Healthcare Roundup – Remdesivir has little effect on mortality, Gilead Science lands WHO distinction for remdesivir

Published on: October 16, 2020
Author: Amy Liu

Remdesivir has little effect on mortality according to WHO study – FT

Gilead’s COVID-19 treatment Remdesivir had “no substantial effect” on the survival of hospitalized patients, a WHO study seen by the FT found.

But the not-yet-published study was not originally designed to assess the impact of in-hospital mortality, the FT reports.

Gilead (NASDAQ:GILD) shares -1.6% dropped quickly after the article was published but have recovered.

“We are aware that initial data from the World Health Organization’s SOLIDARITY Trial has been made public prior to publication in a peer-reviewed journal,” Gilead told the FT. “The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit of (remdesivir).”

A similar lack of impact was found in regimes of hydroxychloroquine, lopinavir and interferon.

Gilead Science lands WHO distinction for remdesivir

Gilead Sciences’ (GILD -1.7%) remdesivir has been added to the prequalified list by the World Health Organization for COVID-19

The WHO filing indicates remdesivir was prequalified for a dosage form of powder for solution strength of 100mg per injection.

President Trump received remdesivir in addition to REGN-COV2 and the dexamethasone steroid as part of his COVID-19 treatment.

Last week, Gilead Sciences and the European Commission signed a joint procurement agreement that will enable rapid and equitable access to remdesivir.

Apellis on go with mid-stage COVID-19 study with C3 inhibitor

Apellis (APLS -2.0%) has announced preliminary results from the first part of Phase 1/2 study of APL-9, a C3 inhibitor in patients with severe COVID-19.

Of the six patients enrolled, all patients had elevated C3a and C-reactive protein (CRP) levels and five of the six patients had elevated lactate dehydrogenase (LDH) levels at baseline. Five patients completed the study, and in these patients, C3a, LDH and CRP levels were within the normal range by the end of the APL-9 treatment period.

Three patients experienced four treatment-emergent adverse events, which were all considered unrelated to study treatment. One serious adverse event of respiratory failure, which was considered unrelated to the study treatment, led to death from failed intubation.

Based on the results, an independent data monitoring committee has recommended to continue evaluating the safety and efficacy of APL-9 (as add-on to standard care for up to 21 days).

Apellis is currently enrolling an additional 60 patients with COVID-19 and respiratory failure who require oxygen supplementation or mechanical ventilation.

Additionally, the company conducted 41-patient observational study, that demonstrated increased complement activation was correlated with COVID-19 severity. Similar correlation was observed with LDH, CRP and cytokine interleukin 6 (IL-6) levels.

In addition, 97.5% patients had substantially elevated systemic levels of C3a, a marker for C3 activation, with median C3a levels 3.7 times the upper limit of normal.

Tenax Therapeutics gains North American rights to oral levosimendan; shares +14%

Tenax Therapeutics (NASDAQ:TENX) +14% premarket, has amended its existing licensing agreement with Orion Corporation to include the rights to develop and commercialize an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other heart disorder related indications in the U.S. and Canada.

The Company recently completed a Phase 2 study in PH-HFpEF using an intravenous formulation of levosimendan, which the Company has exclusive rights to in U.S. and Canada under the existing license agreement.

Tenax now plans to utilize the oral formulation in its upcoming Phase 3 trial in PH-HFpEF. Currently, there are no approved products for treating PH-HFpEF.

“Use of the currently available 1mg capsule of levosimendan should allow us to conduct our upcoming Phase 3 trial with significantly faster enrollment versus the IV formulation,” stated CEO Anthony DiTonno.

The amendment allows Tenax to access all of the manufacturing, preclinical and clinical data generated on oral levosimendan to support its use in the US and Canada.

Kiromic Bio prices IPO at $12

Kiromic BioPharma (KRBP) has priced its IPO of 1.25M common shares at $12.00/share, for gross proceeds of $15M.

Underwriters’ over-allotment is an additional 187.5K shares.

Trading kicks off October 16.

ThinkEquity is acting as sole book-running manager. Paulson Investment Company is acting as co-manager.

Closing date is October 20.

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