CRST Oy and Gabather AB have announced collaboration in development of Gabather drug candidate GT-002

Gabather AB and CRST have initiated cooperation to prepare Gabather’s CNS active substance GT-002 for the clinical development.
    CRST’s CSO, Professor Mika Scheinin comments: “We are really happy that Gabather chose to collaborate with CRST in early clinical development based on our experience and scientific knowledge. We are looking forward to work with this interesting compound. Our aim is to help our customers to get as much information about their compounds as early as possible and we are very much looking forward to do that with Gabather.”

  • September 7, 2017
  • Ville Ranta-Panula
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“We look forward to work with Gabather’s team in this interesting development program during planning and consultation phase and also during the actual clinical conduct. The two teams have worked well together to facilitate the development plan for GT-002. We are also really happy that we can see new business in Nordics.” comments Antti Iitiä, CEO of CRST.

About CRST:

CRST Oy is a Finnish contract research organization (CRO) with over 20 years of experience of clinical trials. CRST Oy is run by experienced specialists with in-depth understanding of basic and clinical pharmacology and drug development, including clinical trial management. CRST’s core expertise lies in the understanding of disease mechanisms. Specialists from different fields participate in CRST’s operations as principal investigators and scientific consultants. CRST’s clients include many leading Finnish, Nordic and multinational Pharma companies. CRST’s services comprise clinical study design, study conduct and reporting, and regulatory affairs.

About Gabather:

Gabather AB was founded in 2014, based on 10 years research at Lund University, to develop novel drug candidates for the treatment of several diseases originating in the central nervous system (CNS). Since there are several areas of unmet need as well as many medicines going off-patent, it is an opportune moment to develop new drugs targeting the CNS area.

Serodus and CRST published results on effects of SER100 in patients with isolated systolic hypertension

Serodus (Oslo Axess: SER) and CRST are pleased to inform that an article on SER100 has been published in Clinical Pharmacology in Drug Development under the title “Safety, tolerability and antihypertensive effect of SER100, an Opiate Receptor-Like 1 (ORL-1) partial agonist, in patients with isolated systolic hypertension”.

  • January 25, 2017
  • Ville Ranta-Panula
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“We are happy that these encouraging results are now published and we could give our contribution also to the publication. This is a good example of how a small but professional study site can have a big impact on patient recruitment. CRST in collaboration with Turku University Hospital recruited 13 out of the 17 patients included into the multinational trial,” says one of the authors, Chief Scientific Officer of CRST, Professor Mika Scheinin.

“SER100 is the first compound Serodus tested in a clinical study, and it is now very encouraging to publish the clinical findings in patients with a condition that is common in elderly people,” says CEO of Serodus, Professor Eva Steiness. “We are really happy with the performance of CRST in this trial and we are looking forward to further collaboration,” Steiness adds.

Abstract of the article:

The purpose of the present study was to evaluate safety, tolerability and effect on systolic blood pressure (SBP) of SER100 in a group of 17 patients with isolated systolic hypertension (ISH) in treatment with at least one antihypertensive drug. Eligible patients were randomized to either SER100 (10 mg) or placebo in a cross-over design. Patients were dosed twice daily during two days. Patients were monitored with ambulatory blood pressure measurement for 12 daytime hours.

There were no serious or severe adverse events. Relative to placebo SER100 induced an average reduction of SBP during the two treatment days of 7.0 mmHg (p = 0.0032), whereas the average reduction of diastolic blood pressure (DBP) over the same period was 3.8 mmHg (p = 0.0011). For patients with ISH, this short-term cross-over study of s.c. SER100 demonstrated an acceptable safety profile and consistent, significant lowering of SBP and DBP. The publication is available here.
About SER100: SER100 is an OLR-1 receptor agonist and has a new mode and site of action in the treatment of patients with ISH. Ser100 has also demonstrated efficacy in experimental animal models of pulmonary hypertension. SER100 has received approval for orphan drug status in pulmonary arterial hypertension by the FDA.

About Serodus:

Serodus ASA (Oslo Axess: SER) is a Scandinavian drug development company, focusing on new therapeutic products for the treatment of diabetes and diabetic comorbidities with large unmet clinical needs.

