Galimedix Therapeutics, Inc.’s GAL-101 Gains from Target Validation by Positive Phase 3 Results of Biogen’s Aducanumab

KENSINGTON, Md., Oct. 29, 2019 (GLOBE NEWSWIRE) — Galimedix Therapeutics, Inc., an emerging leader in the development of new solutions for neurodegenerative diseases of the retina and the brain, today announced that the recent positive results of a Phase 3 study in Alzheimer's disease with Biogen's aducanumab also validate the target of the company's lead molecule, GAL–101.

"Following decades of failure in large Alzheimer neuroprotection trials, the recent Biogen announcement may be considered a breakthrough and a validation of amyloid beta oligomers as a target for new Alzheimer drugs," commented the company's chief scientific officer, Hermann Russ, M.D., Ph.D. "Aducanumab and GAL–101 share that they both clear the highly toxic amyloid beta oligomers. However, GAL–101 has the advantage of being a small molecule and blocks the formation of all forms of toxic oligomers at source while the antibody eliminates them only after their formation."

Aducanumab is an antibody binding specifically to aggregated amyloid beta monomers, which are also called amyloid beta oligomers. The company considers the recently announced aducanumab results in Alzheimer's disease to be validation for GAL–101 eyedrops, which target the same amyloid beta pathology in dry macular degeneration (AMD) and glaucoma. A Phase 2 program in these two indications using GAL–101 eyedrops is currently under development. An additional oral formulation of GAL–101 is in IND–enabling studies and the company believes studies in Alzheimer patients with GAL–101 capsules could start in 2021.

"These results represent a long–awaited reward for companies like Galimedix that never gave up their strong belief in amyloid beta being the right target for Alzheimer's disease, if only addressed appropriately," added Galimedix' executive chairman of the board, Alexander Gebauer, M.D., Ph.D. "Small molecules like GAL–101 have the potential to revolutionize the treatment of amyloid beta–driven diseases like dry AMD, glaucoma and Alzheimer s. We look forward to continuing to learn about the aducanumab results, as well as to sharing our own successes in targeting amyloid beta."

About Galimedix Therapeutics, Inc.
Based in the United States and Israel, Galimedix is a Phase 2/3–ready pharmaceutical company with a world–class drug development team advancing a novel, patented small molecule drug with a unique MOA addressing glaucoma, dry AMD. The company's most advanced compound, GAL–101, which utilizes an eye drop delivery platform, is expected to provide an effective, convenient and safe treatment for two of the leading causes of blindness. Studies with Galimedix's eye drops in monkeys, the closest model to humans, have demonstrated that therapeutic levels are quickly reached in the retina. Compelling efficacy data from GAL–101 eye drops in relevant animal models have demonstrated more than 90 percent neuroprotection, and in vitro studies in neuronal cells that have lost function have shown that GAL–101 can restore the neural function, suggesting it could potentially improve visual function in patients. The Company has successfully completed Phase 1 studies in 70 subjects, including 30 glaucoma patients. The compound is supported by many of the world's leading experts in glaucoma and in dry AMD, who also support the design of the company's proposed Phase 2 and Phase 3 studies.

GAL–101 is also potentially capable for oral delivery and is in active development towards Phase 1 studies with the oral formulation. In this oral formulation GAL–101 can be developed as treatment of Alzheimer's disease.

Contact:

Jules Abraham
Core IR
julesa@coreir.com
917–885–7378

India has a Groundwater Problem

"Our wells and springs are drying up, and as a consequence of this depletion, our groundwater quality is also deteriorating" Credit: Manipadma Jena/IPS

“Our wells and springs are drying up, and as a consequence of this depletion, our groundwater quality is also deteriorating” Credit: Manipadma Jena/IPS

By Rachita Vora and Smarinita Shetty
MUMBAI, India, Oct 29 2019 – A majority of India’s water problems are those relating to groundwater—water that is found beneath the earth’s surface. This is because we are the largest user of groundwater in the world, and therefore highly dependent on it.

At just over 260 cubic km per year, our country uses 25 percent of all groundwater extracted globally, ahead of USA and China. And because 70 percent of the water supply in agriculture today is groundwater, it will remain the lifeline of India’s water supplies for years to come.

