Passion - Teamwork - Expertise

  • Our Passion: "Helping people suffering from lung disease."

  • Our Teamwork: "Nobody does it all by themselves. Everybody counts."

  • Our Expertise: "We've spent our careers in lung disease. The work is still not done."

 

Pulmonary diseases are on the rise, and mean a substantial burden on patients, caregivers, and society. Specific unmet needs are still present in the areas of Cystic Fibrosis, Asthma and COPD.

 

We at Qrumpharma are driven by helping those patients and society by using good science that leads to good clinical development. Ultimately, it is our goal to improve people's lives with intelligent and ethical application of clinical science. Our team of experienced drug development professionals is working virtually, and brings a long history of successful drug development in the pulmonary space, along with regulatory expertise, and understanding of the business needs.

About Us

 

Qrumpharma is a Pennsylvania-based preclinical pharmaceutical firm focused on developing first-in-class therapeutics for the treatment of severe chronic and recurrent infections and diseases, such as:

 

  • Cystic Fibrosis (CF) pulmonary infections
  • Nontuberculous Mycobacteria infections – in CF and non-CF
  • Ventilator-associated pneumonia (VAP)

 

Based on innovative technology and founded by experienced entrepreneurs we develop novel treatments for bacterial infections in order to change the lives of patients around the world. Driven by unmet medical needs, we may re-formulate antibiotics for inhalation, or license and develop novel drugs to accomplish our goals.

Biofilm Therapeutic Areas

 

Cystic Fibrosis

Cystic fibrosis is an autosomal recessive genetic disorder that affects multiple organs, and is characterized by abnormal transport of chloride and sodium across the epithelium, leading to thick, viscous secretions. This results in frequent and chronic lung infections that requires treatment with antibiotics and other medications, both systemic and inhaled. The main burden of disease is the lung and pulmonary complications, with difficulty breathing as a hallmark of the disease.

 

Biofilm in CF

Biofilms are multicellular colonies of individual - so-called planktonic - bacteria that have banded together in response to an attack. Once formed into a large enough group, the individual bacteria work together to secrete a protective extracellular matrix that, protects the colony from by both the immune system and applied antibiotics like a castle wall. Along with other properties this biofilm extracellular matrix results in the bacterial infection being extremely difficult and recalcitrant to eradicate; as much as thousand times the concentration of conventional antibiotics are required to fully eradicate a biofilm infection. Biofilms significantly contribute to the spread of antibiotic resistant bacterial pathogens ("superbugs"). Because of continual exposure but not eradication of the bacteria, which is protected within the biofilm, the risk of developing genetic resistance to conventional antibiotics increases. It is now understood that these individual planktonic bacteria are able to communicate and cooperate as a group through a process called quorum sensing.

 

Due to the production of abnormally thick sputum, CF patients are frequently afflicted by pulmonary infections which lead to destruction of lung tissue and eventually death via lung failure; the median lifespan for a CF patient is 41.2 years although this is increasing dramatically as treatment improves. The CF prevalent population is growing at annualized compounding growth rate of 1.5 % ± 0.5%. While many bacterial species infect CF patients overtime, by far the most clinically relevant pathogen is Pseudomonas aeruginosa. Despite the fact that CF patients continually use potent conventional broad spectrum antibiotics such as inhaled tobramycin (TOBI®) and aztreonam (Cayston®), it is now recognized that these antibiotics fail to eradicate chronic Pseudomonas aeruginosa pulmonary infections due to biofilm.

 

Qrumpharma is in the process of developing novel approaches in the above indications, and will announce specfics of those programs shortly.

Nontuberculous mycobacteria

 

Background on NTM and Qrum program

Nontuberculous mycobacteria (NTM) infections in Cystic Fibrosis are a serious clinical problem, and still present an unmet need. We believe that current approaches to the treatment of chronic infections with nontuberculous mycobacteria (NTM) are insufficient, and that novel inhalable formulations of existing antibiotics can be developed and tested, in order to rapidly provide new therapeutic options for CF patients with such infections. QRUMPHARMA is systematically screening available and overlooked antibiotics, and reformulating those for inhalation, and for activity on the NTM biofilm. Chronic pulmonary NTM infections (both Mycobacterium abscessus, as well as Mycobacterium avium complex) and their biofilm components require specific solutions and techniques of the inhaled approach. The Qrum program has identified three novel formulations that serve the needs of CF patients with NTM infections. The preclinical program includes basic chemistry characterization, microbiology testing, biofilm testing, formulation development, and in vitro nebulization testing. In addition, the lead compound is being tested in a non-GLP inhaled toxicology model, to determine predictive tolerability and safety in a rodent. The proposed program will identify a lead compound ready for GLP testing, enabling an IND and first in human studies in 2019

 

General background on NTM and Qrum program

Nontuberculous Mycobacteria (NTM) infections are an increasing threat to Cystic Fibrosis patient’s health and survival. While the occurrence of these infections constantly increases, no approved therapy is available. This proposal is describing a work package to investigate how approved antibiotics, which normally are developed and given by injection or orally, can be re-designed to be inhaled. Given via inhalation, the drug will be available directly at the site of infection in the lung thus minimizing potential side effects caused by systemically administered antibiotics. The ongoing work utilizes novel formulation techniques, is redesigning and testing three or more such novel formulations, and thereby prepare the full clinical development of a new treatment for NTM in CF. The Qrum program is designed to identify an accelerated path to approval for a new NTM therapy, while more specific antibiotics are screened and developed in parallel.

