Today’s Daily Dose brings you news about Ampio Pharma’s phase I results of Ampion treatment in COVID-19 patients, Amryt Pharma’s Epidermolysis Bullosa trial results, FDA’s expanded approval for Trelegy Ellipta, Intra-Cellular Therapies’ promising results from bipolar depression trial, Takeda’s disappointing data from TOURMALINE-MM2 trial.
1. COVID-19 patients Treated with Ampio’s Ampion Show Improvement
Ampio Pharmaceuticals Inc.’s (AMPE) phase I trial of intravenous Ampion in adults hospitalized with COVID-19 patients has met its primary endpoint for safety and tolerability.
In the phase I trial, patients were randomized 1:1 to receive IV Ampion treatment or standard of care, including anti-viral therapies, such as Remdesivir or convalescent plasma, both approved by the FDA under emergency use authorization as the standard of care.
According to the company, all patients in the IV Ampion treatment arm showed improvement and at hospital discharge, this group had a stronger clinical improvement than the COVID standard of care control group.
The patients enrolled in the phase I study will be followed up over the coming months to complete the safety endpoint assessments, noted the company.
AMPE closed Wednesday’s trading at $0.73, up 5.03%.
2. Amryt Pharma at EASE
Amryt Pharma plc’s (AMYT) pivotal phase III trial of FILSUVEZ for the treatment of dystrophic and junctional Epidermolysis Bullosa has yielded positive results.
The trial, dubbed EASE, which is the largest phase III trial ever conducted in Epidermolysis Bullosa, achieved the primary endpoint with statistical significance.
Epidermolysis Bullosa is a rare, chronic, and distressing genetic skin disorder that causes the skin layers and internal body linings to separate.
The primary endpoint of the trial was to compare the efficacy of FILSUVEZ versus control gel according to the proportion of patients with complete closure of the target wound within 45 days of treatment.
The company intends to make regulatory submissions for FILSUVEZ in the US and the EU by late Q1 2021.
AMYT closed Wednesday’s trading at $13.50, up 21.84%.
3. FDA Expands Use of Trelegy Ellipta
GlaxoSmithKline plc (GSK) and Innoviva Inc.’s (INVA) Trelegy Ellipta has been approved by the FDA for yet another indication – i.e., for the treatment of asthma in patients aged 18 years and older.
Trelegy Ellipta received its initial FDA approval in September 2017 for the treatment of patients with chronic obstructive pulmonary disease or COPD.
Trelegy Ellipta contains Fluticasone furoate, an inhaled corticosteroid, Umeclidinium, a long-acting muscarinic antagonist; and Vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler.
Following Wednesday’s expanded FDA approval, Trelegy becomes the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the U.S.
GSK closed Wednesday’s trading at $39.75, up 2.00%. In after-hours, the stock gained another 1.11% and was at $40.19.
4. Intra-Cellular Therapies’ Bipolar Depression Trial Results Impress Investors
Shares of Intra-Cellular Therapies Inc. (ITCI) jumped over 72% Wednesday, following positive topline results from its phase III study of Lumateperone as adjunctive therapy in patients with bipolar depression.
In the trial, dubbed Study 402, Lumateperone of dosages 42 mg and 28 mg or placebo were evaluated as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.
According to trial results, once-daily Lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score as well as the key secondary endpoint, the CGI-BP-S Depression Score.
In other news, the company announced that it has commenced an underwritten public offering of $350 million of shares of its common stock.
ITCI closed Wednesday’s trading at $31.86, up 72.87%.
5. Sonoma Launches New Oral and Nasal Care Products
Sonoma Pharmaceuticals Inc. (SNOA), along with its partner Te Arai BioFarma Ltd., has launched two new products – Nasocyn Nasal Care and Oracyn Oral Care – in Australia.
The two products are based on Sonoma’s patented Microcyn and Microdacyn technology and are available without prescription through pharmacies.
Nasocyn Nasal Care, which clears and cleans blocked nasal passages and sinus cavities, is used for preventative and symptomatic care against cold and flu. Oracyn, which is used as a mouth wash, gargle, or rinse, helps treat infections in the throat and mouth.
SNOA closed Wednesday’s trading at $6.79, up 4.30%. In after-hours, the stock was up another 18.85% at $8.07.
6. Takeda’s TOURMALINE-MM2 trial for Newly Diagnosed Multiple Myeloma Fails
Takeda Pharmaceutical Company Ltd.’s (TAK) phase III trial of its drug NINLARO in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant, dubbed TOURMALINE-MM2, has not met the key goal.
In the trial, the addition of NINLARO to lenalidomide and dexamethasone was compared against lenalidomide and dexamethasone plus placebo. Although the addition of NINLARO to lenalidomide and dexamethasone resulted in a 13.5-month increase in median progression-free survival in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant, the trial did not meet the threshold for statistical significance and the primary endpoint of progression-free survival was not met.
Takeda’s NINLARO is currently approved in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in more than 65 countries. The drug is not approved as a treatment for newly diagnosed multiple myeloma.
TAK closed Wednesday’s trading at $18.06, up 0.50%.
7. Stocks That Moved On No News
Precipio Inc. (PRPO) closed Wednesday’s trading at $2.86, up 21.19%.
Retractable Technologies Inc. (RVP) closed Wednesday’s trading at $6.47, up 19.37%.
Ontrak Inc. (OTRK) closed Wednesday’s trading at $80.32, up 16.42%.
Co-Diagnostics Inc. (CODX) closed Wednesday’s trading at $10.22, down 12.65%.
Inozyme Pharma Inc. (INZY) closed Wednesday’s trading at $25.46, down 10.98%.
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