Despite this, we have an extremely poor understanding of groundwater, which impacts both policy and practice. In our conversation with Himanshu Kulkarni and Uma Aslekar of Advanced Centre for Water Resources and Development (ACWADAM), they walk us through some of the reasons why this is the case.

 

Why is it that we neither understand nor prioritise groundwater in our policies?

This is largely because of two reasons: Groundwater is invisible—it is literally not visible to the eye because it is well below the ground. What is out of sight, is usually out of mind! Groundwater is also a highly complex subject that is governed by many ‘conditionalities’. It is this ignorance, by both users and people in governance, that has contributed to the situation we find ourselves in today.

Moreover, groundwater education still focuses largely on ‘exploring’ new sources of groundwater that will lead to the ‘development’ of groundwater resources. The subject of groundwater in aquifers is often considered quite complex as compared to providing groundwater supplies from wells, even if these wells continue to become deeper and deeper as groundwater levels decline. In the gap between supply on one side, and demand on the other, we are losing out on components of groundwater management from many systems of education delivery.

We need a demystified but correct understanding of aquifers (underground rocks that are sources of groundwater), their properties and how they are used, so that we can make the critical mass of users and decision makers understand them and act on them appropriately.

 

 

We neither understand nor prioritise the groundwater issue because what is out of sight, is usually also out of mind. | Illustration – Priya Dali

We neither understand nor prioritise the groundwater issue because what is out of sight, is usually also out of mind. | Illustration – Priya Dali

 

What will that take?

We at ACWADAM conduct training programmes for various organisations and government agencies. If one is explaining the concept of aquifers, for instance, the semantics, pedagogy, and the delivery of training on the whole will need to be different for different stakeholders.

If one has to explain aquifers to a groundwater agency, hydrogeologists, or people with a technical background, one will need to use a different language than that when one is speaking to communities and end users.

Similarly, the lexicon on groundwater will need to be completely different if one is talking to decision makers and technocrats, who have no technical knowledge on the subject. The ability to clearly articulate and communicate the groundwater problem and the possible solutions, is therefore, the key to implementing processes of groundwater management.

 

If you were to state, simply, the primary issues when it comes to groundwater in India, what would they be?

There are basically three issues. The first is depletion. Our wells and springs are drying up, and as a consequence of this depletion, our groundwater quality is also deteriorating.

When there is less water in an aquifer, the concentration of ions increases. When aquifers get recharged sufficiently, contaminants are diluted. Whether it is groundwater use in agriculture or in domestic supply, serious issues of contamination like fluoride and arsenic, which are no longer isolated cases and are found across large regions of the country, must be addressed. This contamination is the second problem, and it is very often related to the first problem of depletion.

We need a demystified but correct understanding of aquifers (underground rocks that are sources of groundwater), their properties and how they are used, so that we can make the critical mass of users and decision makers understand them and act on them appropriately

The third, which is not readily perceived as a problem, is that of the increasing disconnect between groundwater and ecosystems, particularly due to the environmental impact of depletion and contamination. As a consequence of large-scale groundwater usage for human needs, the value of the service that aquifers provided to the environment—say to river flows—has significantly reduced. How does one then make the connection between the environment and groundwater, especially when that connection has been altered and severed?

Therefore, we need an integrated approach. Even if in one area, depletion seems to be the biggest problem, we need an approach that addresses contamination, and recognises the ecosystem role of groundwater in resolving the problem of depletion. Doing one and not the other will not help resolve any one problem in its entirety.

 

How then, do we solve the problem in its entirety, at scale?

Broad brush approaches implemented at scale will not work. Let us consider an example: you have a new idea to solve a groundwater problem, and it has five critical elements. The district you are working in has 20 talukas. You cannot implement all five components of your idea in those 20 talukas. So, what will you do? You will likely take the easiest option and leave the rest. This doesn’t work out since the complex natures of aquifers and human behaviours cannot be solved with a broad brush of a simple, big ticket solution. You need an appropriate (scientifically validated) and acceptable (communities must be able to agree and co-operate in implementation) solution to make impact.

Alternatively, you might choose to implement all five ideas in one village of each taluka, where they are possible to implement. But then scaling-out such solutions becomes challenging. There are thus no big-ticket solutions in groundwater. All the same, it is necessary to work at the micro level even though it is challenging to engage with policy makers who would rather have groundwater solutions that run across large swathes of the landscape; many of them would prefer solutions at scale that create a buzz in the short-term rather than an impact in the longer-term.