Technology

 

Update

Content will be updated soon.

News and Press Releases

 

August 17, 2018

 

Qrumpharma Announces FDA Orphan Drug Designation for QRM-003 for the Treatment of pulmonary NTM infections

 

Qrumpharma Inc., a privately held pre-clinical drug development company developing therapeutics for prevention and treatment of infectious diseases, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to QRM-003 for the treatment of pulmonary infections with non-tuberculous mycobacteria (NTM). QRM-003 is a formulation based on a re-purposed antibiotic for inhalation administration.

 

The US FDA Orphan Drug Designation provides incentives for companies to develop drugs for rare diseases affecting fewer than 200,000 patients in the US. These incentives may include FDA assistance in clinical trial design, tax credits towards the cost of clinical trials, prescription drug user fee waivers, and potential market exclusivity for seven years following approval.

 

NTM infections can occur throughout the body, although pulmonary infections, lymphadenitis, and skin and soft tissue infections are the most common; NTM infections have been increasing worldwide over the past two decades; Treatment is typically prolonged and requires multi-drug regimens due to the risk of development of resistance.

 

 

July 11, 2018

 

FDA Grants Qualified Infectious Disease Product (QIDP) Designation to QRM-003, Qrumpharma’s Anti-infective Product Candidate

 

Qrumpharma Inc., a privately held pre-clinical drug development company developing therapeutics for prevention and treatment of infectious diseases, announced today that the US Food and Drug Administration (FDA) has granted a qualified infectious disease product (QIDP) designation to Qrumpharma’s investigational antiinfective product candidate, QRM-003. The QIDP designation is for the treatment of pulmonary infections with non-tuberculous mycobacteria (NTM).

 

The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act, which was part of the FDA Safety and Innovation Act of 2012 (FDASIA). It provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.

 

NTM infections can occur throughout the body, although pulmonary infections, lymphadenitis, and skin and soft tissue infections are the most common; NTM infections have been increasing worldwide over the past two decades; Treatment is typically prolonged and requires multi-drug regimens due to the risk of development of resistance.

 

 

October 10, 2017

 

Talk

 

See our latest presentation.

 

Thomas Hofmann

CEO, Qrumpharma

 

 

July 18, 2017

 

Funding and Progress update

 

To our friends, colleagues, and supporters

 

Qrumpharma has seen some great progress lately, and I thought it important to update the team and friends on what has happened over the last couple of months:

 

First, we have identified and understood our final two drug candidates for nontuberculous mycobacteria, which are QRM-003 (known drug reformulated) and QRM-006 (novel drug reformulated for inhalation). As part of that finalization, we have finalized a term sheet and material transfer agreement on the novel drug, with our Chinese partner.

 

Second (and perhaps most importantly), we have executed the contract with the CF Foundation, for a grant (non dilutive, and as a direct, non conditional payment) to develop our two drug candidates for NTM. We are now funded for the microbiological and animal proof of concept (by CFF), and for the formulation development of the drug candidates into an aerosol formulation. The points above are major accomplishments, and I want to thank Stefan Ufer and Brandon Banaschewski for their great and passionate work to get us the CFF grant. The funding from the CF Foundation validates our scientific approach and the great unmet need in NTM, and puts our work on the map. In addition, I have received an invitation to speak at the TB conference at Duke University in Durham, NC.

 

The next steps will be to rapidly execute on formulation, and on the above NTM testing (at Colorado State, and at Rutgers University), and use those results to further strengthen our Intellectual Property.

 

And last, we have brought in a substantial investment round, to fund operations (along with aerosol formulation, preclinical work and toxicology) for 1.5 to 2 years. Along with that come two phenomenal board members/advisors, each of them extremely valuable to Qrum strategy and development.

 

Our current focus is to increase our IP portfolio by producing formulation and animal data, execute the CFF funded experiments, and move fast towards the preclinical and toxicology experiments.

 

Please let me know if there are any questions about the development and company progress, or want to know more detail. We are excited and energized to make a difference in severe lung disease.

 

Thomas Hofmann

CEO, Qrumpharma

 

thofmann@qrumpharma.com

215-345-4150

Contact us

Contact Form

Contact Details

For further information or inquiries don't hesitate to contact us.

Dr. Thomas Hofmann, MD PhD

Top