy of Leronlimab.

According to the trial results, 34% (19 of 56 patients) treated with Leronlimab compared to 50% (14 of 28 patients) treated with placebo reported at least one adverse event. Moreover, 39% (11 of 28 patients) in the placebo arm compared to only 14% (8 of 56 patients) in Leronlimab arm reported serious adverse events (SAEs), which were unrelated to Leronlimab.

The significant reduction in SAEs in the Leronlimab group ultimately translates into improved patient clinical outcomes, according to the company.

CYDY.OB closed Tuesday's trading at $5.72, down 9.78%.

7. InflaRx' IFX-1 Halves Mortality Rate In COVID-19 induced Pneumonia patients

InflaRx (IFRX) has decided to advance its investigational drug IFX-1 in severe COVID-19- induced pneumonia into phase III stage, based on initial data from the randomized exploratory phase II part of the phase II/III trial.

In the phase II part of the trial that enrolled a total of 30 severe COVID-19 induced pneumonia patients, the 28-day all-cause mortality rate was 13% who received IFX-1 treatment plus best supportive care while the mortality rate was 27% in patients who received the best supportive care alone.

In the planned phase III part of the study, subject to regulatory approval, about 360 early intubated, critically ill patients with COVID-19 induced pneumonia will be enrolled. The study sites include US, Europe, South America, and potentially other regions.

IFRX closed Tuesday's trading at $5.23, up 1.75%.

8. Ironwood Updates Phase III program of IW-3718

Ironwood Pharmaceuticals Inc. (IRWD) has provided an update on its phase III program of IW-3718 in adults with refractory gastroesophageal reflux disease.

The phase III program consists of two identical multicenter trials of IW-3718, dubbed IW-3718-301, and IW-3718-302.

The primary endpoint for the phase III trials has now been set as the change from baseline to week 8 in weekly heartburn severity scores. Previously, it was an overall heartburn responder (defined as a patient who experiences at least a 45% reduction from baseline in heartburn severity for at least four out of eight weeks, including at least one of the last two weeks).

The company also expects to conduct an early assessment of the IW-3718-302 trial and report the outcome of the assessment in the fourth quarter of 2020.

IRWD closed Tuesday's trading at $9.86, down 6.98%.

9. Immuron Rallies for a Second Day

Shares of Immuron Limited (IMRN) rose as much as over 100 percent to $21.30 in intraday trading Tuesday, following news that IMM-124E, used to manufacture the company's flagship commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan and Protectyn, has demonstrated neutralizing activity against the COVID-19 virus in laboratory studies.

Although the respiratory system is the main target of SARS-CoV-2, there is growing clinical evidence to suggest that the gastrointestinal tract may present another viral target organ. The company believes that IMM-124E offers a new oral therapeutic approach to target and directly inhibit the virus in the gastrointestinal tract and warrants further evaluation.

In other news, the company has entered into definitive agreements with several healthcare-focused institutional investors for the purchase and sale in a registered direct offering of 1.06 million American Depositary Shares at a purchase price of $18.75 per ADS. The closing of the offering is expected to occur on or about July 23, 2020, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be about $20 million.

IMRN closed Tuesday's trading at $14.81, up 42.27%.

10. Stocks That Moved On No News

Onconova Therapeutics, Inc. (ONTX) closed Tuesday's trading at $1.39, up 27.52%.

TherapeuticsMD Inc. (TXMD) closed Tuesday's trading at $2.24, up 20.43%.

Eyenovia Inc. (EYEN) closed Tuesday's trading at $3.47, up 18.03%.

Biomerica Inc. (BMRA) closed Tuesday's trading at $9.11, down 24.34%.

Denali Therapeutics Inc. (DNLI) closed Tuesday's trading at $24.69, down 12.58%.

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