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Details:
Aviptadil is a synthetic form of vasoactive intestinal peptide (VIP) that, when administered, results in rapid clinical recovery in patients with severe SARS-COV-2 infection. Biophore has successfully developed aviptadil and is backward integrated with in-house API.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Biophore has developed Aviptadil and is backward integrated with in-house API. The company has also informed that it will be commencing commercial production immediately after the approval is received.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
RLF-100® (aviptadil acetate) restores barrier function at the endothelial/alveolar interface and thereby protects the lung and other organs from failure. It is under development for the potential treatment of acute and chronic lung disease.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 17, 2023
Details:
Zyesami (aviptadil acetate) is an inhaled formulation of synthetic human Vasoactive Intestinal Polypeptide (VIP) in development for the treatment of patients with critical COVID-19 respiratory failure.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 19, 2022
Details:
APR-TD011 has potential for the treatment of wounds in epidermolysis bullosa ("EB"), a group of rare, genetic, life-threatening connective tissue disorders characterized by fragile skin and mucous membrane with severe blistering throughout the body.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Agreement November 14, 2022
Details:
RLF-100® (aviptadil) is a synthetic form of Vasoactive Intestinal Peptide (“VIP”) consisting of 28 amino acids. The reported data demonstrated high purity levels at six months at all temperatures tested, including at refrigerated and room temperature environments.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2022
Details:
RLF-100® (aviptadil) is a synthetic form of Vasoactive Intestinal Peptide ("VIP") consisting of 28 amino acids, is under development for certain acute and chronic lung diseases, including pulmonary sarcoidosis.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Details:
Zyesami (aviptadil acetate) is an inhaled formulation of synthetic human Vasoactive Intestinal Polypeptide (VIP) in development for the treatment of patients with critical COVID-19 respiratory failure.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2022
Details:
ZYESAMI (aviptadil), is an inhaled formulation of synthetic human Vasoactive Intestinal Polypeptide (VIP) in development for the treatment of patients with critical COVID-19 respiratory failure.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Psychiatry/Psychology Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
The primary endpoint (90 day 6-category ordinal score) was not supportive (OR 1.10; 0.79 – 1.54; p=0.56), and 90-day mortality secondary endpoint was also not supportive with 37% mortality in Zyesami (aviptadil) group vs 36% in the placebo group; HR 1.04 (0.77-1.41); p=0.79.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2022
Details:
Breakthrough Therapy designation was requested based on data from post-hoc analysis of patients who in addition to Aviptadil or placebo were also treated with Remdesivir and whose respiratory failure due to Critical COVID-19 continued to progress.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2022
Details:
Aviptadil is a synthetic form of Human Vasoactive Intestinal Polypeptide and was selected because of the potential to reduce inflammation and stabilize the air sacs of hospitalized because of injury from acute respiratory distress syndrome, which is the major cause of death.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: NRx Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
The provisional patent application describes composition of vasoactive intestinal peptide, the synthetic form of ZYESAMI (aviptadil acetate), both are shelf-stable and biologically active when used to treat COVID-19 and other diseases.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2022
Details:
NRx and Hungary Agree on Regulatory Path for Emergency Use of ZYESAMI (aviptadil) a synthetic version of Vasoactive Intestinal Polypeptide for the Treatment of Severe COVID-19.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2021
Details:
Analysis was conducted in the subgroup of ZYESAMI- and placebo-treated patients who were previously treated with remdesivir in the COVID-AIV trial representing approximately 70 percent of the study population.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2021
Details:
Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2021
Details:
The FDA was unable to issue the EUA due to insufficient data regarding the known & potential benefits of the medicine and the known & potential risks of ZYESAMI in patients suffering from Critical COVID-19 with respiratory failure on the basis of ongoing NIH ACTIV-3b trial.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2021
Details:
Aviptadil-treated participants in this open-label study demonstrated a rapid (48-96 hour) 2-fold improvement in the Respiratory Distress Ratio. Aviptadil is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) used for COVID-19-related respiratory failure.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2021
Details:
Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2021
Details:
ACTIV-3b is a randomized, placebo-controlled trial testing ZYESAMI™ and remdesivir (Veklury) -- alone and in combination -- in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen delivered by nasal cannula.
