IRLAB’s IRL752 is proposed pirepemat as a unique INN by WHO

August 3, 2020

IRLAB announced today that the World Health Organization (WHO) has proposed the name pirepemat as the International Nonproprietary Name (INN) for the company’s drug candidate IRL752, which is in development for decreasing the risk of falling in patients with Parkinson’s disease. Given the drug candidate’s unique mode of action, WHO concluded that IRL752 should not be incorporated into any existing INN stem in the classification system. IRL752 therefore has the potential to becoming a first-in-class treatment. The INN will identify the active pharmaceutical substance of IRL752 during its lifetime among healthcare professionals, scientists as well as patients worldwide.

Gunnar Olsson, chairman of the board at IRLAB, comments: “IRL752 is the second drug candidate from our pipeline that in a short time has been considered to be unique enough to propose a new classification of the drug candidate and future drug. This is yet another confirmation of the innovative power of IRLAB and our research platform, ISP. This also supports our vision to develop novel and innovative drugs with the potential to not only improve but rather transform the treatment of Parkinson’s disease. Our goal is to make a substantial difference for patients and their families with innovative novel therapies.”

Earlier this year, IRLAB received the unique INN mesdopetam for its drug candidate IRL790. Both pirepemat and mesdopetam indicate new INN stems. According to WHO regulations, a period of four months will now follow.If no major reason for objection is put forward, then  the proposed INN will be formally approved.

For more information

Nicholas Waters, CEO                
Phone: +46 730 75 77 01                
E-mail: nicholas.waters@irlab.se

About IRL752 (pirepemat)

IRL752 is being developed for the treatment of impaired balance (postural dysfunction) and falls in Parkinson’s disease. The results from a finalized clinical Phase IIa study, published in the journal Movement disorders, indicate that IRL752 has the potential to improve balance and reduce the risk of falls. IRL752 has the ability to increase the levels of the neurotransmitters norepinephrine and dopamine in the frontal cortex and activate specific genes involved in nerve cell connections. In clinical research, it has been shown that the neurotransmitters noradrenaline and dopamine are decreased in the frontal cortex in Parkinson’s disease. The effects of this reduction could be counteracted by treatment with IRL752 and then lead to improvement of balance, cognitive and psychiatric symptoms for these patients. A Phase IIb study with the drug candidate is planned to begin in 2020 to evaluate the effects of IRL752 on fall rate as compared to placebo.

About the INN system

The INN system is a WHO governed classification system that has been established to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients in a unique and globally recognized manner. Through the system, healthcare professionals are provided with a clear identification of a drug enabling a safe prescription and dispense of medicine to patients. The proposal and recommendation of an INN, also known as a generic name, therefore, marks an important preparatory step for a drug candidate’s marketing authorization and subsequent launch.

About IRLAB

IRLAB is a Swedish biotech company focused on Parkinson's disease. The company's clinical Phase 2 candidates, IRL752 and mesdopetam (IRL790), intend to treat some of the most difficult symptoms related to Parkinson's disease: involuntary movements (LIDs), psychosis and dementia. Through the proprietary ISP (Integrative Screening Process) research platform, IRLAB discovers and develops drug candidates for central nervous system (CNS) related diseases where big growing medical needs exist. In addition to the clinical candidates, the ISP platform has also generated several CNS programs that are now in preclinical phase. IRLAB's Certified Adviser on Nasdaq First North is FNCA Sweden AB, info@fnca.se, +46 (0)8‑528 00 399. More information on www.irlab.se.

Quotes

"IRL752 is the second drug candidate from our pipeline that in a short time has been considered to be unique enough to propose a new classification of the drug candidate and future drug. This is yet another confirmation of the innovative power of IRLAB and our research platform, ISP. This also supports our vision to develop novel and innovative drugs with the potential to not only improve but rather transform the treatment of Parkinson’s disease. Our goal is to make a substantial difference for patients and their families with innovative novel therapies." Gunnar Olsson, chairman