CODX On Fire, MNLO Plunges On Serlopitant Data, VIR Enters COVID-19 Vaccine Race

Today’s Daily Dose brings you news about Menlo’s Serlopitant trial results, Novavax’s update on its efforts to develop a novel vaccine against coronavirus disease COVID-19, Oramed’s oral insulin trial results and Vir Biotech’s entry into coronavirus vaccine development space.

Read on…

Shares of Co-Diagnostics Inc. (CODX) continued to rally on Wednesday, touching a new 52-week high, following the CE Mark receipt for its Logix Smart Coronavirus COVID-19 Test.

The Logix Smart Coronavirus COVID-19 Test is to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of SARS-CoV-2 (COVID-19) in markets that accept CE-marking as valid regulatory approval, and is now available for purchase from the Company’s Utah-based ISO-13485:2016 certified facility.

Dwight Egan, Chief Executive Officer of Co-Diagnostics, remarked, “We believe Co-Diagnostics is the first U.S. Company to receive a CE-marking for a coronavirus IVD, which is a testament to the quality of our platform”.

CODX touched a new 52-week high of $10.89 in intraday trading before closing at $8.90, up 106.26%.

Menlo Therapeutics Inc.’s (MNLO) phase II trial of Serlopitant in chronic pruritus of unknown origin is the latest to join the list of failed Serlopitant trials.

According to the results reported on Wednesday, the trial, which included 233 patients, did not meet its primary endpoint to show a statistically significant reduction in pruritus in patients treated with Serlopitant compared to placebo based upon a 4-point improvement responder analysis.

In the trial, 37.9% of patients in the Serlopitant group achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 10 compared to baseline versus 39.3% of patients treated with placebo.

In April 2018, Menlo’s phase II clinical trial of Serlopitant for the treatment of pruritus in adults and adolescents with a history of atopic dermatitis, dubbed ATOMIK, did not meet its primary or key secondary efficacy endpoints.

Another phase II study that failed in 2018 was TUSSIX, which evaluated Serlopitant for the treatment of refractory chronic cough.

Near-term Catalysts:

— Two phase III clinical trials – one in the U.S. and one in Europe – evaluating Serlopitant as a treatment for pruritus associated with Prurigo Nodularis are underway, with results expected in March or April of 2020.
— FMX103, an investigational drug for rosacea, from the stable of Foamix is at the FDA altar, awaiting a decision on June 2, 2020.
— A phase II clinical trial of FCD105, also from the stable of Foamix, for treatment of moderate to severe acne, is underway, with top-line data expected in mid-2020.

MNLO closed Wednesday’s trading at $2.98, down 32.27%.

Shares of Novavax Inc. (NVAX) soared as much as 41 percent on Wednesday after the Company updated its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19.

The Company said it is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of Spring 2020. (i.e. by May).

The Company has a clinical trial catalyst to watch out for this quarter.

A phase III clinical trial evaluating the immunogenicity and safety of NanoFlu against the quadrivalent formulation of Fluzone is underway. The trial’s primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to Fluzone, and to describe its safety profile.

The top-line clinical data from the trial is expected by the end of the first quarter of 2020. If all goes well as planned, the Company may seek approval of NanoFlu using the FDA’s accelerated approval pathway.

NVAX closed Wednesday’s trading at $9.22, up 15.97%. In after-hours, the stock gained another 10.09% and was at $10.15.

Oramed Pharmaceuticals Inc.’s (ORMP) second and final cohort of phase IIb trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, at lower dose regimens, has yielded positive results.

The primary efficacy endpoint of the trial is the change in A1C, from baseline to week 12, as well as safety endpoints, when ORMD-0801 was given in different regimens across three daily dose ranges (8 mg, 16 mg, 32 mg).

Patients randomized in the trial treated with 8 mg of ORMD-0801 once daily achieved an observed mean reduction of 1.29% in A1C from baseline and a least square mean reduction of 0.95% from baseline. Patients who had A1C readings above 9% at baseline and received 8 mg of oral insulin once daily experienced a 1.26% reduction in A1C by week 12, noted the Company.

In other related news, the Company announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

ORMP closed Wednesday’s trading at $4.70, down 3.49%.

Vir Biotechnology Inc. (VIR) has entered into a development and manufacturing collaboration and WuXi Biologics, a Hong Kong-listed company, to advance and produce human monoclonal antibodies for the potential treatment of COVID-19 (Coronavirus Disease 2019).

Vir Biotechnology is a clinical-stage immunology company focused on treating and preventing serious infectious diseases. It has identified a number of monoclonal antibodies that bind to SARS-CoV-2. These antibodies were isolated from individuals who had survived a SARS (Severe Acute Respiratory Syndrome) infection. The Company is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.

Under the terms of the agreement inked on Wednesday, the two companies will work together on the clinical development, manufacturing, and commercialization of Vir’s proprietary antibodies.

WuXi Biologics will conduct cell-line development, process and formulation development, and initial manufacturing for clinical development. If the antibodies receive regulatory approvals, WuXi Biologics has the rights to commercialize therapies in Greater China, and Vir has the rights to commercialize therapies in all other markets worldwide.

More info about VIR’s pipeline can be found in our report titled “Will Vir Biotech (VIR) Experience Better Fortune In 2020?”

VIR closed Wednesday’s trading at $34.97, up 60.95%.

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