Lead Product(s): Aviptadil Acetate,Remdesivir,Dexamethasone
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2021
Details:
This collaboration will allow NRx to access IQVIA’s domain experience with COVID-19, our unparalleled data assets, and analytics to support potential emergency use authorization (EUA) of ZYESAMI.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: IQVIA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 13, 2021
Details:
ZYESAMI™ (aviptadil) is a proprietary, synthetic version of Vasoactive Intestinal Peptide or VIP, which is made naturally in the human body and appears to have lung-protective, anti-viral and anti-inflammatory effects.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2021
Details:
ZYESAMI™ (aviptadil) was awarded Fast Track Designation by the U.S. Food and Drug Administration for the Treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome Associated with COVID-19. Development will be based on MannKind’s proven Technosphere® platform.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: NRx Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 04, 2021
Details:
The first doses of ZYESAMI™ will arrive in the Nation of Georgia within 24 hours, and discussions are underway with the Ministry of Health to provide access to ZYESAMI™ to Georgians suffering with Critical COVID-19.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2021
Details:
The cytokine data were collected as part of the phase 2b/3 trial of ZYESAMI™ (aviptadil) compared to placebo, in critically ill patients with COVID-19 respiratory failure.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2021
Details:
NRx also announced that the ongoing phase 2/3 trial for the use of inhaled ZYESAMI™ has extended to Georgia, with the potential to also extend to neighboring countries in the Caucasus region.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2021
Details:
Cromos will support NRx in the development of ZYESAMI™ (Aviptadil acetate) for home treatment of COVID-19, working to reduce the incidence of hospitalization and death.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: NRx Pharmaceuticals
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration May 26, 2021
Details:
NeuroRx has met with Dr. Ekaterine Tikaradze, Minister of Health of Georgia, and other senior leadership, to immediately initiate an Expanded Access Program (EAP) of its phase 3 drug, ZYESAMI for critically-ill citizens of Georgia with COVID-19 Respiratory Failure.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Denk Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 28, 2021
Details:
ACTIV-3b is a placebo trial which is going to study Zyesami – which is a synthetic version of a vasoactive peptide – and remdesivir alone and in combination against a placebo.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2021
Details:
The randomized clinical trial is called ACTIV-3 Critical Care. It will begin by testing Zyesami, a formulation of aviptadil acetate, produced by NeuroRx, Wilmington, Delaware, and the antiviral remdesivir, developed by Gilead, Foster City, California.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2021
Details:
Relief Therapeutics and AdVita Lifescience are set to enrol the first patient in a Phase II trial of an inhaled formulation of the former’s lead compound, RLF-100 (aviptadil), for preventing Covid-19-related acute respiratory distress syndrome (ARDS).
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Advita
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2021
Details:
According to NeuroRx, across all patients and sites, RLF-100(TM) met the primary endpoint for successful recovery from respiratory failure at days 28 and 60 and also demonstrated a meaningful benefit in survival after controlling for ventilation status and treatment site.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: NRx Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2021
Details:
According to the latest 60-day results, Zyesami met the primary endpoint of successful recovery from respiratory failure at day 28 in all subjects and showed a meaningful survival benefit after controlling for ventilation status and treatment site.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2021
Details:
The study showed that patients who were treated with the maximal standard of care plus ZYESAMI were discharged sooner from the hospital compared to those treated with placebo plus maximal standard of care (SOC).
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2021
Details:
NeuroRx has initiated a Phase II/III clinical trial of its inhaled Zyesami (previously RLF-100: aviptadil) for treating patients with severe Covid-19.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: University of California
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2021
Details:
Relief will gain further pending intellectual property rights that may cover RLF-100TM inhaled formulation specifications and the potential application of inhaled Aviptadil in the treatment of Acute Respiratory Distress Syndrome and Checkpoint Inhibitor-induced Pneumonitis.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: $2.4 million Upfront Cash: Undisclosed
Deal Type: Acquisition January 20, 2021
Details:
The objective of the current study is to determine whether RLF-100™, administered at the earlier (severe) stage of COVID-19 can reduce the likelihood of progression to critical COVID-19 with respiratory failure: the predominant cause of death in COVID-19-infected individuals.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2021
Details:
Half-century-old aviptadil, studied over the years for a variety of uses including erectile dysfunction and pulmonary fibrosis, was part of Relief's portfolio when the COVID-19 pandemic began, prompting the company to test it against the new coronavirus.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2020
Details:
NeuroRx and Relief Therapeutics have met the 165 patient enrollment target agreed with the U.S. Food and Drug Administration (FDA) in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil) for treating Respiratory Failure in patients with Critical COVID-19.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2020
Details:
Relief, NeuroRx have met the 165 patient enrollment target agreed with the U.S. Food and Drug Administration (FDA) in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil) for treating Respiratory Failure in patients with Critical COVID-19.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: NRx Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
The committee identified no safety concerns and viewed the study as capable of reaching its prespecified endpoint in potentially proving that RLF-100™ is superior to placebo in achieving recovery from Respiratory Failure in patients with Critical COVID-19.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
Overall, 81% of RLF-100™-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100™ demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Details:
NeuroRx and Relief, are leading US and EU commercialization plans. They have now contracted with Nephron Pharmaceuticals to manufacture commercial supplies of RLF-100™ to ensure sufficient supplies to treat 1 million patients, should the drug prove effective in the studies.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 30, 2020
Details:
Patients treated with RLF-100™ demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2020
Details:
The two organizations have agreed to share all profits from sales of RLF-100 for all indications related to COVID-19 and potentially other respiratory indications on a global basis.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: NRx Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 21, 2020
Details:
NeuroRx has been granted Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
The protocol makes treatment available to patients who have exhausted standard therapies and are not eligible for the current phase 2/3 trial of RLF-100 because of confounding medical conditions and specifically makes the treatment available to pregnant women.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns that would mandate stopping. The study is to continue until the next scheduled data review in four weeks.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns that would mandate stopping. The study is to continue until the next scheduled data review in four weeks.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
Fast Track Designation of RLF-100 for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19 underscores the urgent need for new treatment options for these patients.
Lead Product(s): Aviptadil Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: RLF-100
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
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Market Place
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