 

Given these inherent challenges, what is it that India needs to do?

If we are to address our water problems, there are a few things that the country needs:

 

Aggregate micro-level solutions to construct a larger picture that can inform policy

Groundwater in India is rather disaggregated in terms of its occurrence, usage, and problems. Hence, we need disaggregated approaches leading to customised solutions that are appropriate to locations and situations of groundwater problems. Further, it is important to pull together these smaller solution pieces to construct a larger picture. This is the reason why we need practitioners who have worked on the ground and attempted to solve the problems, to be actively involved in policy framing; else, things will not change and the divide between policies, and practices on groundwater management will only continue to widen further.

 

Stronger public institutions dedicated to groundwater management

Additionally, we have an institutional vacuum when it comes to dealing with groundwater. Let us consider an example from Maharashtra. More than 80 percent of Maharashtra’s rural drinking water supply comes from groundwater wells. Protecting and sustaining this source is a function of how groundwater is used in agriculture so that drinking water supply in the villages of the state remains secure.

The Ground Water Survey and Development Agency (GSDA) falls under the ambit of the Ministry of Drinking Water and Sanitation. It has little to do with water used for agriculture—which accounts for less than 5 percent of water used in rural Maharashtra—and hence cannot influence policy or usage with respect to that. Organisations like GSDA must be strengthened and encouraged to engage in partnership models of working with grassroots organisations that are working on community-level water management.

This is just one example of how a lack of institutional thinking impacts solutions. Many states don’t even have a GSDA equivalent. Strengthening agencies dealing with groundwater becomes quite important in this regard.

 

To demystify the science and involve people in solution-making

Some important questions we need to consider include: How does one get people to participate and cooperate in efforts dealing with groundwater management? How do communities convert competition and conflict to participation and cooperation? Our experience at ACWADAM is that when you undertake an effort in demystifying science, and involve communities and committed people in the development of that science, you can achieve improved decision making at any level. And once you achieve this, your outcomes automatically change even though they are often not ideal. However, even such imperfect outcomes significantly enhance water security in regions that depend on groundwater.

 

More attention and investment in promoting partnerships and collaborations

There is a grave need for infusing interdisciplinary science in the processes of groundwater management and governance. Only if and when such science is made to bear upon achieving decentralised water governance, will we be able to solve many problems on groundwater. It is important, therefore, to realise that no single agency holds the key to problem identification and resolution in the sector of groundwater. Hence, catalysing collaborations that integrate the many disciplines required to develop sustainable groundwater management solutions, is needed; such partnerships must form the backbone of public efforts to protect, restore, and manage groundwater resources.

 

 

Rachita Vora is Co-founder and Director at IDR. Before this, she led the Dasra Girl Alliance, a Rs. 250 crore multi-stakeholder platform that sought to improve maternal and child health outcomes, and empower adolescent girls in India. She has over a decade of experience, having led teams in the areas of financial inclusion, public health and CSR. She has also led functions across strategy, business development, communications and partnerships, and her writing has been featured in the Guardian, Stanford Social Innovation Review, Next Billion and Alliance Magazine. Rachita has an MBA from Judge Business School at Cambridge University and a BA in History from Yale University.

 

Smarinita Shetty is Co-founder and CEO at IDR. She has more than 20 years of experience leading functions across strategy, operations, sales and business development, largely in startup environments within corporates and social enterprises. Prior to IDR, Smarinita worked at Dasra, Monitor Inclusive Markets (now FSG), JP Morgan and The Economic Times. She also co-founded Netscribes–India’s first knowledge process outsourcing firm. Her work and opinion have been featured in The Economist, Times of India, Mint and The Economic Times. Smarinita has a BE in Computer Engineering and an MBA in Finance, both from Mumbai University.

 

This story was originally published by India Development Review (IDR)

Industrial Policy Still Relevant

By Jomo Kwame Sundaram and Anis Chowdhury
KUALA LUMPUR and SYDNEY, Oct 29 2019 - Industrial policy refers to the promotion of new investments and technology by governments to encourage the growth and development of specific economic [...] Read more »