CRST Oy and Vicore Pharma have conducted SAD and MAD studies

Clinical Research Services Turku –CRST Oy and Vicore Pharma have successfully conducted SAD and MAD studies with C21, Vicore Pharma’s novel AT2 receptor agonist. All of the objectives of the two Phase I studies were met; C21 was found to be safe and well tolerated in the investigated dose range (up to 100 mg daily), and its pharmacokinetic properties were acceptable for further clinical development.

  • January 2, 2017
  • Ville Ranta-Panula
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The company can now continue to develop its clinical candidate C21 to a future drug for the treatment of pulmonary fibrosis, an orphan indication that was recently granted to C21 by the European Commission.

“We are very satisfied with the results of the studies. The outcome is exactly what we expected and hoped for. We have information on the absorption of C21 in humans and we know that it has been well tolerated even at repeated and increasing dosages. C21 is thus considered to be a platform for clinical development, primarily for pulmonary fibrosis, but hopefully also for other rare diseases where we have strong animal data. The company is now intensifying discussions with potential partners for the next stage of development” says Vicore’s CEO Per Jansson.

“We are happy to assist Vicore Pharma in its clinical development of C21 and we are pleased that the studies have passed uneventfully. We now look forward to the next steps in the development of this exciting new drug with significant potential in the treatment of idiopathic pulmonary fibrosis”, says Professor Mika Scheinin, Chief Scientific Officer of CRST.

“We are really happy about this strong collaboration with Vicore and happy to be part of this very promising and exciting development program”, says Antti Iitiä, CEO of CRST Oy.

The two Phase I studies were carried out between May 2016 and November 2016 and comprised 48 healthy volunteer subjects. Both studies followed standard double-blind, randomized, placebo-controlled ascending-dose designs and aimed to evaluate the safety, tolerability and pharmacokinetics of C21.

About Vicore Pharma

Vicore Pharma develops new pharmaceuticals based on stimulating the AT2 receptor in the Renin-Angiotensin-System (RAS). Our vision is to establish selective AT2 agonists as effective and safe drugs for serious disease where inflammation, fibrosis and/or neuronal damage are significant pathophysiologies. For a first indication, the company is aiming at developing C21 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The parent company to Vicore Pharma, Vicore Pharma Holding is listed on Nasdaq First North, a small cap list on the Stockholm stock exchange. The company’s certified adviser is Redeye AB.

Alzinova AB and CRST Oy have initiated a cooperation

Alzinova AB and CRST have initiated a cooperation to prepare Alzinova’s Alzheimer’s vaccine, ALZ-101, for the first in man clinical trial. The joint project will review pre-clinical and scientific documentation and finalize a clinical study protocol for the vaccine. Both companies will also together seek scientific advice with the relevant regulatory authorities. The aim is to submit a clinical trial application for ethical and regulatory approval by the end of 2017.

  • September 30, 2016
  • Ville Ranta-Panula
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“We are very happy to now advance into the next phase in our mission to develop a disease modifying treatment for Alzheimer’s. We are also very happy to be able to do this together with CRST, who has successfully managed a number of similar trials within Alzheimer’s before. Their knowledge and solid expertise give us a great advantage as we now move into the first detailed steps towards the clinic. We are also very glad that we can start these procedures in good time, so that our goal of moving into clinical phase in 2018 can be reached,”says Per Wester, the CEO of Alzinova.

“We are glad to be able to cooperate with Alzinova in this interesting project. Collaboration in Nordic countries works well and is very interesting with high quality professionals like people at Alzinova,” says Antti Iitiä, Managing Director of CRST Oy.

About Alzinova AB

Alzinova AB (556861-8168) is a pharmaceutical enterprise engaged in drug discovery research for Alzheimer’s disease – one of our biggest health care problems where there is no available treatment. Alzinova’s proprietary AβCC peptide™ technology enable us to explore novel therapeutics with potential to target the toxic oligomers that are central in the disease development. Our focus is to develop a vaccine as disease modifying treatment and prevention. The vaccine is in pre clinical phase. The company also develop diagnostic tools for the disease. Alzinova was founded by scientists based at MIVAC research center within Gothenburg University and by GU Ventures AB.

