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GILD Seeks To Revoke Coveted Status, ELOX Pauses Trial, PRQR On Watch

pharma 050517 26mar20 lt

Today's Daily Dose brings you news about Immutep's breast cancer trial results, ProQR Therapeutics' near-term catalyst, Eloxx Pharma pausing patient enrolment in its cystic fibrosis trial, Jazz Pharma's regulatory catalyst and Gilead seeking to revoke the coveted status for potential COVID-19 drug.

Read on…

Eloxx Pharmaceuticals Inc. (ELOX) has temporarily paused enrollment in its phase II clinical trials for ELX-02 in cystic fibrosis in response to the COVID-19 pandemic.
The company noted that cystic fibrosis patients, especially those with nonsense mutations, have compromised lung function and may be at increased risk of severe illness in the event of a COVID-19 infection.

Yesterday, Ampio Pharmaceuticals Inc. (AMPE) suspended patient enrollment in its phase III clinical trial of Ampion for the treatment of severe osteoarthritis of the knee due to the pandemic.

ELOX closed Wednesday's trading at $2.10, down 16.00%.

Barely two days after getting the coveted status of "Orphan Drug" for its investigational antiviral Remdesivir for the treatment of COVID-19, Gilead (GILD) has requested the FDA to rescind that designation.

The Orphan Drug designation not only entitles the manufacturer of that drug millions of dollars in government incentives, but it also gives seven-year market exclusivity for that drug.

Gilead has under come under sharp criticism for securing Orphan drug status for its potential treatment for COVID-19.

A number of companies are working on developing a drug for the novel coronavirus. As of this writing, worldwide, there have been 471,688 confirmed cases of COVID-19 infection and 21,297 deaths. (Source: Worldometer).

GILD closed Wednesday's trading at $69.66, down 5.81%.

Immutep Limited (IMMP) said that its phase IIb clinical trial of its lead product candidate, Eftilagimod alpha, in combination with Paclitaxel, a taxane standard of care chemotherapy, dubbed AIPAC, has demonstrated clinical benefit in HR-positive metastatic breast carcinoma in multiple patient subgroups.

According to the trial results, 63% of patients who received paclitaxel plus efti were progression-free at the 6-month landmark compared to 54% of patients who received paclitaxel plus placebo. The PFS data yielded an unadjusted hazard ratio (HR) of 0.93.

The secondary endpoint of Overall Response Rate (ORR) increased to 48.3% in the efti group, from 38.4% in the placebo group.

The immuno-monitoring data and Overall Survival data from the AIPAC trial are expected to be available by the end of this year.

IMMP closed Wednesday's trading at $0.88, down 52.28%.

Jazz Pharmaceuticals plc's (JAZZ) New Drug Application seeking marketing approval for JZP-258 has been accepted for priority review by the FDA, with a decision date set for July 21, 2020.

JZP-258 is proposed for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

Narcolepsy is a chronic, debilitating neurological disorder characterized by EDS and the inability to regulate sleep-wake cycles normally. Cataplexy, the most specific symptom of narcolepsy, is the sudden, generally brief (less than 2 minutes) loss of muscle tone with retained consciousness. It is usually triggered by strong emotions, such as laughter, surprise, or anger.

Xyrem, also from the stable of Jazz Pharma, is the only available product approved to treat both cataplexy and EDS in patients with narcolepsy ages 7 years and older and is the standard of care for treatment of cataplexy.

JZP-258 has 92% less sodium than Xyrem. Since lowering sodium intake lowers the risk of cardiovascular disease, JZP-258, if approved, will provide a clinically meaningful benefit to patients prescribed Xyrem.

JAZZ closed Wednesday's trading at $95.64, up 0.02%.

ProQR Therapeutics N.V. (PRQR) is slated to present findings from a planned three-month interim analysis of its Phase 1/2 trial of QR-421a in adults with Usher syndrome and non-syndromic retinitis pigmentosa on March 31, 2020.

The findings will be announced in a press release and management will host an investor conference call at 8:15 a.m. ET the same day to discuss the results in detail.

The trial, dubbed Stellar, is a first-in-human, 24-month study exploring the safety and efficacy of a single intravitreal injection of several dose levels of QR-421a in adults who have vision loss due to mutations in exon 13 of the USH2A gene.

PRQR closed Wednesday's trading at $5.95, down 5.41%.

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