CRST Oy and Vicore Pharma have started collaboration

A First in Human trial of C21, Vicore Pharma’s novel AT2 receptor agonist, was conducted on healthy male volunteers at CRST in Turku, Finland. The single ascending dose study comprised six dose levels of C21 to evaluate the safety, tolerability and pharmacokinetic properties of the drug. There were no serious adverse reactions reported in the study and C21 appeared safe in doses ranging from 0,3 to 100 mg.

  • September 08, 2016
  • Ville Ranta-Panula
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”We are happy to assist Vicore Pharma with this first-in-man study and we are pleased that the study has passed uneventfully. We now look forward to evaluating also multiple dosing of this exciting new drug with significant potential in the treatment of idiopathic pulmonary fibrosis”, says Professor Mika Scheinin, Chief Scientific Officer of CRST. “It is also great that Vicore wanted to make this collaboration public; this was truly a first-in-man trial as C21 has a novel target,” Scheinin added. This study is an ideal example of the high level of medical science and strong collaboration inside Scandinavia. We are happy to be part of this very promising and exiting development program, says Antti Iitiä, Managing Director of CRST Oy.

”To us and all of our research partners who have dedicated much effort and resources on C21, this is an important milestone that brings us confidence as we advance C21 towards patients with this rare but serious condition, idiopathic pulmonary fibrosis”, says Per Jansson, Managing Director of Vicore Pharma.

As a next step, a multiple ascending dose study on healthy male volunteers will be initiated. Results from this study are expected by the end of 2016. ”The selection of strategic collaboration partners is highly critical for us as a small company and we are very pleased with the high degree of quality and professionalism of both CRST and the manufacturer of the investigational product, SP Process Development”, says Lena Lindblad, Ph.D., project leader at Vicore Pharma. See Vicore’s original press release here.

About Vicore Pharma

Vicore Pharma develops new pharmaceuticals based on stimulating the AT2 receptor in the Renin-Angiotensin-System (RAS). Our vision is to establish selective AT2 agonists as effective and safe drugs for serious disease where inflammation, fibrosis and/or neuronal damage are significant pathophysiologies. For a first indication, the company is aiming at developing C21 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The parent company to Vicore Pharma, Vicore Pharma Holding is listed on Nasdaq First North, a small cap list on the Stockholm stock exchange. The company’s certified adviser is Redeye AB.

New tools for early clinical development

CRST is announcing that CRST’s Phase I-II unit in Turku, Finland is now a certified site in iCardiac’s Early Precision QT Program. The certification enables CRST to offer iCardiac’s Early Precision QT services for evaluating the cardiac safety of new compounds in early-phase clinical trials. This solution provides study sponsors with an early evaluation of the cardiac safety risks of their investigational new drug and potentially eliminates the need for a later, separate Thorough QT (TQT) study.

  • March 23, 2016
  • Ville Ranta-Panula
  • Link

“Our aim is to help our customers to get as much information about their compounds as early as possible. Our tools have earlier included for example PET imaging, EEG etc. This Early Precision QT service is a great addition to our toolbox. We can now help our customers evaluate the cardiac safety of their compounds already in clinical Phase I trials, which will enable them to prioritise drug candidates with strong safety profiles and may eliminate the need for later-stage TQT studies, with very significant cost savings,” says CRST’s Chief Scientific Officer, Professor Mika Scheinin.

About Early Precision QT® services

Assessing cardiac safety much earlier in the drug development process, by using data collected from routine Phase I studies, is now a strategy that is fully accepted by international regulatory agencies. In December 2015, the International Council for Harmonisation revised the guidance that defines and enables an alternative path to the conduct of a Thorough QT study. Likely the most significant regulatory shift in cardiac safety since the original E14 Guidance was adopted in 2005, the new revision emerged following the successful conduct of a prospective validation study in 2014 that was sponsored by iCardiac, using their personnel and technology to perform the critical data analysis.